The Androgen Restored Contraception (ARC) project is in phase III development and a phase IIb/III clinical study is ongoing in Europe. Based on scientific advices obtained from regulatory authorities (EMA and FDA), only a limited phase III program is required.
In January 2019 Pantarhei Bioscience (PRB) out-licensed the ARC pill for final product development, regulatory approval and commercialisation to the Hungarian pharma company Gedeon Richter for the territory Europe, Russia, Latin America and Australia. Pharmaceutical partnerships for the US and Asia are still possible.
Women with a menstrual cycle have 5-10 times higher levels of testosterone (T) than estradiol (E2), a female hormone. When such women use a combined oral contraceptive pill (COC), both T and E2 are suppressed. The loss of E2 is compensated by the estrogen component of the pill (ethinyl estradiol (EE)), but testosterone is not replaced. The most important clinical consequences of the loss of testosterone are diminished sexual function, especially desire/arousal and mood changes.
ARC is a novel concept of oral contraception developed and patent protected by PRB with the aim to preserve sexual function and prevent mood disturbances. This is achieved by adding oral dehydroepiandrosterone (DHEA) to the COC. DHEA is a natural human adrenal androgen, that is metabolised partially to testosterone after oral intake. By the addition of 50 mg DHEA to a COC, testosterone levels are maintained and/or restored. The longstanding safety track record of DHEA use in the human at the low dose level used implies expected safety when DHEA is added to the pill.
A phase II development program has been performed by PRB demonstrating the efficacy and safety of the ARC pill concept. Favourable clinical effects on sexual function, especially sexual desire and arousability, and on menstrual cycle related mood symptoms were shown.