Karolinska Development AB announces that its portfolio company Dilaforette AB, a company focused on innovative treatments for patients with sickle-cell disease, and Arabian Gulf University (AGU) in Bahrain, have signed a Clinical Collaboration agreement for the Phase 2 proof of concept trial of sevuparin in patients with Sickle Cell Disease (SCD) experiencing acute Vaso-Occlusive Crisis (VOC)
Dilaforette and AGU’s collaboration will facilitate the development of Dilaforette’s lead candidate, sevuparin, for patients with SCD.
AGU will provide up to $1.2 million in non-dilutive funding for the study and assist with patient recruitment. This project will contribute to enhancing AGU’s capabilities in clinical research through training and engagement in phase 2 clinical trial. In return AGU will receive royalties on future product revenues which are capped at twice the financial support it provides to the Phase 2 proof of concept study.
The Phase 2 proof of concept sevuparin study is currently enrolling patients at several clinical sites in the Middle East, including Bahrain, where AGU is located.
Jim Van heusden, CEO of Karolinska Development, said: “This is an attractive deal for Dilaforette providing it with both non-dilutive finance and clinical trial support. We are looking forward to the results of this study given our belief that sevuparin could play an important role in treating the VOCs which cause significant morbidity and mortality in patients with Sickle Cell Disease.”
Sevuparin is a novel polysaccharide drug candidate developed to treat vaso-occlusive crises (VOC) in SCD by normalizing the reduced blood flow. Dilaforette has signed a co-development partnership with Ergomed to develop sevuparin, and in October 2015, they announced the start of recruitment into a multi-centre, international, randomised Phase 2 study performed in Europe and the Middle East. Results from this Phase 2 proof of concept trial with sevuparin are expected in the second half of 2016.