BIT PHARMA ANNOUNCES SUCCESSFUL COMPLETION OF NicaPlant PHASE IIa CLINICAL TRIAL
Graz (Austria), 6th July 2019 – The Specialty Pharma Company BIT PHARMA today announces the successful completion of their Phase IIa trial assessing the safety and tolerability of ascending doses of BIT PHARMA’s lead product NicaPlant®.
The Phase IIa trial was a multicentre, single-blind, randomized clinical trial evaluating the efficacy and safety of NicaPlant® in patients with aneurysm subarachnoid haemorrhage.
The trial was conducted in four medical facilities in Germany and Austria. Randomized in two groups, one was administered with ascending doses of NicaPlant®, while the other was on standard of care. The trial data confirmed the safety and tolerability profile of NicaPlant® and reveal a high chance for efficacy.
Following this successful completion of the Phase IIa clinical trial, BIT Pharma plans to start a Phase IIb trial still in 2019.
Dr. Karl Maier, CEO of BIT Pharma, commented: “We congratulate our team on the successful completion of the Phase IIa clinical trial. The study further increases our believe that NicaPlant® represents a true benefit for patients with aneurysm subarachnoid haemorrhage.”
“We are inspired by the results of this Phase IIa clinical trial. The research, conducted at multiple sites, paves the way to the next study.” Medical Advisor of BIT Pharma Professor Dr Schmiedek said.
Professor Dr P. Vajkoczy presented the results at the investigator’s meeting in Vienna.
BIT Pharma contact: Dr T. Adage, scientific director, Tiziana.Adage@bit-pharma.com