Industry News
Covid-19
Dec 02, 2024

BRONX, N.Y. - A new study led by researchers at Albert Einstein College of Medicine involving more than 200,000 adults found that the COVID-19 pandemic caused a 29% increase in risk for developing dyslipidemia, a condition involving abnormal lipid (fat) levels in the blood. Seniors and people with type 2 diabetes were even more strongly affected, experiencing an approximately two-fold increased risk for developing dyslipidemia, which is a major risk factor for cardiovascular diseases such as heart attack and stroke. The research was published today in the print edition of The Journal of Clinical Investigation.

"Given the extent of the pandemic, this increase in dyslipidemia risk is a cause for concern around the world," said study leader Gaetano Santulli, M.D., Ph.D., associate professor of medicine and of molecular pharmacology at Einstein. "Based on our findings, we would advise people to have their lipid levels monitored regularly and to consult with their healthcare providers about ways to treat dyslipidemia if detected, especially elderly individuals and patients with diabetes." He noted that this advice would apply to all adults, not just those formally diagnosed with COVID-19, considering that many people have been infected without realizing it.

To put these findings into context, it has been estimated that 53% of U.S. adults had dyslipidemia before the pandemic; a 29% increase in dyslipidemia incidence due to COVID-19 would mean that 68% of Americans may now be at risk for having lipid abnormalities.

In two previous studies, Dr. Santulli and his team found that COVID-19 raised the incidence of new cases of hypertension and type 2 diabetes. "In those analyses, we demonstrated that the risk of developing these disorders was still high three years after the pandemic; moreover, we noticed a suspicious increase in total cholesterol levels, which warranted a closer look," said Dr. Santulli. In the new study, the researchers first determined the incidence of dyslipidemia in a group of more than 200,000 adults living in Naples, Italy during the three years prior to start of the pandemic (2017-2019). They then assessed the incidence of dyslipidemia in the same group during the three-year COVID-19 period (2020-2022), excluding from the analysis those people earlier diagnosed with dyslipidemia or who had previously been taking lipid-lowering medications.

The investigators found that COVID-19 raised the risk for developing dyslipidemia in the entire study group by an average of 29%. The increase was even higher among people over age 65 and those with chronic conditions, particularly diabetes and obesity, cardiovascular disease, chronic obstructive pulmonary disease, and hypertension. The findings are the most definitive to date because other studies—most of them linking COVID-19 with modestly increased risks for blood-lipid problems—used as control groups different populations or people thought to have gone through the pandemic without becoming infected. However, significant numbers of people classified as "COVID-free" actually developed the disease but were either never tested or didn't seek medical care.

"Our study did not attempt to determine whether participants had tested positive for COVID-19," Dr. Santulli said. "Instead, because we had been following this group for many years prior to the pandemic, we were able to measure COVID's overall impact on the population by simply comparing levels of dyslipidemia in the same group before and after the pandemic. Any increase in dyslipidemia incidence would almost certainly have to be the result of COVID-19."

How COVID-19 might have increased the incidence of dyslipidemia remains unclear. One possible explanation is a finding Dr. Santulli made in an earlier study: that SARS-CoV-2 (the virus that causes COVID) disrupts the function of endothelial cells, which line the inside of blood vessels throughout the body and play a critical role in regulating blood lipids.

A separate study found that COVID-19 is a powerful risk factor for heart attacks and strokes for as long as nearly three years after an infection. "This investigation, published online a month after ours, essentially confirms our observations in this study, since dyslipidemia is a major contributor to cardiovascular disease," said Dr. Santulli. "It also suggests that tackling dyslipidemia should reduce the risk of cardiovascular disease in those who have had COVID."  

The researchers are now studying the effects of COVID-19 on cardiovascular-kidney-metabolic (CKM) syndrome, a recently described condition involving four connected medical problems—heart disease, kidney disease, diabetes, and obesity—all of which involve endothelial dysfunction.

