Clinical Trial News
FDA Approves Yorvipath (palopegteriparatide) for Hypoparathyroidism
- The FDA has approved Yorvipath (palopegteriparatide) as a treatment for adults with hypoparathyroidism, offering a new therapeutic option.
- Yorvipath is developed by Ascendis Pharma using their TransCon technology, designed to provide a potentially best-in-class therapy.
- The approval follows an extension of the FDA review period to fully assess the New Drug Application (NDA) for palopegteriparatide.
- This medication aims to address the urgent need for new treatments for adults in the United States suffering from hypoparathyroidism.
Nyxoah's Genio System Shows Strong Results in DREAM Pivotal Study for Obstructive Sleep Apnea Treatment
- Nyxoah's DREAM U.S. pivotal study for its Genio system achieved co-primary endpoints with a 70.8% median reduction in Apnea-Hypopnea Index (AHI) and strong efficacy in both supine and non-supine sleep positions.
- The company is preparing its final FDA submission this quarter and anticipates potential approval by the end of 2024, positioning Genio as the only hypoglossal neurostimulation therapy demonstrating efficacy across different sleep positions.
- Nyxoah reported €1.2 million in Q1 2024 revenue, representing 170% growth compared to Q1 2023, while maintaining a cash position of €44.3 million to support commercialization efforts.
NanoViricides' NV-387 Shows Broad-Spectrum Antiviral Activity Against 'Tripledemic' Viruses and Smallpox in Animal Models
- NanoViricides' NV-387 demonstrates strong antiviral activity against coronaviruses, RSV, and influenza A viruses, including H5N1 in animal studies.
- NV-387 outperformed approved anti-influenza drugs like Oseltamivir in a lethal influenza A/H3N2 lung infection model, showing superior antiviral effects.
- The antiviral agent also proved effective against orthopoxviruses, including Smallpox and Mpox, increasing lifespan in a lethal animal model comparable to tecovirimat.
- Phase 1 clinical trials of NV-387 in healthy subjects showed no adverse events, paving the way for Phase 2 trials focusing on RSV infections.
SNB-101 Receives FDA Fast Track Designation for Small Cell Lung Cancer
- SNB-101, a novel polymer nanoparticle formulation of SN-38, has been granted Fast Track designation by the FDA for the treatment of small cell lung cancer (SCLC).
- Early clinical data suggests SNB-101 improves tolerability and exhibits lung-specific efficacy compared to traditional anticancer agents in SCLC patients.
- SNB-101 leverages SN Bioscience's dual nano-micelle technology to deliver the active metabolite of irinotecan, SN-38, directly to lung cancer cells.
- Global phase 2 clinical trials are anticipated to begin in the second half of 2024, with potential expansion to other solid tumors like colon and gastric cancer.
Highlighted Clinical Trials:
SN BioScience
Posted 6/21/2024
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.
AI-Powered Tool 'Petrushka' Personalizes Antidepressant Treatment in Oxford University Trial
- Oxford University is conducting a clinical trial using 'Petrushka,' an AI tool, to personalize antidepressant treatment for individuals with depression.
- Petrushka analyzes data from over a million people, factoring in age, gender, and symptom severity to recommend the most effective antidepressants in real-time.
- The trial, involving over 500 participants across multiple countries, aims to improve treatment outcomes by tailoring prescriptions to individual patient characteristics.
- Researchers hope Petrushka will reduce the trial-and-error approach to antidepressant prescriptions, leading to more effective and sustainable treatments.
UroGen Pharma's UGN-102 Shows Promise in Bladder Cancer Treatment
- UroGen Pharma's UGN-102, combined with TURBT, demonstrates high probabilities of remaining event-free for disease-free survival in LG-IR-NMIBC patients.
- The company plans to complete the NDA submission for UGN-102 in Q3 2024, with potential FDA decision as early as Q1 2025.
- Jelmyto shows favorable recurrence-free survival rates for LG-UTUC patients, with 75% showing no disease recurrence in a 5-year rollover trial.
- UroGen's next-generation mitomycin-based formulation, UGN-103, receives FDA IND acceptance, with Phase 3 studies planned for LG-IR-NMIBC.
Moleculin Reports First Quarter 2024 Financial Results and Corporate Update
Moleculin Biotech, Inc. announced its first quarter 2024 financial results, highlighting significant progress in its clinical trials for AML treatment, including promising interim data from the MB-106 study. The company also discussed its financial health and upcoming milestones.
Highlighted Clinical Trials:
Moleculin Biotech, Inc.
Posted 9/29/2022
Merck Discontinues Vibostolimab/Pembrolizumab Arm in Phase 3 Melanoma Trial
- Merck halted the vibostolimab and pembrolizumab coformulation arm of the Phase 3 KeyVibe-010 trial due to futility in meeting the primary endpoint of recurrence-free survival (RFS).
- The independent Data Monitoring Committee (DMC) recommended unblinding the study and offering KEYTRUDA monotherapy to patients in the coformulation arm.
- Merck will continue to evaluate the vibostolimab and pembrolizumab coformulation in lung cancer trials, with no anticipated changes based on the KeyVibe-010 findings.
- The ongoing Phase 3 V940-001 study, in collaboration with Moderna, evaluating V940 (mRNA-4157) in combination with KEYTRUDA as adjuvant treatment in resected high-risk melanoma patients, remains active.
Highlighted Clinical Trials:
Merck Sharp & Dohme LLC
Posted 1/19/2023