VANCOUVER, British Columbia—BetterLife Pharma Inc. has announced an agreement with the University of California San Diego (UCSD) School of Medicine for preclinical behavioral pharmacology studies of TD-0148A, a second-generation lysergic acid diethylamide (LSD) derivative. BetterLife believes the therapy will mimic the therapeutic potential of LSD without producing its psychoactive side effects.
“TD-0148A is a potential new therapy to treat debilitating psychiatric disorders with high unmet need such as severe treatment-resistant depression and post-traumatic stress disorder. BetterLife’s goal is to bring this treatment to the clinic as soon as possible, and the expertise of Dr. Halberstadt, a leading scientist in the field of psychedelic behavioral pharmacology, will help us realize our vision,” said Ahmad Doroudian, CEO of BetterLife Pharma.
As part of the research agreement, Dr. Adam L. Halberstadt and his team will work with BetterLife to test TD-0148A in various preclinical models established in their lab. The team’s expertise lies in understanding how psychedelics and related compounds interact with the serotonergic system, and how those molecules might be developed to treat psychiatric and neurodevelopmental disorders. Halberstadt’s research focuses on the pharmacology of psychedelic drugs and their derivatives. He is a co-founder of the Psychedelics and Health Research Initiative at UCSD, and served as the primary editor of the 2018 book Behavioral Neurobiology of Psychedelic Drugs.
“We are excited to have the opportunity to examine TD-0148A in our established preclinical models,” Halberstadt added. “Given the high rate of resistance to selective serotonin reuptake inhibitors and other first-line treatments for major depressive disorder, there is an urgent need for new anti-depressant medications. LSD and other psychedelic drugs have been shown to have anti-depressant effects, but some patients will not tolerate their hallucinogenic effects. Therefore, non-hallucinogenic derivatives of these drugs, such as TD-0148A, represent a promising alternative.”
BetterLife also reported earlier in March that the company’s wholly-owned subsidiary, Altum Pharmaceuticals, entered into a Letter of Intent with Pontificia Universidad Católica de Chile to conduct a randomized placebo-controlled trial (IN2COVID) testing Altum’s proprietary inhaled interferon alpha-2b product, AP-003. The company anticipates the trial will start in the second quarter of this year, and be completed by the end of the third quarter.
“We are excited to be collaborating with the School of Medicine at Pontificia Universidad Católica de Chile to conduct this trial in COVID-19 patients,” noted Doroudian in a press release. “The team, as well as the trial center, are the leaders in Chile in conducting COVID-19 trials.”
The goal of the IN2COVID trial is to confirm the benefit of inhaled IFN-a2b in early stage COVID-19 patients. The trial will have a randomized placebo Phase 1 portion in healthy subjects, followed by a randomized placebo-controlled Phase 2 portion in early stage COVID-19 patients (<5 days of diagnosis of COVID-19). The IFN-a2b treatment arms will receive nebulizer-administered AP-003 twice a day for 10 days.
The study will be conducted by a multidisciplinary team of investigators led by Dr. Arturo Borzutzky, director of the Translational Allergy and Immunology Laboratory, Department of Infectious Diseases and Pediatric Immunology at the School of Medicine at Pontificia Universidad Católica de Chile.
“We are pleased to be partnering with Altum to bring AP-003 to COVID-19 patients. There are several reasons why there is a need for an effective, easy to administer, non-invasive treatment such as AP-003 for COVID-19. These reasons include: the time it will take to vaccinate the whole population; not knowing the duration of protection afforded by the current vaccines; emergence of SARS-CoV-2 variants; and emergence of possible totally new coronavirus pandemics in the future,” Borzutzky pointed out. “AP-003, being a Type I interferon, is a broad acting anti-viral agent, and therefore potentially could be effective in all these scenarios.