The study is titled "A six-year study in a real-world population reveals an increased incidence of dyslipidemia during COVID-19". The other contributors include: Stanislovas S. Jankauskas, Ph.D., and Fahimeh Varzideh, Ph.D., both at Einstein, Pasquale Mone, M.D., Ph.D., at Einstein and Molise University, Campobasso, Italy, Valentina Trimarco, Raffaele Izzo, Maria Virginia Manzi, Maria Lembo, Paola Gallo, Giovanni Esposito, and Francesco Rozza, at the Federico II University of Naples, Italy, Roberto Piccinocchi, at the Vanvitelli Hospital, Naples, Italy, Carmine Morisco and Bruno Trimarco, at the International Translational Research and Medical Education (ITME) Consortium and Federico II University of Naples, Gaetano Piccinocchi, at the Italian Society of General Medicine, Mario Fordellone and Giuseppe Signoriello, at the Campania University, Naples, Italy.

medical lab
Nov 29, 2024

COVINGTON, KY - Bexion Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing a novel class of biologic therapy to treat advanced solid tumors and chemotherapy-induced peripheral neuropathy (CIPN), announces the publication of first-in-human data from a Phase 1 study of BXQ-350 in Clinical Cancer Research, an American Association of Clinical Research (AACR) journal. The study showed that BXQ-350 was well-tolerated with no dose-limiting toxicities. BXQ-350 is currently being studied for the first line treatment of metastatic colorectal cancer (mCRC).

"These data provide a large body of work on the use of BXQ-350 in patients," said Robert Wesolowski, MD, Clinical Professor of Internal Medicine at the James Cancer hospital and the Ohio State University Comprehensive Cancer Center. "In a population with such advanced disease, the fact that two patients are alive without disease progression seven years after initiating BXQ-350 treatment is remarkable."

The publication highlights adverse event and efficacy data, including multiple patients who survived more than six months without disease progression. The study enrolled 86 patients across over 20 different tumor types, including advanced metastatic disease and high-grade glioma. Preliminary PK data showed that BXQ-350 exhibited linear exposure, crossing the blood–brain barrier and accumulating in relevant tissues.

"We are excited to have our Phase 1 monotherapy data published in Clinical Cancer Research," said Jim Beach, CEO and President of Bexion Pharmaceuticals. "These data demonstrate the safety and tolerability of BXQ-350 in a large population with advanced solid tumor disease and high-grade glioma. We are now generating data on the use of BXQ-350 in metastatic colorectal cancer."

The Phase 1b/2 trial (ASIST study; NCT05322590) is currently underway evaluating BXQ-350 in combination with the standard of care in newly diagnosed patients with mCRC.

FDA Approved Stamp
Nov 26, 2024

The U.S. Food and Drug Administration (FDA) approved revumenib on November 15, 2024, for relapsed or refractory acute leukemia with a KMT2A translocation. This marks a significant development in cancer treatment, as the drug, first administered to a patient at Florida Cancer Specialists & Research Institute, LLC (FCS) in 2019 during a Phase 1 clinical trial, is now accessible nationwide.

The first patient to receive this treatment was referred by FCS medical oncologist/hematologist Muhammad Imam, MD, to FCS Director of Drug Development Manish R. Patel, MD, at the Sarasota Drug Development Unit (DDU). The Sarasota DDU is one of three early-phase clinical trial sites within the statewide practice. This milestone highlights FCS' role in the journey of this drug from trial to FDA approval, emphasizing its potential to target and treat MLL-rearranged leukemia.

"This latest FDA approval of revumenib is a testament to the power of innovation and collaboration—values deeply embedded in our practice's history," said FCS President & Managing Physician Lucio N. Gordan, MD. "Since treating the first patient in 2019, we've believed in the transformative potential of this therapy for leukemia patients. It's moments like these that affirm our longstanding commitment to advancing oncology care through research. This milestone not only validates that belief but also brings hope to countless individuals facing this devastating disease, reflecting the unwavering dedication of our team to improving lives."

Acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL) are rare and aggressive blood cancers often resistant to standard treatments. Revumenib is designed to target the genetic abnormalities driving these diseases, showing significant promise in clinical trials by improving remission rates and overall survival.

Dr. Patel, principal investigator for the FCS clinical trial, reflected on the approval: "Conducting this trial was an extraordinary scientific and clinical journey. We observed firsthand the profound impact this therapy had on patients who previously faced limited treatment options. The FDA's approval represents the culmination of years of rigorous research, collaborative effort, and the unwavering commitment of our team. Most importantly, it honors the bravery of the patients who participated and trusted us to pursue this innovative approach."

FCS contributed to the drug's development through its collaboration with Sarah Cannon Research Institute. The FDA approval reflects years of global medical and scientific collaboration.

With three early-phase drug development sites and 30 late-phase locations across Florida, FCS operates one of the nation's largest oncology research programs. Patients have access to over 180 clinical trials at any time, and more than 600 individuals receive cutting-edge treatments annually. Many of the cancer drugs recently approved for use in the U.S. included trials involving FCS' contributions, underscoring its pivotal role in advancing oncology care.

digital image of heart
Nov 22, 2024

INDIANAPOLIS, IN - Eli Lilly and Company announces positive Phase 2 results for muvalaplin, an investigational once-daily, orally administered selective inhibitor of lipoprotein(a) [Lp(a)], a genetically inherited risk factor for heart disease. The study demonstrated that muvalaplin significantly reduced elevated Lp(a) levels in adults, meeting its primary endpoint of percent change in Lp(a) from baseline to week 12.

At the 12-week primary endpoint, muvalaplin (10 mg, 60 mg and 240 mg) showed significant reductions in Lp(a) levels compared to placebo. The placebo-adjusted reductions were up to 85.8% using an intact Lp(a) assay and up to 70.0% using an apo(a) assay. Specifically, the reductions were 47.6% (10 mg), 81.7% (60 mg) and 85.8% (240 mg) with the intact Lp(a) assay, and 40.4% (10 mg), 70.0% (60 mg) and 68.9% (240 mg) with the apo(a) assay.

"High levels of Lp(a) have been shown to be a significant risk factor for atherosclerotic cardiovascular disease, affecting over one billion adults globally," said Stephen J. Nicholls, MBBS, Ph.D., director of the Victorian Heart Hospital and Institute, and professor of cardiology at Monash University, Australia. "Current cholesterol-lowering therapies are not approved to lower Lp(a) levels, highlighting an unmet need for people living with cardiovascular disease. These data represent a needed scientific advancement with the potential to reduce the risk of cardiovascular events such as heart attacks or strokes with a once-daily pill."

Lilly is evaluating muvalaplin, a potent, multivalent, small molecule that inhibits the formation of Lp(a) by blocking the initial interaction between apolipoprotein(a) [apo(a)] and apolipoproteinB (apoB). In the U.S., about 20% of people, or approximately 63 million individuals, have high levels of Lp(a).1,2 Elevated Lp(a) levels can double or even triple the risk of a heart attack and are associated with other cardiovascular issues.3

"While injectable approaches for Lp(a) are currently in Phase 3 development, including Lilly's own lepodisiran program, these are the first positive Phase 2 data for an oral approach," said Ruth Gimeno, Ph.D., group vice president, Diabetes and Metabolic Research, Lilly Research Laboratories. "We are very pleased to see these promising results and look forward to further exploring next steps for muvalaplin."

Muvalaplin also met secondary endpoints for all three tested doses (10 mg, 60 mg and 240 mg). The three tested doses achieved statistical significance for Lp(a) thresholds, and the 60 mg and 240 mg doses also achieved statistical significance for apoB reductions. These data also demonstrated:

Using the intact Lp(a) assay, the percentage of participants achieving an Lp(a) level less than 125 nmol/L at week 12 was 64.2% (10 mg), 95.9% (60 mg) and 96.7% (240 mg), compared to 6.0% in the placebo group.

