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Clinical Trial News

FDA Accepts Sumitomo Pharma's sNDA for Vibegron in Men with OAB and BPH

  • The FDA has accepted Sumitomo Pharma's sNDA for vibegron (GEMTESA) to treat OAB symptoms in men receiving BPH pharmacological therapy.
  • The sNDA is based on Phase 3 trial results showing statistically significant reductions in daily micturition and urgency episodes with vibegron.
  • If approved, vibegron will be the first beta-3 agonist for OAB in men undergoing BPH treatment, addressing a significant unmet need.
  • The FDA's target action date for the decision on vibegron's approval is set for Q3 of FY2024 under the PDUFA.

Wegovy's SELECT Trial: Sustained Weight Loss and Heart Benefits Beyond Weight Reduction

  • Wegovy demonstrates sustained weight loss of 10% over four years in individuals with existing cardiovascular risk, according to new analyses from the SELECT trial.
  • The SELECT trial indicates that Wegovy's cardiovascular benefits, including a 20% reduction in heart attack, stroke, or heart-related death, may extend beyond weight loss alone.
  • No new safety concerns were identified in the four-year analysis, with previously known gastrointestinal side effects being the most common reason for trial discontinuation.
  • Experts suggest the SELECT trial results may warrant a re-evaluation of insurance coverage criteria for Wegovy, considering its potential heart-health benefits irrespective of weight loss.

Kite and Arcellx to Initiate Phase III Trial of Anito-Cel for Multiple Myeloma

• Kite and Arcellx are set to begin a Phase III clinical trial, iMMagine-3, to evaluate anito-cel for relapsed/refractory multiple myeloma. • The global study will enroll approximately 450 adults who have undergone one to three prior treatments for RRMM. • Anito-cel, a BCMA-targeted CAR-T cell therapy, will be compared against the standard of care, with progression-free survival as the primary endpoint. • Kite's facility in Frederick, Maryland, will produce anito-cel for the trial, marking a significant milestone in the therapy's development.

Agenus Highlights Progress of BOT/BAL Program in Q1 2024, Secures $100 Million Royalty Financing

  • Agenus secured a $100 million royalty financing agreement with Ligand Pharmaceuticals to advance the BOT/BAL program, including a Phase 3 study in relapsed/refractory MSS CRC.
  • Botensilimab combined with balstilimab demonstrates deep, durable responses in poorly immunogenic solid tumors, with a 23% overall response rate and 21.2 months median overall survival in relapsed/refractory CRC patients.
  • Agenus plans to submit a BLA for BOT/BAL by the end of the year, supported by Phase 2 trial data and real-world evidence, and anticipates an FDA meeting in July 2024.
  • Investigator-sponsored trials are ongoing to evaluate BOT/BAL in earlier lines of therapy for colorectal cancer and other malignancies, showing promising results in neoadjuvant settings.

Kymera Therapeutics Highlights Clinical Progress and Financial Strength in Q1 2024

  • Kymera Therapeutics reported $10.3 million in revenue, primarily from its collaboration with Sanofi, and holds a strong cash balance of $745 million, expected to last into the first half of 2027.
  • The company is advancing its first-in-class oral IRAK-4 degrader, KT-474, into Phase 2 trials, showcasing promising early clinical data in immunology and oncology.
  • Kymera plans to present an update on its MDM2 program at ASCO, focusing on patient enrollment, safety data, pharmacodynamic effects, and clinical response data in solid tumors and hematologic malignancies.
  • Management emphasizes the potential of IRAK4 degraders to offer both efficacy and improved safety profiles compared to other oral agents like JAK or BTK inhibitors.

Eli Lilly's Efsitora Alfa Shows Promise in Type 2 Diabetes Treatment

  • Eli Lilly's efsitora alfa, a once-weekly insulin, demonstrated non-inferiority to daily insulin in Phase 3 trials for type 2 diabetes, meeting its primary endpoint.
  • The safety profile of efsitora alfa was consistent with daily insulin, suggesting it could be a viable option for patients seeking less frequent dosing.
  • Efsitora alfa aims to compete with Novo Nordisk's once-weekly insulin, Awiqli, in the growing market for diabetes treatments, addressing a significant patient population.
  • Despite competition, efsitora alfa represents a potential revenue stream for Eli Lilly, complementing its already strong portfolio and pipeline, including drugs like Verzenio and Mounjaro.

RAPT Therapeutics Halts Zelnecirnon Trials in Atopic Dermatitis and Asthma Following FDA Clinical Hold

• RAPT Therapeutics has decided to close and unblind its Phase 2b trial of zelnecirnon in atopic dermatitis and its Phase 2a trial in asthma after an FDA clinical hold. • The clinical hold was initiated due to a serious adverse event of liver failure requiring a transplant in one patient during the atopic dermatitis trial. • RAPT Therapeutics plans to analyze the data collected from the trials, even if not statistically significant, to inform future steps and discussions with the FDA. • The company's first-quarter net loss of 2024 was $30.5 million, and as of March 31, 2024, it held $141.6 million in cash and cash equivalents.

RAPT Therapeutics Reports Q1 2024 Financial Results and Clinical Trial Update

• RAPT Therapeutics reported a net loss of $30.5 million for Q1 2024, aligning with analyst estimates, while EPS was slightly better than expected at -$0.79. • Research and development expenses decreased to $24.8 million, while general and administrative expenses increased to $7.7 million due to higher personnel and consulting costs. • The company's Phase 2b and 2a clinical trials for zelnecirnon were halted due to a serious adverse event, with data analysis expected in Q3 2024. • RAPT maintains a strong cash position with $141.6 million in cash and marketable securities, supporting ongoing research and strategic initiatives despite clinical setbacks.

FibroGen Highlights Pamrevlumab's Potential in Pancreatic Cancer and Roxadustat's Growth in Q1 2024 Earnings Call

  • FibroGen anticipates top-line data from Phase 3 trials of pamrevlumab in metastatic and locally-advanced pancreatic cancer, addressing a significant unmet need.
  • Roxadustat sales in China increased by 24% year-over-year, driven by a 39% volume increase, with potential for further growth pending approval for chemotherapy-induced anemia.
  • FG-3246, a first-in-class ADC, shows promising Phase 1 results in metastatic castration-resistant prostate cancer, with plans for a Phase 2/3 study in late 2024.
  • FibroGen's strong cash position of $214.7 million is expected to fund operations into 2026, supporting the advancement of its clinical programs.

Vertex Pharmaceuticals Reports Strong Q1 2024 Performance, Advances Pipeline

• Vertex Pharmaceuticals reported a 13% revenue increase in Q1 2024, reaching $2.7 billion, driven by cystic fibrosis (CF) drug sales and the launch of CASGEVY for sickle cell disease and beta-thalassemia. • The company completed regulatory submissions in the U.S. and EU for its vanzacaftor triple therapy for CF patients aged 6 years and older, potentially setting a new standard in CF treatment. • Vertex is advancing suzetrigine (VX-548) for acute and neuropathic pain, with a rolling NDA submission underway and Phase III trials planned for painful diabetic peripheral neuropathy (DPN). • The acquisition of Alpine Immune Sciences is expected to close this quarter, adding povetacicept (pove), a Phase III-ready molecule for IgA nephropathy (IgAN), to Vertex's portfolio.

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