Clinical trial services and drug development company Ergomed has entered a co-development agreement with Asarina Pharma to conduct the Phase IIb clinical trial of Sepranolone (UC1010) to treat premenstrual dysphoric disorder (PMDD).
PMDD is characterised by cyclic symptoms such as depression, anxiety, irritability, mood lability and loss of emotional control consistently at the latter part of the menstrual cycle, affecting a woman's personal and professional life.
The disorder is experienced during the fertile period beginning from menstruation until menopause.
Under the agreement, Ergomed will conduct Asarina’s multicentre, multinational, randomised Phase IIb clinical trial next year and will jointly invest into the trial in return for an equity stake in Asarina.
Ergomed CEO Dr Miroslav Reljanovic said: “We are delighted to be the co-development partner for Asarina as it embarks upon its Phase IIb clinical trial programme for Sepranolone, which has the potential to be a first-in-class therapy for this serious disease.
“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 in providing clinical trial services to support such development.”
Asarina’s proprietary Sepranolone is an endogenous, small molecule acting as a GABA-A modulating steroid antagonist (GAMSA).
Sepranolone has demonstrated its safety, efficacy and pharmacokinetics profile in an exploratory, double-blind, randomised, placebo-controlled, clinical phase I/II study conducted by Asarina on 120 women with PMDD.