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NeuroDerm Replace Two Phase 3 Clinical Trials with Small Pharmacokinetic Trials

 

Clinical courses

NeuroDerm Ltd. , a clinical stage pharmaceutical company developing drugs for central nervous system (CNS) disorders, announced that 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.

In the End-of-Phase 2 meeting, the Company presented clinical data obtained to date from its ND0612 trials and discussed details of its clinical development plan and requirements for an eventual application. The FDA provided recommendations related to Chemistry, Manufacturing, and Control (CMC) specifications, device development, clinical trials design as well as the implications of the current orphan drug status of Duopa® levodopa carbidopa intestinal gel (LCIG).

 

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.

Notwithstanding the Company’s changes to its U.S. regulatory development plans, the Company’s clinical, comparative bioavailability-based EU regulatory development strategy remains unchanged, pending an anticipated meeting with EU authorities in January.

“We are extremely pleased with the outcome of this FDA meeting that led us to replace two large, Phase 3 efficacy trials, with small PK trials,” said Oded Lieberman, PhD, CEO of NeuroDerm. “We are encouraged by the support that we have received from all those who care about Parkinson’s disease and share our hope that ND0612 will transform patients’ lives.  ND0612 has been designed to become the first non-surgical continuous levodopa therapy. We hope that it may offer Parkinson’s disease patients a new, effective and convenient alternative to the highly invasive treatment options available today, that are associated with potentially serious and sometimes life-threatening side effects.  We are committed to bringing this innovative therapy to market as quickly as possible, and believe that a PK-based regulatory development route in the United States charts a clear path to ND0612 NDA submission.”

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