Modus Therapeutics Announces New Strategy for the Clinical Development of Sevuparin as a Potential Treatment for Sepsis/Septic shock

No pharmaceutical products are currently approved for this major global healthcare and economic challenge

STOCKHOLM, March 10, 2021 /PRNewswire/ -- Modus Therapeutics AB, a company developing innovative treatments for patients with high unmet medical needs, announces an updated strategy that sees the Company focus on the clinical development of sevuparin as a new, important potential treatment for sepsis/septic shock, and possibly other severe inflammatory complications that millions of patients suffer from as a result of serious medical conditions in addition to sepsis such as major trauma and surgery, autoimmunity, and viral infection. Modus Therapeutics expects to start the first clinical trial in this new indication with sevuparin, which has already demonstrated a favorable safety profile, around the end of 2021.

In many patients, these severe conditions, result in severe uncontrolled systemic inflammation (also known as systemic inflammatory response syndrome, SIRS), which can then progress into shock and multi-organ failure.

The most severe type of sepsis, septic shock, is a leading cause of death in intensive care units worldwide, with mortality rates typically exceeding 30%. There is currently no pharmaceutical product available that is specifically meant to treat patients with sepsis. As a result, it is one of the costliest conditions to treat in the hospital care setting. In 2019, US in-patient care costs for patients with sepsis were estimated to amount to $23 billion.

John Öhd, CEO, Modus Therapeutics, commenting on today's announcement said,"I am excited about our new strategy for sevuparin, which aims to demonstrate that this clinical stage drug candidate, with a favorable safety profile, could become an important and much needed treatment for sepsis/septic shock. These insights were generated from our collaboration with Professor Lennart Lindbom and his Microvascular Physiology group at Karolinska Institutet. This work uncovered the significant benefits of sevuparin's multimodal action on the components driving systemic inflammation and allowed us to identify this exciting and promising new therapeutic opportunity. We plan to start the first clinical trial with sevuparin in this new program around the end of 2021 and I look forward to keeping you updated as we work to demonstrate that this project has the potential to transform the treatment landscape for patients with sepsis/septic shock."

Sevuparin is a clinical stage, innovative proprietary polysaccharide drug with a multimodal mechanism of action, including anti-inflammatory, anti-adhesive and anti-aggregate effects. It acts by interfering with the harmful agents^[1] generated by white blood cells during systemic inflammation. This interference can break the molecular chain of events that lead to vascular damage and plasma leakage in patients with sepsis/septic shock and other systemic inflammatory manifestations. This activity has been shown in pre-clinical animal models as well as in vitro using human cells, where sevuparin has been effective in protecting the blood vessels and vital organs.

There is significant clinical experience with sevuparin in humans, which has been administered to 145 healthy volunteers and patients with malaria and sickle cell disease including Phase 2. This safety data in patients will help accelerate development of sevuparin in new indications.

Modus Therapeutics has also today launched a new website which provides more background on the Company's revised strategy for sevuparin and its potential to transform the treatment options for sepsis/septic shock.

About Modus Therapeutics AB

Modus Therapeutics is a Swedish biotech company developing sevuparin with a focus on diseases with high unmet medical need. The Company's near-term focus is to develop sevuparin for patients with sepsis/septic shock, a severe and often fatal condition. Modus is backed by Karolinska Development AB (Nasdaq Stockholm: KDEV), KDev Investments AB, (Karolinska Development AB and Rosetta Capital), The Foundation for Baltic and European Studies (Östersjöstiftelsen) and Praktikerinvest AB.

About sevuparin

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 severe systemic inflammation

Severe systemic inflammation conditions (also known as systemic inflammatory response syndrome, SIRS) are feared complications of severe medical conditions such as infection, trauma, and major surgery. It is characterized by an uncontrolled systemic inflammatory response that can progress into shock and multi-organ failure. One such manifestation is septic shock, which is a leading cause of death in intensive care units worldwide, with mortality rates typically exceeding 30%.

In systemic inflammation reactions, vascular hyper-permeability caused by the inflammatory response, may cause significant endothelial damage, plasma leakage and excessive edema formation. The pulmonary circulation is particularly vulnerable leading to respiratory distress, and in time more advanced multi-organ damage ensues. Neutrophil granulocytes, releasing an array of potent inflammatory mediators exhibiting permeability–increasing properties, are critically involved in the capillary-alveolar barrier breakdown.

There is currently no pharmaceutical product available that can be specifically used to treat patients with uncontrolled systemic inflammation such as sepsis. The current standard of care for hospitalized patients relies on aggressive fluid therapy, vasopressors, oxygen, corticoid steroids and mechanical ventilation.

For further information, please contact:
John Öhd, CEO, Modus Therapeutics:
Tel: +46 70 766 8097
E-mail: john.ohd@modustx.com

Nathaniel Dahan or David Dible, Citigate Dewe Rogerson
Tel: +44 20 7638 9571
E-mail: modustx@citigatedewerogerson.com

Web modustx.com

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[1] Rasmuson et al, 2019