Using the apo(a) assay, the percentage of participants achieving an Lp(a) level less than 125 nmol/L was 38.9% (10 mg), 81.9% (60 mg) and 77.4% (240 mg), compared to 3.6% in the placebo group.

ApoB levels were reduced at all doses, with placebo-adjusted reductions of 8.9% (10 mg), 13.1% (60 mg) and 16.1% (240 mg).

Adverse events were similar in both the muvalaplin and placebo groups. Treatment-emergent adverse events related to the study drug occurred in 14.9% of the placebo group, 5.9% of the 10 mg group, 14.3% of the 60 mg group and 14.7% of the 240 mg group. The incidence of adverse events leading to discontinuation of study drug varied from 0 to 8.8% across treatment groups and were single events spread across system organ classes. No deaths were reported in the study.

man holding glass of water
Nov 19, 2024

HUNTINGTON, NY - Sen-Jam Pharmaceutical announced recently the initiation of a Phase 2 clinical trial for SJP-001, positioning it to become the first FDA-approved therapeutic specifically targeting alcohol hangover prevention. The trial, conducted by a leading clinical research organization in Australia, marks a pivotal milestone in addressing a significant global health and productivity challenge.

SJP-001, supported by Sen-Jam's robust portfolio of 23 patents, represents a paradigm shift in understanding and treating alcohol hangover symptoms. The novel combination therapy targets the inflammatory cascade triggered by alcohol consumption, rather than focusing solely on hydration or other approaches that have shown limited efficacy.

This clinical trial is made possible through Sen-Jam's novel and inclusive funding model. By leveraging crowdfunding and the sale of Fractional Royalty Rights (FRR) on its patent portfolio, Sen-Jam has democratized investment in cutting-edge pharmaceutical innovation. The company has successfully engaged over 960 investors, 24% of whom have reinvested, demonstrating the strong community belief in the potential of SJP-001 and its mission to advance global health.

"Our FRR offering allows everyday people to directly support innovation while creating an opportunity for financial returns. It also enables us to return capital to our investors soon after licensing deals are in place," said Jim Iversen, CEO of Sen-Jam Pharmaceutical.

This funding approach ensures that Sen-Jam remains agile and focused on delivering safe, effective, and accessible therapeutics while empowering a global network of supporters to share in its success.

"Pre-clinical studies of SJP-001 have demonstrated remarkable promise in reducing both the severity and duration of morning-after symptoms," said Jackie Iversen RPh MS, Co-Founder and Chief Clinical Officer at Sen-Jam Pharmaceutical. "Our approach is grounded in cutting-edge international research that has identified inflammation as the primary driver of these alcohol related symptoms."

The therapeutic's development aligns with Sen-Jam's commitment to cellular and tissue protection against acute and chronic inflammatory responses. "This innovative solution is about promoting human health and maximizing productivity by supporting individuals who choose to consume moderate levels of alcohol. Our focus is on enhancing well-being, fostering resilience, and empowering people to thrive in both personal and professional spheres." explained Iversen.

The Center for Disease Control and Prevention (CDC) estimates that alcohol consumption costs the US $180 billion annually in lost productivity.

tablet with the words colorectal cancer
Nov 15, 2024

PRINCETON, N.J. - Bristol Myers Squibb announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo ®(nivolumab) plus Yervoy ®(ipilimumab) for the first-line treatment of adult patients with microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) unresectable or metastatic colorectal cancer (mCRC). Of significance, the CheckMate -8HW trial results showed reduction in the risk of disease progression or death by 79% (HR: 0.21; 95% CI: 0.14-0.32; p<0.0001) compared to chemotherapy in this patient population. The European Commission (EC), which has the authority to approve medicines for the European Union (EU), will now review the recommendation and make their decision.

