A clinical trial services and drug development UK-based Ergomed and its co-development partner Sweden-based Modus Therapeutics Holding AB have announced that, following a planned safety review by an independent Data Safety Monitoring Board, adolescents between the ages of 12 and 18 can now be enrolled in its ongoing Phase II clinical study with sevuprin in Sickle Cell Disease.
In addition, the study sample size will be expanded to 150 patients in total with top line results now expected in H1 2018 rather than in H1 2017. This amendment will allow to fully explore the clinical potential of sevuparin to support a pivotal Phase III study.
Dr. Miroslav Reljanovic, Chief Executive Officer of Ergomed, said:
“The decision to expand our joint Phase II clinical study with Modus Therapeutics will strengthen the study and resulting data. Broadening the inclusion criteria from adults to include adolescents with Sickle Cell Disease will allow us to fully explore the clinical potential of sevuparin to support a pivotal Phase III study in this indication. We look forward to reporting the data in the first half of 2018.”
Commenting on today’s announcement, Christina Herder, CEO of Modus Therapeutics, said: “This positive recommendation by the DSMB is an important milestone for our clinical Phase II study as it will allow us to include adolescents with SCD. As with adults, they are also in need of new treatments which are effective in resolving the severe and devastating VOCs, which cause them extreme pain and increase their risk of long-term complications including organ damage and premature death.”