Collaboration in the Development of a New Product – NicaPlant® – for the Treatment of Non-Traumatic Subarachnoid Hemorrhage

Summary

In 2022 Laboratorios Gebro Pharma, S.A. and BIT Pharma signed an agreement for the commercialization of NicaPlant® in Spain. NicaPlant® is an implant currently in clinical development designed to prevent cerebral vasospasm, a severe complication that occurs in a significant percentage of patients who have experienced non-traumatic subarachnoid hemorrhage.

The phase 2b clinical trial of NicaPlant® concluded in May 2022. This trial demonstrated a significant reduction, exceeding 30%, in the incidence of cerebral vasospasms in patients treated with NicaPlant® compared to the control group receiving standard treatment alone. Additionally, NicaPlant® exhibited a favorable safety profile.

Thanks to the promising results of this trial, NicaPlant® obtained the PRIME designation from the European Medicines Agency in October 2022. PRIME is a program by the European Medicines Agency (EMA) aimed at expediting the development of medications addressing unmet medical needs. Currently, the phase III clinical trial is being designed with guidance from the EMA.

Collaborating entities

BIT Pharma

Duration

Agreement signed in 2022