BIT Pharma Announces Positive Phase 2b Study Results for NicaPlant® in aneurysmal subarachnoid heamorrhage patients (aSAH) undergoing aneurysm clipping.
In a multicenter Phase 2b trial, NicaPlant® met its primary endpoint, demonstrating a statistically significant efficacy in reducing angiographic cerebral vasospasm on top of standard of care in comparison to standard of care alone.
NicaPlant® is a modified release formulation that is locally applied in the brain at the time of surgical intervention.
“There is a substantial unmet medical need for people undergoing aneurysm clipping. While the aneurysmal repair is successful in most cases, the recovery from the hemorrhage is limited. Post-hemorrhagic vasospasm is still the major concern, leading to ischemic events and associated neurological deficits that will impact long term these patients.” said Dr. Tiziana Adage, Chief Scientific Officer at BIT Pharma.
“We are excited by the NicaPlant® study results, and the potential for NicaPlant® to be a meaningful new treatment option for aSAH patients. We also believe these results support BIT Pharma’s goal of continuing to build a portfolio by bringing potential new local treatment options to people with great unmet medical need in the CNS field” said Professor Dr. Breitenbach, CEO BIT Pharma.
More results will follow.