“Approximately 5-7% of metastatic colorectal cancer patients have dMMR or MSI-H tumors, and current treatment options often do not provide sufficient benefit,” said Dana Walker, M.D., M.S.C.E., vice president, global program lead, gastrointestinal and genitourinary cancers, Bristol Myers Squibb. “This is the first dual checkpoint inhibitor treatment for first-line metastatic colorectal cancer, delivering a transformative benefit for MSI-H/dMMR patients in this population. We are focused on bringing Opdivo plus Yervoy to these patients in the European Union and look forward to EC’s upcoming decision.”

The positive opinion is based on results from the CheckMate -8HW trial, which were presented at medical congresses earlier this year. These data formed the basis for the Company’s Type II variation application, which was validated by the European Medicines Agency (EMA). In the study, Opdivo plus Yervoy demonstrated a statistically significant and clinically meaningful improvement in the dual primary endpoint of progression-free survival (PFS) compared to the investigator’s choice of chemotherapy as assessed by Blinded Independent Central Review. In addition to the risk of disease progression or death the results noted, the safety profile for the dual immunotherapy combination remained consistent with previously reported data and was manageable with established protocols, with no new safety signals identified.

In October 2024, it was announced that Opdivo plus Yervoy also demonstrated a statistically significant and clinically meaningful improvement in the dual endpoint of PFS per BICR compared to Opdivo monotherapy across all lines of therapy. The study is ongoing to assess various secondary endpoints, including overall survival (OS).

Bristol Myers Squibb thanks the patients and investigators involved in the CheckMate -8HW clinical trial.

Diabetes concept
Nov 14, 2024

INDIANAPOLIS, IN - Eli Lilly and Company announced detailed results from the Phase 3 SURMOUNT-1 three-year study (176-week treatment period), the longest completed study to date of tirzepatide. Weekly tirzepatide (Zepbound® and Mounjaro®) injections (pooled 5 mg, 10 mg, 15 mg doses) significantly reduced the risk of progression to type 2 diabetes in adults with pre-diabetes and obesity or overweight, compared with placebo, over 176 weeks. Tirzepatide demonstrated sustained average weight loss of 22.9% (15 mg dose) through the three-year treatment period for the efficacy estimand. These findings were published in The New England Journal of Medicine (NEJM) and recently presented at ObesityWeek 2024.

"Individuals treated with tirzepatide lost on average up to 23% of their body weight and maintained this for over three years, while benefitting from a substantial decrease in risk of developing type 2 diabetes. In absolute terms, nearly 99% of individuals treated with tirzepatide remained diabetes-free at 176 weeks," said Ania Jastreboff, M.D., Ph.D., director of the Yale Obesity Research Center. "These results are impressive given the degree of sustained weight reduction and decrease in risk of diabetes."

Tirzepatide is the first and only approved dual GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) receptor agonist medicine. Both GIP and GLP-1 are gut hormones secreted in response to nutrient load and are responsible for the incretin effect.

"In the SURMOUNT-1 three-year study of tirzepatide, an average weight reduction of up to 22.9% was accompanied by a hazard ratio of 0.06 for progression to type 2 diabetes. This translates to a risk reduction of 94% and a number needed to treat of nine to prevent one case of diabetes," said Jeff Emmick, M.D., Ph.D., senior vice president, product development, Lilly. "These results underscore the critical role of long-term therapy with effective treatments like tirzepatide to achieve and maintain weight reduction."  

In additional endpoints, the study showed an association of tirzepatide treatment with improvements in glycemic control, cardiometabolic risk factors (including fasting insulin, blood pressure and lipids) and health-related quality of life, which were sustained through 176 weeks. A post hoc mediation analysis suggested that approximately half of the observed effect in delay to onset of type 2 diabetes with tirzepatide was associated with medication-induced weight reduction, with the remaining benefit potentially attributed to other effects of tirzepatide.

