Modus Therapeutics Holding AB, a company developing treatments for patients with high unmet medical needs, said that Symbiosis Pharmaceutical Services, a specialist contract manufacturing organization (CMO), has started manufacturing sevuparin drug product securing the supply for the Phase II clinical development in sepsis/septic shock and other conditions driven by systemic inflammation. This follows a recent drug supply agreement between Modus and Symbiosis covering the drug product needs for the Phase II program, beyond the Phase Ib LPS challenge study planned to start in Q4-21/Q1-22.
 
“Modus firmly believes there is an urgency to bring new improved medicines to this underserved field,” said John Öhd, CEO, Modus Therapeutics. “Timely delivery of drug product is of utmost importance for us to be able to meet the aggressive timelines of our planned development. The manufacturing of this new batch of sevuparin is an important step in securing supply to our Phase II program in patients with sepsis, planned to start in Q3/Q4 2022. We believe Symbiosis Pharma’s strong track record makes them our ideal partner and we look forward to a productive and rewarding collaboration.”
 
Sevuparin is a novel polysaccharide with the potential to break the molecular chain of events that lead to vascular damage and plasma leakage in patients with sepsis/septic shock and other conditions where systemic inflammation is involved. Sevuparin achieves this by directly binding and neutralizing agents released from activated white blood cells that are known to threaten vascular integrity.
 
Colin MacKay, founder and CEO of Symbiosis, said, “Our team is very proud to support Modus Therapeutics and its effort to develop a powerful treatment for sepsis/septic shock. With many years of direct experience manufacturing an array of medicines and vaccines for clinical trials and commercial markets, we are pleased to be able to support the accelerated clinical development of sevuparin and to add value and contribute to the successful achievements of Modus Therapeutics’ drug development milestones.”
 
Symbiosis, headquartered in Stirling, Scotland, is a CMO that specializes in the GMP manufacture and sterile fill/finish of vials for clinical trials and low-volume commercial supply. Offering fast access to manufacturing slots and accelerated release of drug product, Symbiosis is primed to meet demand for small-scale, fast-turnaround drug product manufacturing, while maintaining regulatory GMP compliance to the highest standards.