News Release Details

BERLIN, Aug. 12, 2021 (GLOBE NEWSWIRE) -- atai Life Sciences (Nasdaq: ATAI) ("atai"), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, announced the launch of Revixia Life Sciences (Revixia), a wholly owned subsidiary developing Salvinorin A (SalA) to treat a variety of mental health disorders.

Derived from Salvia divinorum, SalA is a unique non-nitrogenous agonist of the kappa-opioid receptor (KOR) with potential use in treatment-resistant depression (TRD), substance use disorder (SUD) and pain. Traditionally, Salvia divinorum has been used by the Mazatec people in Oaxaca, Mexico for a variety of illnesses, such as diarrhoea, headaches and rheumatism, as well as for palliative care.

SalA is an atypical KOR agonist with a complex pharmacological profile. Its mechanism of action (MoA) shows no interaction at the 5-HT2A serotonin receptor, which is the main molecular target for the classical hallucinogens such as psilocybin and DMT. Instead, it is hypothesised that SalA indirectly influences the cannabinoid system, as well as being an allosteric modulator of the µ opioid receptor.

Clinically, there are published reports of the potential benefits of Salvia divinorum in the treatment of TRD. Karl Hanes reported on 7 patients with TRD who described relief from depressive symptoms with continued oral consumption of salvia leaves three times a week. Most of these patients reported lasting benefits from their use of the herb with significantly reduced scores on quantitative measures of depression and several reported benefits such as mood enhancement, increased feelings of relaxation and increased self-awareness. Additionally, a recent study in rhesus monkeys demonstrated that SalA can decrease oxycodone self-administration in rhesus monkeys in a dose-dependent manner, suggesting that combinations of oxycodone and the KOR agonists should be further investigated as potential analgesics with reduced abuse liability.

"Due to SalA’s short psychedelic effect, it will be an attractive option for those who would like psychedelic treatment but are unwilling or unable to participate in longer sessions," said Glenn Short, CEO of Revixia. "The shorter experience will allow for more practical administration and monitoring, which may even make it possible to attend psychotherapy sessions on the same day."

"While SalA has until now been understudied, its unique MoA may allow for combination with SSRIs, potentially giving patients a better chance in beating depression," said Srinivas Rao, CSO and co-founder of atai Life Sciences. “We’re thrilled to be pursuing SalA and progressing research, as we strive for new treatments.”

Importantly, Revixia’s product will be paired with a digital therapeutic being developed by atai company Introspect Digital Therapeutics, with the aim of streamlining preparation, integration, and continued patient engagement.

“In exploring SalA, Revixia aims to develop a product with a differentiated pharmacological and treatment effect. Considering the significance of prior evidence in humans in parallel with the substantial unmet need in TRD, we believe Revixia has high commercial potential and an increased probability of success in the clinic,” said Florian Brand, CEO and co-founder of atai Life Sciences. “SalA is a great product candidate that magnificently matches the criteria we strive for, with recognized synergies across the atai platform.”

Development is underway with clinical trials expected to begin in the second half of 2022.

About atai Life Sciences
atai is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. atai was founded in 2018 as a response to the significant unmet need and lack of innovation in the mental health treatment landscape. atai is dedicated to acquiring, incubating and efficiently developing innovative therapeutics to treat depression, anxiety, addiction, and other mental health disorders. atai's business model combines funding, technology, scientific and regulatory expertise with a focus on psychedelic therapy and other drugs with differentiated safety profiles and therapeutic potential. By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines across its companies, seeking to effectively treat and ultimately heal mental health disorders. atai's mission is to bridge the gap between what the mental healthcare system currently provides and what patients need. atai is headquartered in Berlin, with offices in New York and London. For more information, please visit www.atai.life.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any express or implied statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements are neither promises nor guarantees, but involve known and unknown risks and uncertainties that could cause actual results to differ materially from those projected, including, without limitation, the important factors discussed under the caption “Risk Factors” in atai's prospectus pursuant to Rule 424(b) filed with the U.S. Securities and Exchange Commission (“SEC”) on June 21, 2021, as such factors may be updated from time to time in atai's other filings with the SEC. atai disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by applicable law.

Investor Contact:
Greg Weaver
atai – Chief Financial Officer
Email: greg.weaver@atai.life

Media Contact:
Anne Donohoe
KCSA Strategic Communications
Phone: +1 (212) 896-1265
Email: atai@KCSA.com