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Introduction

Brain Implant Therapeutics (BIT) Pharma was founded in November 2015 by leaders from academia and industry, based on the acquisition of intellectual property. BIT Pharma develops and commercialise technologies for site-specific drug delivery to the central nervous system (CNS), in particular the brain, exploiting tailored drug delivery systems.

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Nervous System Diseases

Cardiovascular Diseases

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Disease Domain	Count

Nervous System Diseases	1

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Unknown	1

This study of NicaPlant® is conducted in patients who have a subarachnoid haemorrhage. Patients will be randomized in two treatment groups. Both groups will receive the standard of care and the investigational group will receive in addition NicaPlant®. NicaPlant® is tested to reduce the long-term complications of aneurysmal subarachnoid haemorrhage (aSAH).

Start Date05 Apr 2020

Sponsor / Collaborator

BIT Pharma GmbH

[+3]

EUCTR2016-004521-17-AT / Not yet recruitingPhase 2

A Phase IIa: single ascending dose safety, tolerability and pharmacokinetic study of NicaPlant® in aneurysmal subarachnoid haemorrhage patients undergoing aneurysm clipping

Start Date19 Feb 2018

Sponsor / Collaborator

BIT Pharma GmbH

100 Clinical Results associated with BIT Pharma GmbH

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0 Patents (Medical) associated with BIT Pharma GmbH

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2

Literatures (Medical) associated with BIT Pharma GmbH

01 Jan 2023·Brain and Spine

A randomized, single ascending dose safety, tolerability and pharmacokinetics study of NicaPlant® in aneurysmal subarachnoid hemorrhage patients undergoing clipping

Article

Author: Wolf, Stefan ; Gmeiner, Matthias ; Vajkoczy, Peter ; Gruber, Andreas ; Kerschbaumer, Johannes ; Petr, Ondra ; Gollwitzer, Maria ; Stefanits, Harald ; Freyschlag, Christian Franz ; Gempt, Jens ; Meyer, Bernhard ; Bendszus M, Martin ; Breitenbach J, Joerg ; Hecht, Nils ; Thomé, Claudius ; Adage, Tiziana ; Wostrack, Maria ; Wessels, Lars

IntroductionAneurysmal subarachnoid hemorrhage (aSAH) is associated with high morbidity and mortality. Post-hemorrhagic vasospasm with neurological deterioration is a major concern in this context. NicaPlant®, a modified release formulation of the calcium channel blocker nicardipine, has shown vasodilator efficacy preclinically and a similar formulation known as NPRI has shown anti-vasospasm activity in aSAH patients under compassionate use.Research questionThe study aimed to assess pharmacokinetics and pharmacodynamics of NicaPlant® pellets to prevent vasospasm after clip ligation in aSAH.Material and methodsIn this multicenter, controlled, randomized, dose escalation trial we assessed the safety and tolerability of NicaPlant®. aSAH patients treated by clipping were randomized to receive up to 13 NicaPlant® implants, similarly to the dose of NPRIs previous used, or standard of care treatment.ResultsTen patients across four dose groups were treated with NicaPlant® (3-13 implants) while four patients received standard of care. 45 non-serious and 13 serious adverse events were reported, 4 non-serious adverse events and 5 serious adverse events assessed a probable or possible causal relationship to the investigational medical product. Across the NicaPlant® groups there was 1 case of moderate vasospasm, while in the standard of care group there were 2 cases of severe vasospasm.Discussion and conclusionThe placement of NicaPlant® during clip ligation of a ruptured cerebral aneurysm raised no safety concern. The dose of 10 NicaPlant® implants was selected for further clinical studies.

BiomoleculesQ3 · BIOLOGY

Cytokines and Chemokines in SARS-CoV-2 Infections—Therapeutic Strategies Targeting Cytokine Storm

Q3 · BIOLOGY

ReviewOA

Author: Kungl, Andreas J. ; Adage, Tiziana ; Pum, Alexandra ; Ennemoser, Maria

The recently identified severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus, the cause of coronavirus disease (COVID-19) and the associated ongoing pandemic, frequently leads to severe respiratory distress syndrome and pneumonia with fatal consequences. Although several factors of this infection and its consequences are not completely clear, the presence and involvement of specific chemokines is undoubtedly crucial for the development and progression of COVID-19. Cytokine storm and the often-resulting cytokine release syndrome (CRS) are pathophysiological hallmarks in COVID-19 infections related to its most severe and fatal cases. In this hyperinflammatory event, chemokines and other cytokines are highly upregulated and are therefore not fulfilling their beneficial function in the host response anymore but causing harmful effects. Here, we present the recent views on the involvement of chemokines and selected cytokines in COVID-19 and the therapeutics currently in clinical development targeting or interfering with them, discussing their potentials in the treatment of COVID-19 infections.

100 Deals associated with BIT Pharma GmbH

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100 Translational Medicine associated with BIT Pharma GmbH

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Pipeline

Pipeline Snapshot as of 07 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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