DUBLIN – Ronopterin (VAS-203) failed to meet the primary endpoint of a phase III trial in traumatic brain injury (TBI), but developer Vasopharm GmbH is nevertheless convinced that it has an active drug on its hands. It has also received backing from the study’s data monitoring committee, which has provided, Vasopharm said, a “positive benefit-risk assessment” on the basis of the efficacy signals detected and the drug’s known safety profile.
Novartis AG is closing in on a label expansion for its blockbuster inflammatory disease drug, Cosentyx (secukinumab), after announcing supportive phase III results in children with two subtypes of juvenile idiopathic arthritis (JIA).
Protalix Biotherapeutics Inc. saw shares dip after releasing initial top-line data from an interim analysis of the phase III Balance clinical trial of pegunigalsidase alfa (PRX-102) to treat Fabry disease. The 24-month, randomized, double-blind, active control study is evaluating the safety and efficacy of 1 mg/kg of PRX-102 dosed every two weeks compared to agalsidase beta (Fabrazyme). Two of the study’s 78 patients dropped out because of treatment emergent adverse events and one left because of a related adverse event.
Interim findings that Sanofi SA's venglustat is unlikely to provide a meaningful benefit to people with autosomal dominant polycystic kidney disease (ADPKD) have caused the company to halt a phase II/III study of the candidate. Testing continues in other rare diseases, but the exit could be a boon for Otsuka Pharmaceutical Co. Ltd.'s Jynarque (tolvaptan), its generic competitors and ascendant novel ADPKD programs still underway.
Trading in shares in AB Science SA was suspended Tuesday after a safety signal prompted a voluntary hold on two late-stage clinical studies of its masitinib, in mastocytosis and amyotrophic lateral sclerosis, respectively.
DUBLIN – Shares in Santhera Pharmaceuticals Holding AG surged by as much as 71% June 1 on news that the high-dose arm of a phase IIb pivotal trial of vamorolone hit the primary endpoint of an improvement vs. placebo in the time-to-stand velocity attained by ambulatory boys with Duchenne muscular dystrophy (DMD).
HONG KONG – In the midst of a COVID-19 crisis, India has waived the need for “well-established” foreign vaccines to undergo local trials. That could open doors for vaccines by Pfizer Inc., Johnson & Johnson and Moderna Inc.
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