Ergomed plc, a UK-based company, providing drug development services to the pharma industry , and Dilaforette AB (Dilaforette) have entered into a co-development agreement for the phase II clinical development of sevuparin in patients with Sickle-Cell Disease (SCD) experiencing acute Vaso-Occlusive Crisis (VOC). Dilaforette is part of the Karolinska Development AB portfolio.
Under the terms of the agreement, Ergomed has been appointed as the clinical development organisation to conduct Dilaforette’s multicentre, multinational, randomized phase II study in SCD patients suffering from VOC. The study is planned to start in Q2 2015. Ergomed will furthermore co-invest a proportion of its revenues from the clinical and regulatory activities of the trial in return for an equity stake in Dilaforette.
VOCs are caused by sickled blood cells blocking the blood vessels, thereby reducing blood flow to organs leading to ischemia and often severe pain. Today, pain relief through opioids is the only available treatment for the patients during these episodes and there is therefore a profound unmet medical need for disease modifying treatments within VOC management. The blockage of blood flow caused by the sickled cells can also cause severe damage to various organs, such as the lungs, heart, spleen, kidneys and liver.
Commenting on the announcement, Dr Miroslav Reljanovic, CEO of Ergomed plc said: “We are very excited to co-invest in Dilaforette for the development of sevuparin, which has shown promising results in vivo on sickled red blood cells from SCD patients. As our first co-development agreement in orphan drug development and the fifth co-development agreement in our portfolio, this partnership reaffirms Ergomed’s commitment to developing orphan drugs, as well as to our innovative co-development model which we believe has the potential to generate significant value for our shareholders.”
Christina Herder, CEO of Dilaforette added: “SCD is a devastating disease affecting patients worldwide, for which there is today no specific effective treatment. We look forward to working with Ergomed, to take sevuparin into the next stage of development and trust this partnership to be an excellent opportunity to combine our expertise.”
In the light of the announcement, Dr Terje Kalland, Acting CEO of Karolinska Development comments: “With this agreement, Dilaforette is progressing swiftly towards the initiation of the company’s planned phase II trial in SCD. Based on the promising preclinical data, Dilaforette may hold the key to a major shift in the treatment of VOCs where treatment options today are very limited for this orphan disease. We welcome Ergomed as co-investors in Dilaforette, that is an important strategic company in our portfolio. This announcement confirms our strategy to syndicate investments together with specialized life science investors. We now look forward to the continued development of sevuparin.”
Sickle-Cell Disease (SCD) is a disabling and potentially fatal disease with a large unmet medical need in both the developed and developing world. SCD patients undergo on average one Vaso-Occlusive Crisis (VOC) per year. This acute complication is caused by sickle blood cells obstructing the blood flow to organs leading to ischemia and often severe pain. Long-term, SCD patients are at risk of organ damage and premature death.
Sevuparin is an innovative, disease-modifying proprietary polysaccharide drug, which has the potential to restore blood flow and prevent further microvascular obstructions in SCD patients. (via a multimodal, anti-adhesive mechanism). The microvascular obstructions cause the severe pain during VOCs and the high morbidity through organ damage as well the risk of premature death.
Dilaforette is a Swedish drug development company developing sevuparin, an innovative, proprietary polysaccharide drug, which has potential to restore blood flow and prevent further microvascular obstruction in both sickle cell disease and malaria patients.
Karolinska Development aims to create value for patients, researchers, investors and society by developing innovations from world class science into differentiated products that can be partnered.