The overall safety and tolerability profile of tirzepatide at 193 weeks (176 weeks followed by 17 weeks off-treatment) was consistent with the previously published results at 72 weeks for SURMOUNT-1 and other tirzepatide clinical studies conducted for weight reduction and long-term maintenance. Other than COVID-19, the most frequently reported adverse events were gastrointestinal-related and generally mild to moderate in severity. The most common gastrointestinal-related adverse events in patients treated with tirzepatide were nausea, diarrhea and constipation.

Bayer Logo
Nov 07, 2024

Research Triangle Park, N.C.  – Asklepios BioPharmaceutical, Inc. (AskBio), a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, today announced that AB-1003 (also known as LION-101) has received rare pediatric disease designation and orphan-drug designation from the US Food and Drug Administration (FDA) for the treatment of limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9).

FDA grants rare pediatric disease designation to incentivize the development of new treatments for serious and life-threatening diseases that primarily affect children aged 18 years or younger, with fewer than 200,000 people affected in the US. If AB-1003 is approved, AskBio may qualify for a priority review voucher based on receipt of this designation. A priority review voucher can be applied to another therapy in the company’s pipeline, enabling a shorter review timeline during marketing application review or can be sold and transferred to another company.

Orphan designation provides orphan status to drugs and biologics for rare diseases that meet certain criteria and potentially gives a company exclusive marketing rights for a seven-year period, along with other benefits.

“These designations for AB-1003 are clear recognition of the significant unmet medical need in LGMD, including type 2I/R9, which is the focus of AskBio’s clinical program and for which there is no approved therapy,” said Canwen Jiang, MD, PhD, Chief Development Officer and Chief Medical Officer, AskBio. “The burden of this rare form of muscular dystrophy on patients and their families is profound, and these decisions support our efforts to potentially bring a new therapeutic option to people living with the 2I/R9 type of this devastating disease.”

LGMD2I/R9 is a form of LGMD caused by changes in the FKRP gene and is associated with weakness and wasting of arm and leg muscles.People living with LGMD2I/R9 may notice symptoms including loss of mobility, impaired heart or lung function. These symptoms can occur in school age and younger children. As symptoms worsen, individuals generally require wheelchairs. LGMD2I/R9 is a rare disease, estimated to affect fewer than 5,000 people in the US. Currently, there is no treatment that modifies disease progression, and management is based on the signs and symptoms present in each individual.

With a broad portfolio of investigational gene therapies at various stages of research and development, AskBio continues to develop adeno-associated virus (AAV)-based therapies to treat some of the world’s most debilitating diseases. The company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular, and metabolic disease indications and aims to deliver breakthrough treatments that could potentially benefit tens of millions of patients worldwide.

hotomicrograph of bone marrow aspirate showing myeloblasts of acute myeloid leukemia (AML), a cancer of white blood cells.
Nov 01, 2024

The Food and Drug Administration granted accelerated approval to asciminib (Scemblix, Novartis AG) for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP).

The efficacy of asciminib for newly diagnosed Ph+ CML in CP was evaluated in ASC4FIRST (NCT04971226), a multicenter, randomized, active-controlled, open-label trial. A total of 405 patients were randomized (1:1) to receive either asciminib or investigator-selected tyrosine kinase inhibitors (IS-TKIs) (imatinib, nilotinib, dasatinib, or bosutinib). The main efficacy outcome measure was major molecular response (MMR) rate at 48 weeks. The MMR rate at 48 weeks was 68% (95% CI: 61, 74) in the asciminib arm and 49% (95% CI: 42, 56) in the IS-TKIs arm (difference 19% [95% CI: 10, 28], p-value <0.001). Within the imatinib stratum, the MMR rate was 69% (95% CI: 59, 78) in the asciminib arm and 40% (95% CI: 31, 50) in the IS-TKIs arm (difference 30% [95% CI: 17, 42], p-value <0.001).

