First sevuparin dose administered in Modus Therapeutics’ Phase 1b LPS provocation study
STOCKHOLM, SWEDEN – December 1, 2021: Modus Therapeutics Holding AB (“Modus”), a company developing innovative treatments for patients with major unmet medical needs, announces that the first clinical trial participant has been dosed with sevuparin in the company's clinical Phase 1b LPS provocation study.
The randomized, placebo-controlled Phase 1b study will evaluate the effects of sevuparin on the symptoms of healthy volunteer participants who have been injected with the bacterial toxin lipopolysaccharide (LPS) in the skin (local inflammation) and blood (systemic inflammation). Provocation with LPS is a well-established model used to characterize the early stages of septic inflammation by provoking measurable symptoms.
The study will also evaluate the safety profile of sevuparin when used in combination with standard prophylactic, blood-thinning heparin.
John Öhd, CEO of Modus Therapeutics, commented: “We are proud to announce this important milestone for Modus. The start of our first clinical study in the sepsis program means that the new strategy we set out in early spring has now been put into action. We have been able to keep to this ambitious schedule thanks to the efficiency of our knowledgeable team members and partners, which is even more impressive considering our successful listing was only 4 months ago. The results of this study are expected to be presented in 2Q2022 and will serve as the basis for the follow-up trial we plan to start in the second half of 2022, studying the use of sevuparin in patients with sepsis.”
The study is conducted in collaboration with the Center for Human Drug Research (CHDR) in Leiden, The Netherlands. CHDR is an independent Contract Research Organization (CRO) specializing in advanced early clinical drug research and has strong expertise in advanced inflammation models.
Sevuparin is a new polysaccharide that has the potential to break the molecular chain of events leading to vascular damage and plasma leakage in patients with sepsis or septic shock and other systemic inflammation conditions. Sevuparin does so by directly binding and neutralizing agents released from damaged white blood cells that are known to threaten the vascular integrity.
This information is such information that Modus Therapeutics Holding AB is obliged to publish in accordance with the EU Market Abuse Regulation. The information was submitted, through the care of the contact person below, for publication on December 1, 2021.
For more information on Modus Therapeutics, please contact:
John Öhd, CEO, Modus Therapeutics
Telephone: +46 (0) 70 766 80 97
E-mail: [email protected]
Certified Adviser
Svensk Kapitalmarknadsgranskning AB
Telephone: +46 11 32 30 732
E-mail: [email protected]
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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.