NEWPORT BEACH, CA – GABA Therapeutics, Inc has successfully completed the single ascending dose (SAD) stage of its Phase 1 study of GRX-917 in Melbourne, Australia.

Interim data from the SAD stage showed that GRX-917 was well tolerated and favorable safety results were observed up to 500mg. Furthermore, the results suggest that food substantially increased exposure, which could potentially improve efficacy.

The multiple ascending dose (MAD) study was initiated on September 22nd – and Phase 1 is expected to complete by end of Q1, 2022.
GABA Therapeutics plans to initiate phase 2a proof-of-concept (POC) efficacy studies by end of Q2 2022. Indications currently being evaluated include:
·        Social Anxiety Disorder
·        Depression, and
·        Essential Tremor.

Anxiety and depression are often comorbid. If GRX-917 is successfully developed and approved for both anxiety and depression, it would be attractive to physicians and psychiatrists seeking to address this co-morbidity – particularly if GRX-917 is confirmed to have rapid onset, minimal side effects and be non-addictive.

The combined global market for treatments of anxiety disorder and depression is forecast to exceed USD$19 billion by 2028.
See also atai Life Sciences public filings with the Securities and Exchange Commission, including its earnings release for the quarter ended June 30, 2021, which are available on its investor relations website at ir.atai.life.

For questions contact:
Richard G. Farrell
Chief Financial Officer

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NEWPORT BEACH, Calif., April 07, 2022 (GLOBE NEWSWIRE) — GABA Therapeutics, Inc, (“GABA”) a clinical-stage biotechnology company developing novel therapies for anxiety, depression and other neurological disorders, and part of the atai Life Sciences (“atai”) platform, announces the appointment of Mario David Saltarelli M.D., Ph.D. as Chief Executive Officer (CEO) and Chief Medical Officer (CMO) effective April 4, 2022. He joins GABA with more than 25 years of experience in the biopharmaceutical industry, primarily in senior executive roles at several market-leading companies including Pfizer, Abbott (AbbVie), Annexon, and Syntimmune. He succeeds former CEO and co-founder, Dr. Ian J. Massey.

“Mario has extensive experience in anxiety, depression and other CNS disorders, and has led companies through all aspects of clinical development, regulatory approvals, strategic planning and major capital raises and mergers / acquisitions,” said Dr. Massey. “Mario is the ideal leader to support GABA in advancing its lead compound, GRX-917, into phase 2 efficacy studies in anxiety, depression and other neurological indications, and in progressing GABA’s earlier stage, novel small molecule Rapid Acting Antidepressant (RAAD) program.”

About GABA Therapeutics

GABA Therapeutics, an atai Life Sciences platform company, is a clinical stage biotechnology company focused on addressing the growing, unmet medical need in serious psychiatric and neurological disorders, including depression, anxiety, epilepsy, and essential tremor.

GABA’s flagship product, GRX-917, is an improved, patent protected, deuterated version of an approved European anxiety medication (etifoxine) with comparable speed of onset and anxiolytic efficacy as the top two selling benzodiazepines, lorazepam and alprazolam, but without the side effects of sedation, amnesia, ataxia, and dependence associated with benzodiazepines. GRX-917, which has composition of matter patent protection through 2036, has an identical mechanism of action, biology and pharmacology as etifoxine, but with improved pharmacokinetics, resulting in superior bioavailability and lower dosage requirements. The company is on-track to complete the Phase 1 single and multiple ascending dose study of GRX-917 in the Q2/3 2022 and the initiation of a Phase 2a proof-of-concept trial is anticipated to follow in the second half of this year.

About atai Life Sciences

atai Life Sciences is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. 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 innovative compounds, including 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 to achieve clinically meaningful and sustained behavioral change in mental health patients.

atai’s vision is to heal mental health disorders so that everyone, everywhere can live a more fulfilled life. atai has offices in New York, San Diego, Boston, London and Berlin. For more information, please visit www.atai.life.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. GABA Therapeutics, Inc. (“GABA”), an atai Life Sciences N.V. (“atai”) platform company and atai, intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “anticipate,” “initiate,” “could,” “would,” “project,” “plan,” “potentially,” “preliminary,” “likely,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these words. All references in these Forward-Looking Statements to “we,” and “our,” refer to GABA and atai, as applicable. In addition, all statements contained in this news release other than statements of historical fact, including statements regarding the success, cost and timing of development of GRX-917, including the progress of related preclinical studies and clinical trials and related milestones, are forward-looking statements. The forward-looking statements in this news release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond our control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements.

