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Clinical Trial News

NIH Study Finds Siga's Tecovirimat Did Not Improve Mpox Resolution or Pain

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.

Vir Biotechnology's Tobevibart and Elebsiran Receive FDA and EMA Designations for Chronic Hepatitis Delta Treatment

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.

FDA Grants Breakthrough Therapy Designation for GSK's Osteosarcoma Treatment

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.

NeuroSense Advances ALS Treatment with PrimeC Through Strategic Partnership

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.

FDA Grants RMAT Designation To Mesoblast's Revascor for Pediatric Hypoplastic Left Heart Syndrome

The U.S. Food and Drug Administration has granted Mesoblast Limited's Revascor (rexlemestrocel-L) the Regenerative Medicine Advanced Therapy (RMAT) designation for treating children with hypoplastic left heart syndrome (HLHS), following results from a randomized controlled trial. This designation highlights the therapy's potential in addressing this serious congenital heart condition.

HyBryte™: A Promising Photodynamic Therapy for Cutaneous T-Cell Lymphoma (CTCL)

HyBryte™, a photodynamic therapy using synthetic hypericin and visible fluorescent light, shows promise as a safe and effective treatment for Cutaneous T-Cell Lymphoma (CTCL), particularly in early-stage disease. With no FDA-approved first-line therapy for CTCL, HyBryte™ aims to reduce disease progression and toxic side effects, offering a new hope for approximately 20,000 patients in the US affected by this chronic condition.

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