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Successful Phase 1a has Forendo eyeing Phase 1b
April 2019
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TURKU, Finland—Forendo Pharma announced in March that it had completed its Phase 1a study of FOR-6219, an HSD17B1 inhibitor for treating endometriosis. This first-in-human trial was a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, food effect and pharmacokinetics of single and multiple ascending oral doses of FOR-6219 in 36 healthy postmenopausal women. The compound can selectively inhibit local estrogen production in the endometrium and endometriotic lesions without impacting systemic estrogen levels. The tested doses were found to be safe and well tolerated, with only grade 1 adverse events reported, and no adverse events that led to study discontinuation. FOR-6219 demonstrated dose-proportionate exposure and no significant food effect, and Forendo intends to initiate a Phase 1b trial this summer to demonstrate proof of mechanism.

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