eClinical Technology and Industy News

NeuroSense Receives Approval in Germany to Enroll Patients in its Phase 2b ALS Trial

  • PARADIGM protocol is  approved in four countries: Israel, Italy, Canada, and Germany
  • Topline results expected in H2 2023

Excerpt from the Press Release:

CAMBRIDGE, Mass., Feb. 8, 2023 /PRNewswire/ — NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) (“NeuroSense”), a company developing treatments for severe neurodegenerative diseases, today announced that Germany’s Federal Institute for Drugs and Medical Devices (BfArM) approved the Company’s Clinical Trial Application (CTA) to enroll patients in PARADIGM, its Phase 2b study of its lead combination drug candidate PrimeC in the treatment of amyotrophic lateral sclerosis (ALS).

PARADIGM is a Phase 2b randomized, multi-center, multinational, prospective, double-blind, placebo-controlled study, with an open-label extension, to evaluate the safety, tolerability, and efficacy of PrimeC. To date, over 50% of the planned 69 study participants have been enrolled.

“We expect to enroll the first study participant in Germany in the next few weeks, and we are very pleased to receive regulatory clearance to enroll and dose people living with ALS also in Germany for our PARADIGM study,” stated NeuroSense’s Chief Medical Officer, Dr. Ferenc Tracik. “We are currently on track to complete enrollment and report data in the second half of this year.”

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