We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives, and financial needs. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including without limitation: statements regarding the success, cost and timing of development of our product candidates, including the progress of preclinical studies and clinical trials and related milestones. Other risk factors include the important factors described in the section titled “Risk Factors” in atai’s most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”), as updated by atai’s subsequent filings with the SEC, that may cause our actual results, performance or achievements to differ materially and adversely from those expressed or implied by the forward-looking statements.

Any forward-looking statements made herein speak only as of the date of this news release, and you should not rely on forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, performance, or achievements reflected in the forward-looking statements will be achieved or will occur. Except as required by applicable law, we undertake no obligation to update any of these forward-looking statements for any reason after the date of this news release or to conform these statements to actual results or revised expectations.

Contact Information
Richard G. Farrell – Chief Financial Officer
rfarrell@gabarx.com

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GABA Therapeutics has continued to progress the development of GRX-917 without any material impact from the COVID-19 pandemic.

GABA Therapeutics recently completed its Phase 1 clinical trial of the anxiolytic etifoxine in Melbourne, Australia, on time and slightly ahead of budget. The two-stage, double-blind, placebo-controlled single and multiple dose study evaluated the pharmacokinetics, pharmacodynamics, and safety of oral etifoxine in 30 normal healthy volunteers.

“We are pleased that the Phase 1 study has provided important PK/PD data for etifoxine that will help enable  the preclinical and Phase 1 studies of GRX-917, the deuterated analog of etifoxine.” said Dr. Ian Massey, co-founder and CEO of GABA Therapeutics.

GABA Therapeutics is about to commence an FIM-enabling toxicology program for GRX-917. Manufacture of GRX-917 is proceeding well, and clinical grade material is expected to be available in September. The Phase 1 study of GRX-917 is planned to start dosing in Australia in Q1/2 2021 – COVID-19 permitting.

Etifoxine Background

Clinical studies have shown that etifoxine has comparable speed of onset and anxiolytic efficacy as the world’s top two selling benzodiazepines (Xanax® and Ativan®), without the side effects of sedation, amnesia, ataxia, and dependence associated with benzodiazepines. The drug is non-addictive, and adverse drug effects occurred in just 21 per million patients (0.0021%), based on a pharmacovigilance study released by the French National Agency for the Safety of Medicines and Health Products that found no cases of abuse, misuse, or dependence after analyzing over 14 million prescriptions of etifoxine between 2000 and 2012.

In animals etifoxine acts by increasing endogenous neurosteroids such as allopregnanolone, which are essential for maintaining healthy brain biochemistry. Neurosteroids can induce potent anxiolytic, antidepressant, anticonvulsant, and analgesic effects, mainly through interaction with the GABA channel, the main inhibitory system in the brain.

GABA’s flagship product, GRX-917, the deuterated version of etifoxine, has an identical mechanism of action, biology and pharmacology, as etifoxine, but with improved pharmacokinetics. Based on all the data for etifoxine, GRX-917 will be safer and clinically superior to America’s top two drug classes of anxiolytics: SSRIs/SNRIs and benzodiazepines. Additionally, the drug is not expected to be a controlled substance, since etifoxine is not a controlled substance in France or any other country in which it is sold. Currently, there is no clinically competitive anxiolytic drug on the market.

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Today, GABA Therapeutics commenced dosing for its Phase I clinical trial of the anxiolytic etifoxine in Melbourne, Australia – right on schedule. The Phase I, two-stage, double-blind, placebo-controlled single and multiple dose study will evaluate the pharmacokinetics, pharmacodynamics, and safety of oral etifoxine in up to 34 normal healthy volunteers.

“Data from this study could provide important insights for a broad range of neurological disorders beyond anxiety and depression.” said Dr. Ian Massey, co-founder and CEO of GABA Therapeutics.

Etifoxine Background

Clinical studies have shown that etifoxine has comparable speed of onset and anxiolytic efficacy as the world’s top two selling benzodiazepines (Xanax® and Ativan®), without the side effects of sedation, amnesia, ataxia, and dependence associated with benzodiazepines. The drug is non-addictive, and adverse drug effects occurred in just 21 per million patients (0.0021%), based on a pharmacovigilance study released by the French National Agency for the Safety of Medicines and Health Products that found no cases of abuse, misuse, or dependence after analyzing over 14 million prescriptions of etifoxine between 2000 and 2012.

Etifoxine appears to have a dual mechanism of action, leading to increases in endogenous neurosteroids such as allopregnanolone, which are essential for maintaining healthy brain biochemistry. Neurosteroids can induce potent anxiolytic, antidepressant, anticonvulsant, and analgesic effects, mainly through interaction with the GABA channel, the main inhibitory system in the brain. Although there is a great deal of clinical experience with etifoxine, little has been published on its pharmacokinetics and effects on neurosteroids in humans. Therefore, GABA’s Australian trial will be a key step in building reliable clinical data on Etifoxine’s efficacy and safety.

