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Forendo Pharma, a clinical-stage drug development company focusing on novel treatments in women's health, today announced the completion of Phase 1 studies in healthy volunteers for its lead development program in endometriosis, FOR-6219, and provided a development outlook. The successfully concluded Phase 1 program demonstrated that FOR-6219, a HSD17B1 enzyme-targeting small-molecule, was safe and well-tolerated and delivered additional results supporting Forendo's therapeutic concept. The company is now planning the Phase 2 program including endometriosis patients in the US.
"The now completed Phase 1 program delivered an initial body of tolerability, safety and pharmacokinetic data. For chronic endometriosis treatment, tolerability and a lack of systemic estrogen deficiency-related side effects are of the utmost importance as we see current therapies struggling to be widely adopted due to their side effect profiles. A local effect on the target tissue with our intracrinology mechanism provides an opportunity for superior management of endometriosis," commented Risto Lammintausta, CEO of Forendo. "We are now looking forward to expanding our clinical development program into the US and potentially into complementary women's health indications, in addition to endometriosis. The upcoming Phase 2 program will transition the clinical evaluation of FOR-6219 into symptomatic patients and deepen our understanding of the drug's impact on the disease biology and endometriotic tissue."