Modus Therapeutics completes recruitment for Phase 1b LPS provocation study
STOCKHOLM, SWEDEN – September 27, 2022: Modus Therapeutics Holding AB (“Modus”), a company developing innovative treatments for patients with major unmet medical needs, announces that recruitment has been completed into the company's clinical Phase 1b LPS provocation study evaluating the potential of its lead asset, sevuparin, for the treatment of sepsis and septic shock.
The randomized, placebo-controlled Phase 1b study evaluates the effects of sevuparin on the symptoms of healthy volunteer participants who have been injected with the bacterial toxin lipopolysaccharide (LPS). Provocation with LPS is a well-established model used to characterize the early stages of septic inflammation by provoking a range of measurable symptoms.
The study is also assessing the safety profile of sevuparin when used in combination with the standard prophylactic, blood-thinning heparin.
John Öhd, CEO of Modus Therapeutics, commented: “We are very pleased to have met this milestone in our Phase 1b clinical trial, which represents a significant step forward in our development program intended to establish sevuparin as a ground-breaking new sepsis treatment. It also highlights that our organization, in conjunction with its partners, has been successful in delivering this objective in line with our updated plan and against the very challenging circumstances due the lingering effects of the COVID-19 pandemic. We are now looking forward to Q4 when we plan to communicate the high-level data from the study once the appropriate analyses have been concluded.”
The Phase 1b study is being 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.
Data from the Phase 1b study will be used to inform the protocol of the planned Phase 2 study with sevuparin in patients with sepsis. This study is expected to start in 2023.
Sevuparin is a new polysaccharide drug 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 September 27 2022.
For more information on Modus Therapeutics, please contact:
John Öhd, CEO, Modus Therapeutics
Telephone: +46 (0) 70 766 80 97
E-mail: john.ohd@modustx.com
Certified Adviser
Svensk Kapitalmarknadsgranskning AB
Telephone: +46 11 32 30 732
E-mail: 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.