Research & Drug Development

Newron is developing ralfinamide, a novel well-tolerated small molecule for the treatment of neuropathic pain.

Ralfinamide is a unique New Chemical Entity that is believed to mediate its potent analgesic effect through the inhibition of sodium channels, including Nav 1.7,  N-type Calcium channels and NMDA receptor.

Ralfinamide recently completed a phase IIb/III study in patients with Newuropathic Low Back Pain (NLBP). The top-line results, which continued to show that the compound was safe and well-tolerated, demonstrated no statistical significance in efficacy against placebo. This outcome is in contradiction to results that had previously been achieved in a phase II study in mixed neuropathic pain, including NLBP patients. All associated work on the SERENA trial and its extension have been halted. In the meantime, a scientific advisory board has met and recommended that ralfinamide is further developed in another indication, based on their view that its pharmacology is extremely exciting and predictive of efficacy in neuropathic pain conditions, especially those with a central component. Therefore, Newron has decided to keep the long-term preclinical studies ongoing, which are required for a potential filing of the compound at a later point in time. Based on the feedback from potential licensees to the outcome of SERENA, Newron is currently evaluating their interest to share the potential of ralfinamide in pain and psychiatric diseases.