BetterLife Pharma Inc., a Canadian biotech company developing therapies for mental health disorders, announced positive results May 14 from a key safety study of its experimental drug BETR-001, a non-hallucinogenic derivative of LSD.
The company said an animal study assessing the cardiac and respiratory safety of BETR-001 found no significant issues at doses over 100 times higher than the anticipated starting dose for upcoming human clinical trials.
The preclinical study, known as a GLP cardiopulmonary safety evaluation, monitors effects on blood pressure, heart activity, breathing, body temperature and movement in animals implanted with biosensors after receiving the test drug.
BETR-001 did not adversely impact electrocardiogram readings, respiration, core body temperature or activity levels, BetterLife said.
“These findings further support the claim that BETR-001 demonstrates a much better cardiac safety profile compared to LSD, psilocybin and other serotonergic psychedelics,” said BetterLife CEO Ahmad Doroudian.
Unlike traditional psychedelics which interact with the 5-HT2B serotonin receptor linked to heart risks, previous studies showed BETR-001 avoids that receptor, reducing toxicity concerns.
BetterLife is developing BETR-001 as a potential treatment for depression, anxiety and neuropathic pain without the hallucinations associated with LSD and psilocybin. The company aims to file for investigational new drug approval with the FDA by the end of 2024, Doroudian said.