Acasti Pharma ( NASDAQ: ACST ) said it began dosing in a phase 1 bridging study of oral betamethasone spray GTX-102 in healthy children.
GTX-102 is a proprietary, concentrated oral spray of betamethasone intended to improve the neurological symptoms of Ataxia Telangiectasia (A-T) in a pediatric population. GTX-102 can be sprayed over the tongue of patients, who have difficulties swallowing, the company said in a Sept. 13 press release.
The phase 1 pharmacokinetic (PK) study will evaluate the oral spray GTX-102, against an betamethasone intramuscular injection, and an oral solution of betamethasone in 48 healthy people.
A-T is a neurodegenerative disorder characterized by progressive impaired coordination of voluntary movements (ataxia), reddish lesions of the skin and mucous membranes due to widening of certain blood vessels (telangiectasia), and impaired immune system functioning.
"We look forward to the completion of this PK study later this year, and assuming positive results, we expect to move rapidly into Phase 3 in the second half of 2023. Currently there are no drugs approved for A-T," said Acasti CEO Jan D'Alvise.
In addition, Acasti said that Prashant Kohli was named chief commercial officer.
Kohli previously served as the company's VP of Commercial Operations and held the same title at Grace Therapeutics, prior to its acquisition by Acasti in August 2021.
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Acasti begins dosing of GTX-102 for neurodegenerative disorder; appoints chief commercial officer