ATAI Life Sciences NV ATAI is deploying a multipronged approach to accelerate the development of mental health treatments.
The company operates a decentralized hub and spoke model in which each of ATAI's platform companies focuses on one lead compound in a single lead indication.
"We believe our three pillars of people, processes and enabling technologies maximize the probability of clinical success at our platform companies," Glenn Short, vice president of early development at ATAI, said Tuesday at Benzinga's Psychedelics Capital Conference.
The Three Pillars: Starting with people, the company believes that expanding its reach across small teams with a degree of entrepreneurial autonomy is the best approach to help enable clinical success.
ATAI's process is centered around a focus on differentiated mental health treatments that present significant commercial potential, Short said.
The company currently has four enabling technologies, which have the potential to support ATAI's pipeline development and be used as patient support tools.
"Our operating model provides development teams with the support and incentives to rapidly advance their therapeutic candidates or technologies in the most cost-efficient manner," Short said. "We intend to continue to incubate, acquire and invest in companies that share our goal of advancing transformative mental health treatments."
The Pipeline: Short highlighted data from the Compass Pathways PLC CMPS clinical trial of COMP360 psilocybin therapy for treatment-resistant depression. The compound psychedelic effect lasts between four and six hours so a patient can anticipate staying in a clinic for an entire day following treatment, he said.
"This may present logistical problems, not only to the patient but also to some clinician offices as well, thus we're developing R-ketamine as a non-psychedelic rapidly acting antidepressant that has the potential to be used at home."
At lower sub-anesthetic doses, ketamine has a rapid onset antidepressive activity, known to improve an individual's mood within hours of administration, Short explained.
In order to capture the benefits of R-ketamine, ATAI is developing PCN-101 as a rapid-acting antidepressant with potential for at-home use. Early studies show a rapid reduction in depressive symptoms within an hour of administration that can last for up to seven days, Short said, adding that "These changes are not accompanied by disassociation, the psychedelic-like phenomenon that is present with ketamine."
ATAI has set up a randomized Phase 2 study of PCN-101 that is expected to establish human proof-of-concept.
Short also highlighted Viridia Life Sciences' VLS-01, a synthetic formulation of DMT for the treatment of depression. DMT is the active psychedelic component in Ayahuasca, a brew made from several plants used ritualistically in parts of Central and South America.
"We are developing DMT as a transmucosal buccal formulation with a release profile designed to create a psychedelic effect lasting between 30 and 45 minutes," Short said. "We believe that this short duration of psychedelic effect may reduce patient in-clinic time, as well as lessen the logistical burden on clinics, allowing for broader utilization of VLS-01 when compared to psilocybin."
Short also noted that ATAI subsidiary Revixia Life Sciences is focused on developing a proprietary form of Salvinorin A to treat a variety of mental health disorders. Salvinorin A is a naturally occurring psychedelic compound with pharmacology differentiated from that of psilocybin or DMT.
ATAI expects Phase 1 clinical trials of RLS-01 to initiate in the second half of 2022.
Lastly, EmpathBio's EMP-01 is an oral formulation of an MDMA derivative being developed for the treatment of post-traumatic stress disorder (PTSD).
"Given the comorbidities associated with those suffering from PTSD, EMP-01 might be a potentially safer alternative to MDMA and as such we are focusing on PTSD as the primary indication with the potential for treating generalized anxiety disorder as well," Short said.
Watch the full event below:
ATAI Price Action: ATAI has traded between $4.62 and $22.91 over a 52-week period.
According to data from Benzinga Pro, the stock was up 1.22% at $5.17 at time of publication.
Photo: courtesy of ATAI.
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