Sevuparin

 

Update: 29 March 2019

The first of three cohorts has been successfully dosed in a phase I study to assess the safety of subcutaneous administration of Sevuparin for the treatment of SCD.

This double-blind, placebo-controlled Phase I study, complements the currently ongoing Phase II study which is examining the safety of intravenous Sevuparin infusion for the treatement of vaso-occlusive crisis (VOC). The Phase II study has completed enrollment and will report data in mid-2019.

The Phase I study will include approximately 24 Healthy Volunteers in three ascending single-dose cohorts in the USA, providing SCD patients a novel, non-opioid, therapy that can be dosed at home and could possibly pave the way for a therapy that could be used ‘on demand’ as a patient feels an oncoming painful VOC.

Sources:

http://www.modustx.com/first-cohort-dosed-in-us-phase-1-study-of-subcutaneously-administered-sevuparin/

 

Update: 01 February 2019

Sevuparin is a new compound based on the commonly used blood thinner, heparin. It is able to restore blood flow and prevent obstruction of small blood vessels due to its anti-adhesive and anti-inflammatory characteristics.

Received Orphan Drug Designation by FDA and EMA.

A multi-centre, phase II, randomized, double-blind, placebo-controlled study to explore efficacy and safety of sevuparin infusion (over 2 – 7 continuous days) for the management acute vaso-occlusive crisis (VOC) in adolescent and adult patients with SCD is currently ongoing.

  • Study locations include: Netherlands, Turkey, Lebanon, Bahrain, Oman, Saudi Arabia and Jamaica.
  • The study is expected to end in March 2019.

Sevuparin has received rare paediatric disease designation from the FDA (April 2018). This will provide the developing company a number of incentives and facilitations towards further study of the safety and efficacy of the drug and marketing authorisation and exclusivity.

In addition, phase 1 clinical study will be launched in the US to test the safety of subcutaneous administration of sevuparin for the treatment of SCD.  The FDA has accepted sevuparin’s investigational new drug application.

 

Sources:

https://clinicaltrials.gov/ct2/show/NCT02515838?term=sevuparin

http://www.modustx.com/research-development/clinical-trials/

http://www.modustx.com/sevuparin-receives-rare-pediatric-disease-designation-fda-treatment-children-sickle-cell-disease/

http://www.modustx.com/modus-therapeutics-announces-fda-acceptance-sevuparin-ind-treatment-sickle-cell-disease/