Acasti announces preliminary topline results met all outcome measures in the pharmacokinetic bridging study for gtx-102, the company's drug candidate for the treatment of ataxia telangiectasia

Laval, quÉbec, dec. 28, 2022 (globe newswire) -- acasti pharma inc. (“acasti” or the “company”) (nasdaq: acst and tsx-v: acst), a late-stage, specialty pharma company advancing three clinical stage drug candidates addressing rare and orphan diseases, announces that the preliminary topline results of the pharmacokinetic (pk) bridging study for gtx-102 met all outcome measures. the objectives of the study were to evaluate the bioavailability, pharmacokinetics, and safety of gtx-102, a novel, concentrated oral-mucosal metered spray of betamethasone in healthy volunteers. this new formulation is intended to improve the neurological symptoms of ataxia telangiectasia (a-t) in a pediatric population for which there are currently no fda-approved therapies. gtx-102 can be sprayed conveniently over the tongue of a-t patients, who often have difficulties swallowing. this pk study was the next step in the proposed 505(b)(2) regulatory pathway for gtx-102.
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