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news.Bennu Pharmaceuticals, a clinical development subsidiary of Raptor Pharmaceuticals, has started the first clinical-stage program after dosing the first cohort in a Phase IIa study of oral 4-methylpyrazole in subjects with ALDH2 deficiency, or ethanol intolerance, as the initial development stage of its Convivia program.
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Bennu’s Phase IIa clinical study is being conducted in Hawaii. The study is examining an oral administration of the current liquid injectable dose form of 4-methylpyrazole (4-MP) that is marketed in the US for other indications. Up to 32 subjects of Japanese descent who have a history of flushing reactions from alcohol will participate in a randomized, double-blind, placebo-controlled, dose escalation study of this orally administered liquid 4-MP or placebo, concomitant with ethanol.
Participants will give subjective responses on severity of their symptomatic reactions and investigators will measure their blood levels of acetaldehyde and ethanol as well as heart rate and skin temperature, in order to evaluate tolerability, safety and efficacy of 4-MP at various dose levels. The results of the study are expected in June 2008.
Convivia is Bennu’s proprietary, oral formulation of 4-MP designed to reduce peak systemic acetaldehyde levels in ALDH2 deficient persons following alcohol consumption.