BetterLife Pharma Inc (CSE:BETR, OTCQB:BETRF) announced that it has obtained positive results from an in vivo oral bioavailability and food-effect pharmacokinetic (PK) study on BETR-001 in beagle dogs.
BETR-001 is a non-hallucinogenic derivative of lysergic acid diethylamide (LSD), the company said.
“We are very pleased with the results of the first oral PK study for BETR-001 drug manufactured by BetterLife’s patented synthesis and formulation process. Although 2-bromo-LSD has been tested in rodents and human studies in the past, this is the first study to characterize its PK profile in vivo”, said Ahmad Doroudian, BetterLife CEO, in a statement.
He added: “These data, together with the ongoing investigational new drug (IND) enabling nonclinical toxicology studies, will support the filing of BETR-001’s IND application with the FDA and initiation of human clinical trials in H2 2022.”
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The Vancouver, British Columbia-based company said that previously published studies have not included any data on PK for BETR-001. It was also unknown if the presence of food would affect the bioavailability of orally administered BETR-001.
The current study conducted by the contract research organization, Nucro-Technics in Scarborough, Ontario, demonstrated no significant difference in bioavailability and total exposure of BETR-001 in the PK profile of fed versus fasted beagle dogs after a single dose of oral BETR-001 was administered.
The study also revealed that the oral bioavailability (%F), defined as the fraction of the oral administered drug that reaches the systemic circulation, was calculated to be 61% and 63% for fasted and fed states, respectively, which is not a significant difference, the company said.
The company said that the findings demonstrate that oral administration of a single dose of BETR-001 can reach the therapeutic range in systemic circulation. The study also indicated that the BETR-001 contains a low probability of toxicity as a result of drug accumulation in the systemic circulation.
BetterLife Pharma is an emerging biotechnology company primarily focused on developing and commercializing two compounds, BETR-001 and BETR-002, to treat neuro-psychiatric and neurological disorders.
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