BetterLife's Non-Hallucinogenic LSD's Clinical Studies, Braxia's Psychedelic Treatments Continue

Psychedelics biotech BetterLife Pharma BETRF announced its non-hallucinogenic LSD derivative, BETR-001, is progressing through IND-enabling studies  toward expected clinical studies targeting Major Depressive Disorder (MDD.) 

The 2-bromo-LSD molecule’s preclinical pharmacological profile is already complete, showing robust activity in several depression/anxiety animal models without producing hallucinogenic activity, and it is now undergoing animal toxicology studies. 

These studies include a toxicology study of a 28-day repeat dose in dogs, which has been completed and histopathological analyses are ongoing. 

Meanwhile, the GMP manufacturing of BETR-001 compound substance is also in its final stages.

CEO Dr. Ahmad Doroudian says the company is excited to be “about mid-way” through the IND-enabling toxicology studies, whose design is based on the guidance received from a pre-IND meeting with the FDA, and further stated BetterLife will apply to begin clinical studies “as soon as the IND-enabling studies are completed.”

Braxia Scientific: YoY Growth In Treatment Volumes And Upcoming Restructuring Plan

Psychedelics-assisted therapy provider Braxia Scientific Corp. BRAXF has reported treatment volumes across its clinical network increased by 26.2%, going from 2,785 in FY2022 to 3,516 patients in FY2023. 

The company’s five clinics are seeing increased demand. Specifically, the new Ottawa clinic provided 87% more treatments this fiscal year as compared to the prior year, following its completed building expansion in late 2022. The Kitchener-Waterloo location has treated 214 patients in its first operational months, starting in mid-2022.

Additionally, over the last four months (ending May,) Braxia saw its current clinic volumes continue to trend up, with 307 total average monthly treatments compared to 293 for FY2023, despite “very little marketing.” 

In the near term, the company is set to ramp up direct marketing efforts and improve its clinics’ efficiency with additional capacity (planned for September,) as well as to perform a restructuring plan to prioritize the growth of its brick-and-mortar clinics while reducing and rightsizing its cost structure, including the slowdown of its U.S.-based telemedicine business KetaMD.

On the latter, Braxia is reviewing the DEA’s recently announced proposed policy limiting patient supply of certain controlled medications, including ketamine, to 30 days without an in-person or in-clinic assessment. 

The rule changes could require KetaMD to either own or have an association with physical clinics to build out its business and, while the agency recently extended the health emergency flexibilities on allowed remote prescribing until Nov. 11. It is still unclear what happens after this temporary rule expires. 

The Braxia management is also seeking to review its longer-term U.S. strategy and planned rollout. At the moment, they decided to slow down KetaMD’s ramp-up, while searching for strategic partners and additional capital to roll out and offer the technology platform to U.S.-based ketamine clinics that do not hold HIPPA-compliant virtual capabilities.

Photo: Benzinga edit with photo by Bacsica, aiyoshi597, Gisele Yashar and metamorworks on Shutterstock.