Histalean?® is comprised of betahistine dihydrochloride, a centrally active dual action pro-histamine. Betahistine is an agonist of type 1histamine receptors and an inverse agonist (inhibitor) of type 3 histamine receptor (the negative autoregulatory receptor of histamine), acting in concert to activate the histamine system, which downregulates feeding and enhances alertness and cognition. Based on the highly safe generic drug, approved since the 1960s in >100 million patients suffering from M?©ni re ™s disease (vertigo) in most countries; it is unavailable in the US, where, although safety was not doubted, it was withdrawn by the FDA in 1972 for insufficient data of efficacy in Menieur ™s.
The Company has recently extended its clinical supply agreement with Grunenthal-Italy to include higher dose extended release formulations of betahistine and is planning to initiate follow-on escalating dose clinical trials this year. "The commercial opportunity of adjunctive Histalean?® therapy, to enable "safer" antipsychotic treatment is clear, considering the annual turnover of $15 billion in this market, says Dr. Ami Eyal, CEO of Bio-Light, the major investor in Obecure, adding that we are currently seeking financial and pharmaceutical partners to assist us to achieve this challenge.
SOURCE Bio-Light Israel Life Science Investments Ltd.