Recipharm, a contract development and manufacturing organization based in Stockholm, Sweden, partnered with NeuroSense Therapeutics to develop PrimeC, a fixed-dose combination tablet for amyotrophic lateral sclerosis (ALS), the companies said.
PrimeC reportedly combines two FDA-approved drugs aimed at slowing disease progression by addressing multiple pathological processes, including microRNA dysregulation, iron accumulation and neuroinflammation.
Recipharm scientists overcame challenges in combining active ingredients with different physicochemical and pharmacokinetic properties by creating a controlled-release tablet designed to synchronize drug release and achieve the desired therapeutic profile, according to the company. The solution reportedly incorporates stability measures, taste-masking and scalability for late-stage clinical trials and future commercial supply.
NeuroSense CEO Alon Ben-Noon in a statement said Recipharm’s formulation expertise has been “instrumental in advancing PrimeC toward late-stage clinical development.” The company plans to begin a pivotal Phase 3 trial in 2025 and is preparing commercial manufacturing to support Canadian market entry under Health Canada’s NOC/c pathway.
PrimeC has Orphan Drug Designation from both the FDA and European Medicines Agency. Recipharm will manufacture registration and commercial batches to support regulatory submissions and market readiness, the companies said.
In March, Recipharm reported record-breaking revenue for 2024, driven largely by its biologics business. The company secured more than 140 contracts for new biological modalities, including RNA, plasmid DNA, live viruses, viral vectors, and live-microbial biopharma products. Its biologics arm, ReciBioPharm, was awarded a three-year Gates Foundation grant to support global RNA manufacturing technologies in low- and middle-income countries.
Recipharm also expanded its portfolio in 2024 through a partnership with Hongene Biotech to add sgRNA manufacturing, and launched a new Pilot Scale Development Center in Germany to strengthen oral solid dosage form development. The company has increased capacity in pre-filled syringes and lyophilization across Europe and the U.S., citing demand from top-tier pharmaceutical partners.