Graz, Austria, October 19th, 2022 – BIT Pharma GmbH today announced that the European Medicines Agency (EMA) has granted access to the Priority Medicines (PRIME) scheme for NicaPlant®, a novel, modified release implant for the treatment of non-traumatic subarachnoid haemorrhage in patients undergoing surgery.
PRIME is a program launched by the EMA to enhance support for the development of medicines that target an unmet medical need. This voluntary program is based on enhanced interaction and early dialogue with developers of promising medicines and is designed to optimize development plans and speed up evaluation so these medicines can potentially reach patients earlier. According to the EMA, developers of medicines that are eligible for PRIME can expect additional opportunities for scientific advice and be eligible for accelerated assessment at the time of application for a marketing authorization.
NicaPlant® was designated as an orphan medicine by EMA during its development already in 2019.
“Promising results from non-clinical data and the Phase 2 a and b safety, tolerability and efficacy in patients formed the basis of the application for PRIME eligibility. We are pleased with the EMA’s decision to grant PRIME eligibility to NicaPlant®. We look forward to applying the benefits available to us through PRIME as we continue to advance our program,” said Dr. Tiziana Adage, chief scientific officer of BIT Pharma.
Aneurysmal subarachnoid haemorrhage (aSAH), representing up to 98.9% of all non-traumatic subarachnoid haemorrhage cases, has high mortality rates for patients (>40%), high disability among survivors with 30% after 3 months and only 60% of survivors currently resume their previous lifestyle after 6 months, with life-long costs for the healthcare system and burden for the patients and their families.
In a Phase 2a clinical trial in patients, NicaPlant® was safe and well tolerated at all doses studied. A Phase 2b clinical trial assessed the efficacy of NicaPlant® on the incidence of cerebral angiographic vasospasm following aneurysmal Subarachnoid Haemorrhage (aSAH). NicaPlant® implants raised no safety concerns and, amongst other positive outcomes, had a significant positive effect on reducing the incidence of vasospasms and the need of anti-vasospasm rescue therapy.
About BIT Pharma GmbH
BIT Pharma discovers and develops novel technologies for site-specific drug delivery to the Central Nervous System, in particular the brain, exploiting tailored drug delivery systems. Medicines that treat rare diseases in which significant unmet medical needs exist are a key focus area. BIT Pharma’s technology (AIMEX®) is based on proprietary manufacturing process for tailored drug release at the site of action. BIT Pharma has several ongoing development programs including oncology, pain and neurodegenerative applications using its NoSys® platform. For more information, please visit the company’s website at www.bit-pharma.com.
