Neuroderm Ltd (NASDAQ: NDRM) is on fire today. As the race for a treatment for Parkinson’s Disease pushes forward, this small-cap Israeli company has generated a lot of interest. NDRM was in 16 hedge funds’ portfolios at the end of September.
Following its End-of-Phase 2 meeting with the United States Food and Drug Administration (FDA) in late October, the Company intends to pursue a comparative bioavailability regulatory path for the Company’s lead product candidate ND0612 based on comparative pharmacokinetic (PK) data in place of data from Phase 3 clinical efficacy trials. The FDA also reaffirmed that long-term safety data from the Company’s ongoing BeyoND trial (trial 012) should be part of the eventual New Drug Application (NDA) submission. ND0612 is the Company’s continuous, subcutaneously delivered levodopa/carbidopa (LD/CD) proprietary liquid formulation for the treatment of Parkinson’s disease.
Following the discussions with the FDA the Company has decided to discontinue preparations to initiate its Phase 3 clinical efficacy trial of ND0612H (trial 010) and suspend iNDiGO, its other ongoing Phase 3 trial (trial 007) for ND0612L. Both studies are no longer required for marketing approval and will be replaced by comparative PK studies that will be initiated in the upcoming months. The Company is also evaluating amending the iNDiGO trial to a life cycle management trial. In addition, the Company will add approximately 50 patients to its ongoing long-term BeyoND safety trial (trial 012) with a different dosing regimen in line with the planned PK studies, which may add approximately three months to the timeline for completing the study and eventual application.