- BetterLife Pharma (BETR) has obtained positive results from an in vivo study of BETR-001 in beagles
- The study demonstrated a low probability of toxicity as a result of drug accumulation in the patient’s system
- The company is in the process of filing an IND application with the FDA and expects to begin human trials in the second half of 2022
- BetterLife Pharma is an emerging biotechnology company focused on developing and commercializing two compounds to treat neuro-psychiatric and neurological disorders
- Shares in BetterLife Pharma (BETR) are up 30.23 per cent, trading at $0.28 per share
BetterLife Pharma (BETR) has obtained positive results from an in vivo study of BETR-001 in beagles.
BETR-001 (2-bromo-LSD, formerly TD-0148A) is a non-hallucinogenic derivative of lysergic acid diethylamide (LSD).
The in vivo study included oral bioavailability and food-effect pharmacokinetic (PK) data to determine whether the presence of food would affect the bioavailability of orally administered BETR-001.
Previously published studies have not included any data on PK for BETR-001.
This study, conducted by contract research organization Nucro-Technics, demonstrated no significant difference in bioavailability for fed versus fasted dogs.
During the study, the maximum systemic concentration of BETR-001 after a single oral dose was reached at 0.5 hours, suggesting a quick uptake of the drug into the systemic circulation.
Furthermore, the PK elimination constant of 0.4 per hour for BETR-001 indicates a low probability of toxicity as a result of drug accumulation in the systemic circulation.
“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,” said BetterLife CEO Dr. Ahmad Doroudian. “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.”
“These data,” he added, “together with the ongoing 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.”
BetterLife Pharma is an emerging biotechnology company focused on developing and commercializing two compounds, BETR-001 and BETR-002, to treat neuropsychiatric and neurological disorders.
Shares in BetterLife Pharma (BETR) are up 30.23 per cent, trading at $0.28 per share as of 12:56 pm EST.