Findings from pivotal nipocalimab Phase 3 study in a broad antibody positive population of people living with generalised myasthenia gravis published in The Lancet Neurology
- Nipocalimab, an investigational FcRn blocker, showed sustained disease control over 24 weeks in antibody-positive gMG patients.
- The Phase 3 Vivacity-MG3 study met its primary endpoint with significant improvement in MG-ADL scores.
- Nipocalimab demonstrated a 75% reduction in autoantibody levels, maintaining a tolerable safety profile.
- The therapy has been granted U.S. FDA Priority Review, with applications submitted to the EMA and FDA.
Read more
Segal Trials leads phase 2 schizophrenia trial of LB-102 toward primary endpoint
- Segal Trials participated in a Phase 2 trial for LB-102, a potential first-in-class benzamide antipsychotic for acute schizophrenia.
- The trial met its primary endpoint, showing LB-102 to be efficacious, safe, and well-tolerated over a 4-week treatment period.
- Segal Trials contributed significantly to the trial's enrollment, exceeding their contracted goal by 147%.
- LB Pharmaceuticals plans to engage with the FDA to finalize Phase 3 trial design by early 2026.
Read more
Tris Pharma announces positive results from ALLEVIATE-1 phase 3 trial of cebranopadol
- Tris Pharma reported positive topline results from the ALLEVIATE-1 Phase 3 trial for cebranopadol, targeting moderate-to-severe acute pain post-abdominoplasty.
- Cebranopadol, a dual-NMR agonist, showed significant pain reduction compared to placebo, with a favorable safety profile and no serious adverse events.
- The trial demonstrated a statistically significant reduction in pain intensity using the Pain Numeric Rating Scale (NRS) over 44 hours post-surgery.
- Tris plans to present full results at a medical congress and expects an NDA submission later this year, with further studies planned for chronic pain indications.
Read more
Tiziana Life Sciences discovers new immune biomarkers in MS patients treated with nasal foralumab
- Tiziana Life Sciences identified new immune biomarkers in non-active secondary progressive multiple sclerosis (na-SPMS) patients treated with nasal foralumab.
- The study revealed gene expression changes in T regulatory cells, central memory T cells, and monocytes, indicating modulation of immune pathways.
- Single-cell RNA sequencing showed reduced microglial brain inflammation, supporting the drug's biological effects.
- The findings will be submitted to a peer-reviewed journal and may guide future clinical trials and treatment strategies.
Read more