In the pooled safety population in patients with newly diagnosed and previously treated Ph+ CML in CP, the most common adverse reactions (≥20%) were musculoskeletal pain, rash, fatigue, upper respiratory tract infection, headache, abdominal pain, and diarrhea. The most common laboratory abnormalities (≥40%) in patients with newly diagnosed Ph+ CML in CP were decreased lymphocyte count, decreased leukocyte count, decreased platelet count, decreased neutrophil count, and decreased calcium corrected.

The recommended asciminib dosage is 80 mg taken orally once daily at approximately the same time of day or 40 mg taken orally twice daily at approximately 12-hour intervals.

White oxy pills
Oct 29, 2024

PRINCETON, N.J - Protega Pharmaceuticals Inc. recently announced that the U.S. Food and Drug Administration (FDA) has approved ROXYBOND™ (oxycodone hydrochloride) immediate-release (IR) CII 10 mg tablet for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. ROXYBOND is the first and only FDA-approved abuse-deterrent IR 10 mg oxycodone formulation that is expected to reduce abuse by intranasal and intravenous routes.

ROXYBOND is formulated with SentryBond™ abuse-deterrent technology. This patented technology combines inactive excipients with active pharmaceutical ingredients to make the tablet more difficult to manipulate for misuse and abuse, even if it is subjected to physical manipulation and/or chemical extraction. SentryBond is designed to maintain the intended release profile of extended-release (ER) products and delay the release of IR products.

"The FDA approval of ROXYBOND 10 mg with SentryBond is a significant milestone for Protega and fulfills an unmet need for an IR opioid with abuse-deterrent technology that may reduce misuse and abuse while providing pain relief to medically appropriate patients when used as indicated," said Paul Howe, Chief Commercial Officer of Protega. "When manipulated, our innovative technology renders the pill more difficult to misuse or abuse, such as being cut or crushed to snort or inject."

Protega's SentryBond technology is a first-of-its-kind abuse-deterrent patented technology. It is designed to provide multiple levels of protection that resist physical manipulation, chemical extraction, and manipulation or transformation for injection. Protega's proprietary SentryBond technology platform could potentially be utilized in other medications to help deter misuse and abuse, e.g., hydromorphone, hydrocodone, and attention deficit hyperactivity disorder (ADHD) medications. While these uses are currently not available and require FDA approval, the technology can help in a variety of medications.

"The development of ROXYBOND with SentryBond is a step forward in fighting the national epidemic of prescription opioid overdose," said Eric Kinzler, Ph.D., VP Medical and Regulatory Affairs for Protega. "Protega is dedicated to our mission to block the path to abuse and work with healthcare professionals across the continuum of care to reduce misuse and abuse. We look forward to responsibly launching ROXYBOND 10 mg and advancing our innovative technology platform for potential application in other commonly abused prescription medications."

More than 2000 in vitro tests were conducted to demonstrate ROXYBOND tablets were difficult to manipulate vs oxycodone IR, this data, along with the results of the human abuse potential study, suggest that the physicochemical properties of ROXYBOND are expected to reduce abuse via the intranasal and intravenous routes of administration. However, abuse is still possible by intranasal, intravenous, and oral routes.

In addition to the FDA approval for the 10 mg tablet, ROXYBOND was previously approved and is already available in 5 mg, 15 mg, and 30 mg tablets. Protega plans to launch ROXYBOND 10 mg before the end of the year, providing clinicians with another risk mitigation tool they can use when treating patients with severe pain.

The addition of ROXYBOND 10 mg can enhance flexibility and precision in opioid therapy, aiming to support both physicians and patients in achieving more effective and safer pain management outcomes. For patients, the range of doses can provide better pain control, reduce the risk of side effects, and provide a smoother transition during dosing transitions. For physicians, it can allow for more flexible dosing for pain levels, better titration, and help optimize risk management across diverse patient populations.