The article Atai Life Sciences Launches Phase 1 MDMA Trial was originally published on Microdose.

“We continue to execute on our pipeline – having achieved multiple Phase 1 milestones over the last months. These include the completion of the clinical phase of the PCN-101 drug-drug interaction (DDI) study, database lock of the GRX-917 Phase 1 SAD/MAD trial, completion of the SAD portion of the KUR-101 Phase 1 trial, and the initiation of the VLS-01 Phase 1 trial. Going forward, we are focusing on R&D programs that we anticipate generating meaningful clinical data readouts over the next two years,”

This was the statement by Srinivas Rao, Chief Scientific Officer & Co-Founder of atai, during the company’s most recent financial results.

With the strength of their cash reserves and breadth of their pipeline, Atai is considered by many to be the de facto industry leader. But despite having the highest number of programs running, none of them are very advanced in the clinical trial process (PCN-101 is the only trial out of Phase 1).

Which is why the news of a new trial entering Phase 1 is good news for Atai and its investors.

Atai’s wholly-owned subsidiary, EmpathBio, has received Medsafe central regulatory and The Health and Disability Ethics Committees (HDEC) ethics approvals to initiate a Phase 1 trial to assess the safety and tolerability of orally administered EMP-01 in 32 healthy volunteers.

EMP-01 (MDMA derivative) is being studied for the treatment of Post-Traumatic Stress Disorder (PTSD). A worthy line of study and one that could have an easier regulatory path forward once MAPS gets FDA approval for its MDMA for PTSD trial.

See the full press release below.

Interested in more on Atai? Check out Atai Reports Q2 2022 Financial Results & Business Update and Atai Life Sciences Secures $175 Million Loan

atai Life Sciences Announces Initiation of Phase 1 Trial for its MDMA Derivative, EMP-01

– atai’s wholly owned subsidiary, EmpathBio, has received Medsafe central regulatory and The Health and Disability Ethics Committees (HDEC) ethics approvals to initiate a Phase 1 trial to assess the safety and tolerability of orally administered EMP-01 in 32 healthy volunteers

– EMP-01 is a 3,4-methylenedioxy-methamphetamine (MDMA) derivative under development for the treatment of post-traumatic stress disorder (PTSD) and other indications

NEW YORK and BERLIN, Sept. 27, 2022 (GLOBE NEWSWIRE) — atai Life Sciences N.V. (Nasdaq: ATAI) (“atai”), which is developing EMP-01, a 3,4-methylenedioxy-methamphetamine (MDMA) derivative for the treatment of post-traumatic stress disorder (PTSD) and other indications, announced today its Phase 1 study has received regulatory and ethics approvals required from Medsafe and HDEC, respectively, to initiate participant enrollment.

The Phase 1 randomized, double-blind, placebo-controlled study is designed to evaluate the safety and tolerability of single-ascending doses of EMP-01 in healthy adult participants, as well as assess the usability and acceptability of the IDEA-1 app in delivering “set and setting” content to participants in preparation for their EMP-01 administration. This study also includes a range of behavioral assessments that, in conjunction with the PK and safety readouts, are expected to inform the design of and doses tested in future Phase 2 clinical trials of EMP-01.

In the U.S. alone, an estimated 9.3 million people meet the criteria for a PTSD diagnosis according to the National Institute of Health. At present, the only FDA-approved treatments for PTSD are two selective serotonin reuptake inhibitors (SSRIs), paroxetine and sertraline. Evidence shows that two-thirds of patients either do not respond or have only a partial response to these medications.

MDMA itself is an amphetamine derivative that possesses complex pharmacology and is believed to act by increasing the release of monoamines like serotonin, norepinephrine, and dopamine in the brain, as well as stimulating neurohormonal activity. Studies show that this activity may result in the anxiolytic, prosocial, and empathic responses commonly associated with the approximately six-hour experience. As a result, MDMA is often classified as an entactogen rather than a typical psychedelic.

EmpathBio is focused on developing MDMA derivatives with different pharmacological profiles than MDMA. These modifications are designed to separate the entactogenic effects of MDMA from some of the known side effects, specifically its stimulant-associated effects. This may result in an improved safety profile compared to MDMA in the treatment of PTSD populations with comorbidities including hypertension, history of stroke, and cardiovascular disease. If successful, such an approach could help minimize some of the transient physiological changes caused by MDMA and potentially expand the PTSD patient pool medically eligible for the therapy.

“The need for new interventions for PTSD is critical given the current lack of effective treatments for those suffering from this debilitating mental health disorder,” said Florian Brand, CEO of atai Life Sciences. “We are thrilled to have received the necessary approvals for the initiation of the Phase 1 trial for EMP-01 in order to further progress the potential development of this promising new therapy.”

“Data on MDMA-assisted psychotherapy strongly suggests its potential for the treatment of PTSD,” said Glenn Short, Senior Vice President, Early Development of atai Life Sciences. “However, we are focused on refining MDMA’s entactogenic pharmacology to provide a greater therapeutic index. This study is a critical step towards ensuring that entactogen-assisted therapy is available to everyone who is struggling with PTSD.”

atai anticipates topline results in H2 2023 for this Phase 1 study.

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.

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. For more information, please visit www.atai.life.

About EmpathBio

EmpathBio is a biotech company dedicated to developing 3,4-methylenedioxymethamphetamine derivatives in conjunction with digital therapeutics to deliver efficient, scalable treatments to patients on their own terms.

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