Modus Therapeutics Receives Regulatory Approval to Start a Phase 1b Clinical LPS Challenge Study with Sevuparin in the Netherlands
STOCKHOLM, SWEDEN – 9 November 2021: Modus Therapeutics Holding AB (“Modus”), a company developing innovative treatments for patients with high unmet medical needs, announces that it has received the approval for its planned phase 1b clinical trial with sevuparin by the competent authorities in the Netherlands.
The planned randomized, placebo-controlled Phase 1b study will evaluate the effects of intravenous sevuparin on the dermal and systemic lipopolysaccharide (LPS) induced inflammatory responses in healthy volunteers. The LPS challenge is a well-established model used to characterize the early stages of a septic reaction.
The study will also assess the safety profile of sevuparin in combination with regular prophylactic anticoagulant heparin use.
These evaluations will pave the way for a subsequent study evaluating sevuparin in patients with sepsis, which is planned to start during H2 2022.
The planned Phase 1b study will be performed in collaboration with Centre for Human Drug Research, CHDR in Leiden, The Netherlands. CHDR is an independent contract research organization (CRO) that specializes in cutting-edge early-stage clinical drug research. CHDR has a specialized interest and significant expertise in advanced inflammation models that make it particularly well-suited for this early clinical development work with sevuparin.
John Öhd, CEO of Modus Therapeutics, commenting on today’s approval said:
“The approval is a major milestone for Modus as it provides the first regulatory buy-in to the concept of treating septic inflammation with sevuparin. It also enables us to begin the clinical development of sevuparin in accordance with our planned timelines. We are very pleased to be collaborating with CHDR on this Phase 1b study, as it is recognized as a world leading early phase CRO with significant expertise in advanced inflammation models, including LPS challenge methodology. We look forward to providing updates on the results from this study in H1/Q2 2022.“
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 damaged white blood cells that are known to threaten vascular integrity.
Matthijs Moerland, Research Director at the Centre for Human Drug Research, commenting on today’s approval said:
“We’re delighted to embark on this interesting and important project with Modus. We think CHDR’s inflammation methodology matches sevuparin’s mechanism-of-action very well and look forward to characterizing the immunomodulatory effects of Modus’ compound in our unique LPS challenge model while at the same time furthering our experiences and expertise in this vital area of human physiology.”
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 November 9, 2021.
For more information on Modus Therapeutics, please contact:
John Öhd, VD, Modus Therapeutics
Telefon: +46 (0) 70 766 80 97
E-post: john.ohd@modustx.com
Certified Adviser
Svensk Kapitalmarknadsgranskning AB
Telefon: +46 11 32 30 732
E-post: ca@skmg.se
***
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.