Recipharm Partners with NeuroSense to Advance ALS Therapy PrimeC into Phase 3

  • Recipharm has partnered with NeuroSense Therapeutics to develop PrimeC, a fixed-dose combination therapy targeting Amyotrophic Lateral Sclerosis (ALS).
  • The collaboration will support Phase 3 trials in 2025 and commercial supply, including manufacturing for early access in Canada.

Recipharm, a global CDMO, has collaborated with NeuroSense Therapeutics to develop PrimeC, a proprietary fixed-dose combination tablet for ALS. The therapy combines two FDA-approved drugs in a novel formulation designed to address multiple disease mechanisms such as microRNA dysregulation, iron accumulation, and neuroinflammation.

The partnership focused on overcoming formulation challenges caused by combining active ingredients with differing properties. Recipharm’s scientists created a controlled-release tablet synchronising both drugs’ release while ensuring stability, scalability and patient acceptability. “We are proud to contribute to the development of a therapy with the potential to make a meaningful difference for people living with ALS,” said Greg Behar, CEO of Recipharm.

NeuroSense is advancing PrimeC into a pivotal Phase 3 trial in 2025, building on promising results from preclinical and Phase 2b studies. The company is also planning early access in Canada through Health Canada’s NOC/c pathway, with Recipharm to support manufacturing registration and commercial batches in the second half of 2025.

PrimeC has an Orphan Drug Designation from both the US FDA and EMA. ALS remains a rare and progressive neurodegenerative condition with limited treatment options, typically leading to death within three to five years of diagnosis.

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