Merck to commence MK-6913 phase IIa efficacy trial for treatment of hot flashes/hot flushes

The Swedish biotech company Karo Bio (Reuters: KARO.ST) today announced that Merck & Co., Inc., through an affiliate, plans to enter a clinical phase IIa trial with the collaboration's lead investigational drug candidate, MK-6913, identified as part of their joint research collaboration. No milestone payment to Karo Bio is associated with the initiation of phase II clinical development.

The randomized, double-blind, placebo- and active-controlled study will assess the safety, tolerability, and efficacy of MK-6913 for the treatment of moderate-to-very-severe vasomotor symptoms (hot flashes/hot flushes) in postmenopausal women. It is estimated that 300 patients will be enrolled in the study.

''We strongly believe that novel compounds targeting the estrogen receptor continue to hold great potential in the field of women's health”, commented Per Olof Wallström, President & CEO of Karo Bio.

The collaboration with Merck targets estrogen receptors with the aim to develop novel treatments in the field of women’s health. The joint drug discovery phase of the collaboration with Merck was completed in 2002. MK-6913 is the first such estrogen receptor compound arising from the collaboration to enter Phase II.

Under the terms of the collaboration agreement, Merck has the exclusive worldwide rights to all compounds identified during the collaboration and is responsible for their further preclinical and clinical development. Karo Bio has the rights to certain milestone payments from Merck based upon the further successful clinical development of the compound and final drug approval. Karo Bio also has the rights to royalties on future drug sales. The announcement today does not trigger a milestone payment to Karo Bio.

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