GABA’s flagship product, GRX-917, the deuterated version of etifoxine, has an identical mechanism of action, biology and pharmacology, as etifoxine, but with improved pharmacokinetics. Based on all the data for etifoxine , GRX-917 will be safer and clinically superior to America’s top two drug classes of anxiolytics: SSRIs/SNRIs and benzodiazepines. Additionally, the drug is not expected to be a controlled substance, since etifoxine is not a controlled substance in France or any other country in which it is sold. Currently, there is no clinically competitive anxiolytic drug on the market or in late stage development.

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We are pleased to provide some positive updates.

Inaugural Board Meeting

The company held its first Board of Directors meeting in San Francisco in early November.

Attendees included (left to right):

• Srini Rao M.D., Ph.D, Chief Medical Officer, GABA Therapeutics
• Ian Massey, D.Phil, CEO and Director, GABA Therapeutics
• Richard Farrell, CFO and Director, GABA Therapeutics
• Florian Brand, CEO, ATAI Life Sciences, and Director, GABA Therapeutics
• Olivier Dasse Ph.D, VP Chemistry, GABA Therapeutics
• David Putman Ph.D, Chief Scientific Officer, GABA Therapeutics
• Christian Fibiger Ph.D, Director, Independent
• Curtis Scribner M.D, Regulatory Affairs, GABA Therapeutics
• Greg Bates, Lead, Regulatory Affairs, ATAI Life Sciences

Absent was Matthias Luz, Chief Medical Officer, ATAI, who was appointed Chairman of the Board.

Approval to Conduct a Phase I – Etifoxine

GABA Therapeutics recently received approval to conduct a phase I clinical trial of the anxiolytic etifoxine in Melbourne, Australia. The Alfred Ethics Committee approved a phase I, two-stage, double-blind, placebo-controlled single and multiple dose study to evaluate the pharmacokinetics, pharmacodynamics, and safety of oral etifoxine in normal healthy volunteers. Dosing for the study will begin in January 2020 and will be conducted at Nucleus Network in Melbourne, Victoria.

We selected Australia to conduct our clinical trials to expedite the program (Australia allows dosing in humans pre-IND), and to benefit from the 43.5% tax rebate on eligible clinical costs. Furthermore, the exchange rate is currently 0.69.

“Etifoxine is a drug with which we have decades of clinical experience indicating effectiveness and safety,” said Dr. Ian Massey, co-founder and CEO of GABA Therapeutics. “We’re thrilled that we’ve received the green light and look forward to getting started.”

Etifoxine Background

Clinical studies have shown that etifoxine has comparable speed of onset and anxiolytic efficacy as the world’s top two selling benzodiazepines (Xanax® and Ativan®). In contrast to benzodiazepines, however, etifoxine produces its anxiolytic effects without the side effects of sedation, amnesia, ataxia, and dependence associated with benzodiazepines. In terms of safety, the French National Agency for the Safety of Medicines and Health Products released a pharmacovigilance study that found no cases of abuse, misuse, or dependence after analyzing over 14 million prescriptions of etifoxine between 2000 and 2012. Moreover, adverse drug effects occurred in just 21 per million patients (0.0021%).

Etifoxine appears to have a dual mechanism of action. It acts as a weak allosteric modulator at the GABA_a channel acting at a site unique from the benzodiazepine binding site. Perhaps even more importantly, it also acts at the mitochondrial translocator protein TSPO, leading to increases in endogenous neurosteroids such as allopregnanolone, which are essential for maintaining healthy brain biochemistry. Neurosteroids can induce potent anxiolytic, antidepressant, anticonvulsant, and analgesic effects, mainly through interaction with the GABA channel, the main inhibitory system in the brain. Although there is a great deal of clinical experience with etifoxine, little has been published on its pharmacokinetics and effects on neurosteroids in humans. Therefore, GABA’s Australian trial will be a key step in building reliable clinical data on Etifoxine’s efficacy and safety.

GABA’s flagship product, GRX-917, the deuterated version of etifoxine, has identical mechanism of action, biology and pharmacology, as etifoxine, but with improved pharmacokinetics. Based on all the data for etifoxine , GRX-917 will be safer and clinically superior to America’s top two drug classes of anxiolytics: SSRIs/SNRIs and benzodiazepines. Additionally, the drug is not expected to be a controlled substance, since etifoxine is not a controlled substance in France or any other country in which it is sold. Currently, there is no clinically competitive anxiolytic drug on the market or in late stage development.

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