firstwordpharmaFebruary 24, 2019
Tag: Karolinska , portfolio , Modus Therapeutics
Karolinska Development's portfolio company Modus Therapeutics announces today that the first cohort has been successfully dosed in its phase 1 study to explore the pharmacokinetics, safety and tolerability of subcutaneous sevuparin injections in healthy adults.
Modus Therapeutic develops sevuparin for diseases with high unmet medical need with a focus on sickle cell disease (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.
Intravenously administered sevuparin is currently being tested in a phase 2 study which completed enrollment in January 2019 and will report data in mid-2019. In order to broaden sevuparins potential to help SCD patients outside of the hospital setting, Modus Therapeutics in parallel explores subcutaneously administered sevuparin. The first cohort in a phase 1 single ascending dose study exploring pharmacokinetics, safety and tolerability of subcutaneous sevuparin injections in healthy volunteers has now successfully been dosed in a U.S clinical trial facility. Subcutaneously administered sevuparin has the potential to become a home-based, self-administered therapeutic option for patients with SCD in the stages before and after a VOC - the very painful crisis that are believed to contribute to the patient's gradual accumulation of complications such as organ failure and stroke.
In November 2018 the FDA accepted Modus Therapeutics IND application. The phase 1 study with subcutaneously administered sevuparin is the first step in moving the clinical development of sevuparin to the United States.
"This is an important milestone for Modus Therapeutics as it both paves the way for a new treatment option for patients with sickle cell disease and constitutes the start of the clinical development of sevuparin in the US", says Viktor Drvota, CEO of Karolinska Development.
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