Clinical Trial News

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.

Ionis Pharmaceuticals announced the FDA's acceptance of the New Drug Application for donidalorsen, aimed at preventing hereditary angioedema attacks in patients 12 years and older, with a decision expected by August 21, 2025.

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.

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.

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.

A clinical trial is investigating the effectiveness of elinzanetant, a new treatment for vasomotor symptoms (VMS) or hot flashes in women with or at high risk for hormone-receptor positive breast cancer. The study aims to compare the efficacy and safety of elinzanetant against a placebo, with participants recording their symptoms and undergoing various health checks over a 62-week period.

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.