NeuroVive Pharmaceutical AB (ST:NVP) has made progress on multiple fronts over the past few months with both its core asset portfolio and non-core projects for out-licensing. Notable developments in the core portfolio include positive feedback from the EMA on the next Phase IIb trial with NeuroSTAT (traumatic brain injury, TBI) and orphan drug designation for KL1333 (genetic mitochondrial diseases) in Europe. Also, the lead compound has been selected in the NVP015 programme for genetic mitochondrial diseases with complex I dysfunction. In addition, investors had a first glimpse of the preclinical data on NVP022, which, together with NV556, targets NASH and both are in portfolio for out-licensing. Our valuation is SEK1.38bn or SEK26.3/share (vs SEK27.0/share previously).
Developing Phase IIb design for NeuroSTAT
NeuroVive has recently received positive EMA feedback on the design of the upcoming Phase IIb study with NeuroSTAT. In our view, the design of a trial involving brain trauma patients is somewhat unique, as TBIs tend to be very diverse in presentation. The challenge here is to select relevant patient subpopulation, as homogenous as possible, to capture NeuroSTAT’s efficacy, while at the same time reflecting real world practice. NeuroVive has been working on inclusion criteria and end points to evaluate NeuroSTAT’s efficacy in improving TBI outcomes. Feedback from both the EMA and the FDA is crucial in this setting, in our view. The recently announced collaboration with the University of Florida to develop biofluid-based biomarkers in TBI should also add to robustness to the clinical trial design.
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