ERGO.L Regulatory News (ERGO)

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Ergomed notes co-development partner Asarina Pharma announcessuccessful topline data for its Phase IIa Clinical Study with Sepranolone inPremenstrual Dysphoric Disorder ('PMDD')

London, UK - 3 April 2017: Ergomed plc (LSE: ERGO) ('Ergomed' or 'the Company'), a company dedicated to the provision of specialised services to the pharmaceutical industry and the development of new drugs, notes co-development partner, Asarina Pharma, has today announced the publication of its phase IIa clinical study with Sepranolone in PMDD in Psychoneuroendocrinology. This study was completed prior to the companies entering into a co development relationship.

Sepranolone is Asarina's lead product candidate and potentially the first therapy to target the underlying cause of PMDD, a severe and disabling form of premenstrual syndrome affecting approximately 5% of menstruating women. Recruitment for a phase IIb clinical study is expected to begin towards the end of 2017.

Under the terms of the co-development partnership with Asarina Pharma, Ergomed will receive an equity stake in the company.

Dr. Miroslav Reljanovic, Chief Executive Officer of Ergomed, said:

"We are delighted by Asarina's successful phase IIa clinical study with Sepranolone for women suffering with PMDD. Sepranolone has the potential to become a first-in-class therapy, normalising the work and family life of women affected by this debilitating disorder. The results of this study encouraged us to enter into a co-development relationship with Asarina and we look forward to working together on the next stage of development."

The full text of the announcement from Asarina Pharma is as follows:

Asarina Pharma`s phase IIa clinical study with Sepranolone in premenstrual dysphoric disorder meets primary endpoint.

Copenhagen - March 31, 2017. Asarina Pharma, a drug development company focusing on the development of a novel therapy for severe premenstrual symptoms, publishes the efficacy and safety data from the randomized, controlled trial involving a total of 120 women with PMDD, in Psychoneuroendocrinology.

Premenstrual Dysphoric Disorder (PMDD) is a condition with severe impact on the daily life of approximately 5 per cent of all women during their fertile years. The condition is caused by an altered sensitivity in the brain to an endogenous steroid produced following ovulation, resulting in monthly recurrent episodes of depression, anxiety and mood lability. Current treatment options include anti-depressants and oral contraceptives, which have little effect and are not well tolerated by patients.

Asarina's lead product candidate, Sepranolone, is the first potential therapy to target the underlying cause of PMDD. Based on the efficacy data, that met the standard FDA primary endpoint for studies in PMDD and strong safety profile from the phase IIa study, Asarina is now preparing a Phase IIb clinical trial, to be conducted in the US, Germany, UK, Poland and Sweden with recruitment starting in the fall of 2017.

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About Ergomed

Ergomed plc is a profitable UK-based business providing drug development services to the pharmaceutical industry and has a growing portfolio of co-development partnerships. It operates in over 50 countries.

Ergomed provides clinical development, trial management and pharmacovigilance services to over 100 clients ranging from top 10 pharmaceutical companies to small and mid-sized drug development companies. Ergomed successfully manages clinical development from Phase I through to late phase programmes.

Ergomed has a wide therapeutic focus, with a particular expertise in oncology, neurology and immunology and the development of orphan drugs. Ergomed believes its approach to clinical trials is differentiated from that of other providers by its innovative Study Site Management model and the use of Study Physician Teams, resulting in a close relationship between Ergomed and the physicians involved in clinical trials.

As well as providing high quality clinical development services, Ergomed is building a portfolio of co-development partnerships with pharma and biotech companies which share the risks and rewards of drug development. Ergomed leverages its expertise and services in return for carried interest in the drugs under development. Lastly, Ergomed recently acquired a pipeline of proprietary development products for haemostasis in surgical settings. For further information, visit: http://ergomedplc.com.