Clinical trial services provider and drug development firm Ergomed Plc (LON:ERGO) has been contracted to conduct the phase IIb clinical study of Asarina Pharma’s Sepranolone drug.
Sepranolone is the first treatment designed specifically for women suffering from premenstrual dysphoric disorder (PMDD) – the most severe form of premenstrual syndrome.
Under the terms of the co-development agreement, Ergomed will run the multinational, randomised trial – due to start in 2017 – and will also co-invest into the study in return for an equity stake in Asarina.
"We are delighted to be the co-development partner for Asarina as it embarks upon its phase IIb clinical trial programme for Sepranolone,” said Ergomed chief executive Miroslov Reljanovic.
“This further expands the number of pipeline opportunities where we share in the potential upside as a drug is successfully developed through leveraging our expertise and experience.”
The PMDD treatment has the potential to be the “first-in-class” therapy for the disease, Reljanovic added.
Peter Nordkild, chief executive of Asarina said: “We believe Ergomed is an excellent partner to help us advance this innovative therapy through the clinic.”
Sepranolone has already proved its safety and efficacy in its clinical phase I/II study, with the treatment also showing “a statistically significant improvement” in PMDD symptoms compared to the placebo.
Around 5% of women experience some form of premenstrual syndrome during their fertile years, with depression, anxiety and irritability among the primary symptoms.