Modus Therapeutics Holding AB , a company developing innovative treatments for patients with high unmet medical needs, announces that Symbiosis Pharmaceutical Services Ltd (“Symbiosis”), 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.
John Öhd, CEO of Modus Therapeutics, commenting on the collaboration said: “Modus firmly believes there is an urgency to bring new improved medicines to this underserved field. 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 commented: “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 specialises 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.
About Modus Therapeutics and sevuparin
Modus Therapeutics is a Swedish biotechnology company headquartered in Stockholm that develops sevuparin with a focus on diseases with a high unmet medical need. The company’s focus in the near future is to develop sevuparin for patients with sepsis / septic shock, which is a serious and often fatal condition. Modus Therapeutics is listed on the Nasdaq First North Growth market (“MODTX”). More information is available at www.modustx.com
Sevuparin is a clinical stage, innovative proprietary polysaccharide drug with a multimodal mechanism of action, including anti-inflammatory, anti-adhesive, and anti-aggregate effects. Sevuparin is a heparinoid with markedly attenuated anti-coagulation features that allows severalfold higher doses to be given, compared to regular heparinoids, without the associated risk for bleeding side-effects. Two routes of administration of sevuparin are currently being tested – an IV formulation for in-patient administration and a subcutaneous formulation that allows ambulatory and home care administration.
About Symbiosis Pharmaceutical Services
Symbiosis Pharmaceutical Services Ltd (Symbiosis) is a CMO established in 2011 in response to an increasing global demand for niche, sterile manufacturing specialists that could satisfy product supply needs for clinical trials. The company created its purpose-built facility in Stirling, Scotland, specifically designed with ATMP, vaccine and biologic and small molecule production capabilities in mind to support biotech and pharmaceutical companies worldwide that require small-scale injectable products manufactured in short timeframes.
Manufacturing is performed in an FDA-inspected and MHRA-licensed facility, which enables the team at Symbiosis to fill products that require aseptic liquid filling and lyophilization. Regulatory compliance, technical capability and operational flexibility are core to Symbiosis’ offerings along with leveraging highly experienced people who deliver client drug development projects on time.
