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Psychedelic nasal sprays that require shorter periods of clinical supervision have shown promise for treatment-resistant depression, and biotechnology hopes that this type of drug will become a viable option for use in mental health conditions.
Atai Life Sciences and Beckley Psytech announced on Tuesday that in a trial of mebfotenin benzoate, based on compounds found in many plants and the toad venom of Colorado River, patients showed a “clinically meaningful” reduction in depressive symptoms the day after treatment.
The effect of a single treatment continued in an 8-week trial without plateauing by the end, with no serious side effects.
Up to half of 300mn people diagnosed worldwide with depression suffer from treatment-resistant depression, defined as not responding to two or more different antidepressants.
Many biotech companies developing psychedelic treatments for mental illness are looking for ways to reduce the amount of clinical supervision they need, making them faster and cheaper for their healthcare systems and patients.
Cosmo Feilding-Mellen, CEO of Beckley Psytech, said if data from a large trial is positive and approved, it would be a “great step forward for patients.”
A trial of 193 patients from six countries found that the majority were ready for discharge 90 minutes after the dose. This is a significant improvement from previous trials of psychedelic treatments in which patients require oversight throughout the day.
Cosmo Feilding-Mellen, CEO of Beckley Psytech, said if data from a large trial is positive and approved, it would be “a great advancement for patients and a pioneering a new era of mental health.”
Atai Life Sciences and Beckley Psytech hope to incorporate the drug into the Phase 3 trials required for approval. Regulators have not yet approved psychedelic treatments, but many are currently testing for conditions such as post-traumatic stress disorder, anorexia and other types of depression.
Feilding-Mellen said the company “always believed that psychedelics could really make a huge difference for patients with mental states.”
“The big question was how did you make these treatments really accessible and commercially viable for patients and the healthcare system?” he said.
Johnson & Johnson uses a clinic network to provide Spravato nose spray for treatment-resistant depression that requires two hours of clinical supervision. This existing infrastructure could allow other companies to easily deploy psychiatric drugs that require supervision.
Some companies in this sector hope that new U.S. Health Secretary Robert F. Kennedy JR will be open to the therapeutic use of psychedelics.
Berlin-based Atai Life Sciences purchased UK biotech Beckley Psytech in an all-share deal valued at $390 million last month.
Stocks in psychedelic companies have fallen sharply since their 2021 peak. Many have not yet generated sales, and investors see them on the high-risk edge of the sector. ATAI Life Sciences stocks have fallen 89% since its first public offering in June 2021.
However, Feilding-Mellen said their interest in medicine was higher than three years ago. “There is no doubt that there is a growing acceptance and interest in psychedelics as a treatment from top-tier biotech funds and pharmaceutical companies,” he said.
