First Cohort Dosed in U.S. Phase 1 Study of Subcutaneously Administered Sevuparin
STOCKHOLM, SWEDEN – 22 February 2019: Modus Therapeutics AB, a company developing innovative treatments for patients with high unmet medical needs and a focus on sickle cell disease (SCD), announces that the first cohort has been successfully dosed in its Phase 1, Single Ascending Dose Study to Explore the Pharmacokinetics and Safety & Tolerability of Subcutaneous Sevuparin Injections in Healthy Volunteers (HV). This study complements a large Phase 2 study which completed enrollment in January 2019 and will report data in mid-2019.
“This Phase 1 study launches an important pillar of our strategy to treat vaso-occlusion and thereby reduce pain by providing SCD patients with a novel, non-opioid, therapy that can be dosed at home,” commented John Öhd MD, PhD, CMO of Modus Therapeutics. “While our recent Phase 2 study focused on treating patients with vaso-occlusive crisis (VOC) by intravenous (IV) sevuparin infusion, the Phase 1 study with subcutaneously-administered (SQ) sevuparin will pave the way for a therapy that could be used ‘on demand’ as a patient feels an oncoming painful VOC.”
The VOCs, or “painful crises”, are a hallmark of SCD and are believed to contribute to the patient’s gradual accumulation of complications such as organ failure and stroke. Research suggests that reduction of the number of VOCs should improve patient outcomes and could increase the lifespan of these patients.
“We see an incredible opportunity for subcutaneous sevuparin as the only therapy in development with the potential to be used at home for the treatment of vaso-occlusion, expanding treatment options for SCD patients to the early hours of a VOC” Dr. Öhd continues.
Sevuparin is an innovative, proprietary polysaccharide drug with anti-adhesive, anti-aggregate and anti-inflammatory effects due to its multimodal mechanism of action. A large Phase 2 study of IV administered sevuparin completed enrollment in January 2019 with data readout expected mid-2019. This study is evaluating the potential for sevuparin to restore blood flow and prevent further microvascular obstructions in adolescents and adults with acute VOCs resulting from their SCD. The double-blind, placebo-controlled Phase 1 study will include approximately 24 HVs in three ascending single-dose cohorts in a U.S. clinical trial facility.
“It is important to recognize the strong role that patient research had in informing this important element of Modus’ sevuparin development program. Through this research we have observed that patients are often aware that they are about to develop painful crisis, are keen to have access to an at-home therapy that they can take in the first days of pain to prevent a hospital visit”, said Ellen K. Donnelly, PhD, CEO of Modus Therapeutics. “This study is also an important milestone for Modus as sevuparin’s clinical development is now taking place in the United States (U.S.) under the IND that was approved by the FDA in November 2018,” added Dr. Donnelly.
SCD is an inherited blood disorder which is characterized by severely painful VOCs that lead to organ damage due to a lack of oxygen delivery to the organs. Progressive organ damage limits the life expectancy of patients with SCD and lifetime medical care costs can exceed $1 million per patient with an estimated $1 billion spent annually on the disease in the U.S. In the U.S alone SCD is believed to affect approximately 100,000 individuals.
For further information, please contact:
Ellen K Donnelly, CEO, Modus Therapeutics:
Tel: +46 70 246 7554
David Dible/ Pip Batty, Citigate Dewe Rogerson
Tel: +44 20 7638 9571
FOR THE EDITORS
About Modus Therapeutics AB
Modus Therapeutics is a Swedish biotech company developing sevuparin for diseases with high unmet medical need with a focus on sickle cell disease (SCD). Sevuparin is currently being tested in a Phase II clinical study for SCD – a painful, inherited blood disorder affecting millions of people around the globe. Sevuparin has the potential to improve the SCD patients’ blood flow reducing their pain and the amount of time they will need to spend in hospital.
The investors in Modus are KDev Investments AB, (part of Karolinska Development AB (Nasdaq Stockholm: KDEV) and Rosetta Capital), HealthCap, The Foundation for Baltic and European Studies (Östersjöstiftelsen) and Praktikerinvest AB. For more information, please visit www.modustx.com
Sevuparin is an innovative, proprietary polysaccharide drug with anti-adhesive, anti-aggregate and anti-inflammatory effects due to its multimodal mechanism of action. Sevuparin has the potential to restore blood flow and prevent further microvascular obstructions in a number of diseases including SCD. In SCD, the anti-adhesive effects of sevuparin could thereby offer treatment of the underlying cause of vaso-occlusive crisis (VOC) in SCD patients, with earlier pain relief, fewer and shorter hospitalizations, reduced need of opioids and improved quality of life. Modus is currently enrolling patients in a Phase II study with the aim to complete enrollment in the study in late 2018.
About sickle cell disease
Sickle cell disease (SCD) is a painful, inherited blood disorder affecting millions of people around the globe and the most common inherited blood disorder in the U.S. affecting between 90,000-100,000 subjects, with medical care costs amounting to more than $1 billion. In Europe it is estimated that there are 35,000-40,000 SCD patients, with an even higher number in the Middle East and North Africa regions, with over 850,000 SCD patients. SCD patients’ blood cells form a sickled shape, which makes blood flow to vital organs difficult during acute intermittent episodes called vaso-occlusive crises (VOC), leading to severe pain and even premature death.
There is currently no pharmaceutical product available that targets the vaso-occlusive activity during a VOC in SCD patients. At present, the standard of care relies on strong intravenous pain medications and SCD patients often must be hospitalized to be treated