BIT Pharma’s Nicaplant® implants, licensed in Spain by Laboratorios Gebro Pharma, achieve the EMA’s PRIME designation

• Laboratorios Gebro Pharma, S.A. and the Austrian biotech company BIT Pharma signed an agreement in May 2022. The product is intended to prevent cerebral vasospasm, a complication in patients operated on due to subarachnoid hemorrhage.

• The results of the phase 2b clinical trial within the clinical development of the drug, recently presented to the scientific community, made it possible for the European Medicines Agency (EMA) to grant it the PRIME designation in October 2022

Laboratorios Gebro Pharma, S.A. and BIT Pharma signed an agreement back in 2022 for the commercialization of Nicaplant® in Spain, subject to prior regulatory approval. The implants, currently in development, are intended to prevent cerebral vasospasm, a severe complication that occurs in a high percentage of patients who have suffered a subarachnoid hemorrhage. This type of bleeding can be caused, among other factors, by the rupture of an aneurysm. The drug would be indicated for the prevention of vasospasms caused by this type of bleeding.

BIT Pharma is a biotech company based in Austria, country in which the pharmaceutical group Gebro Pharma GmbH is also based and specializes in the development of new products for diseases affecting the Central Nervous System. The product is an intracerebral implant of nicardipine that is placed in the patient at the time of surgery to close the bleeding.

The phase 2b clinical trial of Nicaplant® ended in May 2022 and its results have been presented to the scientific community at various international congresses and more recently, in May 2023 in Santander, at the XXVI Congress of the Spanish Society of Neurosurgery & Intermediate Meeting of the Latin American Federation of Neurosurgery Societies (SENEC / FLANC 2023).

This clinical trial demonstrated a significant reduction, greater than 30%, in the incidence of cerebral vasospasm in patients treated with Nicaplant® compared to the control group treated with standard treatment alone. Additionally, the intracerebral implant of nicardipine was shown to have a good safety profile.

Thanks to the promising results of this trial, the drug obtained the PRIME designation from the European Medicines Agency in October 2022. PRIME is a programme of the European Medicines Agency (EMA) aimed at accelerating the development of medicines that cover needs not covered by treatments. This program allows them to receive greater scientific support and be eligible for accelerated evaluation. In this way they can reach patients as soon as possible.

The presentation of the results at the SENEC/FLANC 2023 Congress was carried out by Dr. Lars Wessels, neurosurgeon at Charité – Universitätsmedizin Berlin and co-author of the phase 2 trial.

As stated by Dr. Wessels, “the phase II clinical trial results have been very interesting because they represent a crucial step in our ongoing research. The significant reduction in cerebral vasospasm after aneurysmatic subarachnoid hemorrhage exhibits great promise for improving clinical situations for patients suffering from SAH. It is heartening to see such optimistic outcomes emerging from this phase of the study. While we recognize there is much work yet to be done, it is encouraging to note the progress we have made thus far. Based on the promising results we’ve observed in this Phase 2b study, we hope to confirm the results in the phase 3trial.”

At the moment our partner BIT Pharma is being advised by the EMA for the design of the phase 3 trial. Its results, if positive, will allow the authorization for the commercialization of the product in Europe.

In the words of Ivet Vall, Director of Business Development & Innovation at Gebro Pharma, «our agreement with BIT Pharma reinforces our constant commitment to Innovation and also makes us especially excited because it is a drug designated orphan by the EMA, since the pathology indicated for Nicaplant® affects few people. So far, current treatments do not always offer the desired efficacy for the prevention of vasospasm after a subarachnoid hemorrhage. That is why we hope to contribute to improving the health and quality of life of these patients with a new alternative«.

In line with the previous statements Tiziana Adage, Chief Scientific Officer at BIT Pharma, expresses that “There is still a substantial unmet medical need for patient with aneurysmal subarachnoid haemorrhage. While the aneurysmal repair is successful in most cases, post-haemorrhagic vasospasm is still the major concern, leading to ischemic events and associated neurological deficits that will impact long term these patients. The results of the phase 2 study with NicaPlant are very promising, as reflected by the PRIME designation”.

Vasospasm and subarachnoid hemorrhage

Subarachnoid hemorrhage (SAH) is a rare type of stroke, but with significant morbidity and mortality and social and health burden since it can also occur in apparently healthy and young patients. The incidence in Spain is similar to that of the rest of Europe, and is estimated at about 9 cases per 100,000 inhabitants per year. SAH of aneurysmal origin has a mortality of 26% according to studies, and 85% of cases receive treatment in the first 72 hours. Vasospasm is one of the main complications that are to be avoided in patients who have been operated on because of an SAH, although unfortunately current treatments do not show the desired effectiveness. Therefore, the development of new effective treatments to prevent vasospasm is a clinical unmet need.