Clinical Trial News

An NIH study revealed that Siga Technologies' antiviral drug, tecovirimat, did not enhance lesion resolution time or alleviate pain in adults with mild to moderate clade II mpox and low risk of severe disease. The study's Data Safety and Monitoring Board recommended halting further enrollment due to these findings, leading to the closure of an open-label study arm for participants at elevated risk of severe disease.

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for GSK's GSK'227, a B7-H3-targeted antibody-drug conjugate, for treating relapsed or refractory osteosarcoma in adults. This decision is based on promising data from the ARTEMIS-002 study, highlighting the drug's potential in addressing a significant unmet medical need.

Zealand Pharma has enrolled the first participant in its ZUPREME-1 Phase 2b trial, focusing on the effects of petrelintide on body weight, safety, and tolerability in individuals with obesity or overweight and weight-related co-morbidities.

NeuroSense Therapeutics has entered into a binding term sheet with a leading global pharmaceutical company to advance the development and commercialization of PrimeC, its proprietary treatment for amyotrophic lateral sclerosis (ALS), in key territories. The agreement includes substantial financial terms and retains NeuroSense's full rights to PrimeC in other territories.

Vir Biotechnology has announced that its drugs, tobevibart and elebsiran, have been granted Breakthrough Therapy designation by the FDA and Priority Medicines designation by the EMA for treating chronic hepatitis delta (CHD). This decision is backed by positive safety and efficacy data from the Phase 2 SOLSTICE trial. The Phase 3 ECLIPSE registrational program is set to begin in the first half of 2025, aiming to provide a much-needed treatment option for CHD, a severe form of chronic viral hepatitis with no approved treatment in the U.S. and limited options globally.

Genentech's Phase IIb study on Prasinezumab for early-stage Parkinson's disease did not meet its primary endpoint, but indicated potential benefits with a numerical delay in motor progression and positive trends on secondary endpoints.

A single-centre, randomised controlled feasibility pilot trial aimed to determine the feasibility for a larger definitive trial on first-pass intubation success rates. The study revealed an overall first-pass success rate of 78%, suggesting that a larger trial assessing a robust endpoint of first-pass success is feasible. The trial compared video laryngoscopy (VL) and direct laryngoscopy (DL), highlighting the need for further research to assess the effectiveness and potential biases of these techniques.

SpecGx LLC received a Complete Response Letter from the FDA regarding its NDA for an abuse-deterrent, immediate-release reformulation of Roxicodone. The FDA requested further evaluation for potential approval. SpecGx plans to discuss the FDA's guidance and continues efforts to mitigate opioid abuse through technology and community programs.

Fox Chase Cancer Center's RETAIN Bladder study explores active surveillance over bladder removal for MIBC patients post-chemotherapy, using genetic mutations and clinical features to predict treatment success. Aiming to preserve quality of life, the study identifies patients who may avoid cystectomy, with ongoing research into biomarkers and treatment efficacy.

In the LYM-3002 study, VR-CAP showed significantly longer median overall survival (90.7 months) compared to R-CHOP (55.7 months) in untreated mantle cell lymphoma patients, with a manageable safety profile. Results support further VR-CAP assessment.