Following the top line results from the company’s clinical phase IIa CHIC (Copenhagen Head Injury Ciclosporin) study, conducted at Rigshospitalet in Copenhagen, Denmark, and the positive results from the preclinical studies, done in collaboration with the University of Pennsylvania (Penn), USA, NeuroVive requested Scientific Advice with EMA on the continued clinical development program to bring NeuroSTAT to the market for treatment of moderate to severe TBI, including the design of the planned Phase IIb proof of concept study with NeuroSTAT.
The EMA Scientific Advice feedback is supportive of the novel design NeuroVive has proposed for its efficacy studies, including advanced imaging assessments of the protective effect of NeuroSTAT on brain cells. Furthermore, a subpopulation of the patient population will be selected with similar types of injury to the brain which facilitates evaluation of efficacy. NeuroSTAT has received orphan drug designation status (ODD) from both EMA and the U.S. Food and Drug Administration (FDA).
“The feedback from EMA is very encouraging in moving our development program forward effectively since the design of our innovative proof of concept study including the endpoints and patient population were endorsed. This will potentially be beneficial in bringing our new treatment opportunity, NeuroSTAT, to the TBI patients who need it. Moreover, the introduction of novel designs and measures may be useful in the development of other TBI clinical projects”, said Magnus Hansson, Chief Medical Officer at NeuroVive.
“The positive response from EMA is an important and valuable validation of our NeuroSTAT clinical development program, which is helpful as we will now approach FDA for formal advice”, said Erik Kinnman, CEO at NeuroVive. “We are also intensifying our efforts in forming strategic alliances and applying for supportive non-dilutive co-funding of the Phase IIb NeuroSTAT proof of concept clinical study as we continue to develop this novel treatment opportunity for patients with TBI, an area of high unmet medical need”, he continued.
This information is information that NeuroVive Pharmaceutical AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 11.30 a.m. CEST on 21 September 2017.