A precision mental health approach: Partnering with Massachusetts General Hospital and Harvard faculty to optimize and personalize drug development

At atai Life Sciences, we are committed to pioneering the development of highly effective mental health treatments that address the unmet needs of patients – but we can’t do it alone. Collaboration between industry and academia, especially at the early stages of development, can provide key insights to support the identification of biomarkers for clinical and regulatory success.

This post by our Senior Director in Clinical Science, Sarah McEwen, Ph.D., discusses how we are partnering with academia as part of our precision mental health innovation efforts, to accelerate and personalize the next generation of effective treatments into the hands of those in need. ?

Precision mental health is built on the core principles of ‘precision medicine’ – which aims to uncover why patients with the same clinical diagnosis and similar symptoms often exhibit different responses to the same treatment. Given the significant heterogeneity amongst patients with mood disorders, it makes sense that there is no ‘one size fits all’ when it comes to mental health treatment. Up to 70% of patients with depression don’t recover after their first prescribed drug. And furthermore, there are currently no reliable and validated biomarkers that lend to stratifying patients and predicting their response to treatments in both clinical trials and in clinical settings leading to low trial success rates and/or poor clinical outcomes.

That’s why a precision mental health approach to drug development in psychiatric disorders has become a foundational component of our work at atai.?Achieving this innovative approach requires collaboration with academic partners and practicing psychiatrists early in the clinical research stage of mental health drug development to better analyze and characterize the mechanisms of action of promising investigational compounds.

A key partnership we have forged in this area is with Massachusetts General Hospital (MGH), Harvard Medical School’s largest teaching hospital, with whom we initiated a clinical study in November 2022. ?MGH currently offers treatments with proven in-market neuroplasticity-inducing effects for patients with severe and refractory depression and has an exceptional team with deep expertise in this field, including our Principal Investigators on this study, Dr. Cristina Cusin , Associate Professor of Psychiatry at Harvard and Director and Founder of the MGH Ketamine Clinic and Dr. Susie Huang , Associate Professor of Radiology at Harvard and Radiologist and faculty at Athinoula A. Martinos Center for Biomedical Imaging?in the Division of Neuroradiology at MGH.

?Neuroplasticity, which involves changes in the function and structure of the brain, can transform a person's thought patterns, personality traits and behaviors. It is believed to be one of the core biological mechanisms underlying recovery in those with mental health conditions. However, there are no reliable non-invasive biomarkers measuring the extent of neuroplasticity in patients to date - which is a primary motivation for our collaborative study. Together, we will utilize non-invasive neuroimaging methods (EEG, fMRI and DWI) to identify biomarkers associated with neuroplasticity and treatment response in patients with treatment-resistant depression (TRD) undergoing known neuroplasticity-inducing treatments.

The study also includes a collection of resting-state fMRI scans, which measures spontaneous fluctuations in blood flow in the brain when not engaged in a task. For the analyses of these biomarkers, atai is collaborating with a pioneer in the field of functional neuroimaging and precision psychiatry applications Dr. Susan Whitfield-Gabrieli, Professor of Psychology at Northeastern University and Director of the Northeastern University MRI Center, and her graduate student and an atai fellowship recipient, Clare Shaffer.

Our objective is to leverage the findings from this study to use as early biomarkers predictive of treatment response. Ultimately, the goal is to generalize this biomarker approach to include other psychoplastogen compounds and design more efficient clinical trials with greater likelihood of success. In addition to supporting more targeted drug development processes, our hope is that the biomarkers derived from precision mental health research will, in future, be helpful in clinical practice in identifying the potentially most effective treatments for different patient subtypes, leading to better patient outcomes and more efficient utilization of health care resources.

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If you want to learn more:

• Learn more about our programs?here .
• Read our press release about our clinical study in collaboration with Massachusetts General Hospital here .

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Forward-Looking Statements:

Please note that the information provided above contains 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 important factors that could cause actual results to differ materially from those in the forward-looking statements, including the risks, uncertainties, and assumptions described under "Summary Risk Factors" below, “Risk Factors” in Item 1A of Part I, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Item 7 of Part II and elsewhere in our Form 10-K for the year ended December 31, 2022, filed with the Securities and Exchange Commission.

Any forward-looking statements made herein speak only as of the date of this communication, 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 hereof or to conform these statements to actual results or revised expectations.

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Background on atai Life Sciences AG:

atai Life Sciences (Nasdaq: ATAI), is a clinical-stage biopharmaceutical company aiming to accelerate the development of new medicines across its companies to achieve clinically meaningful and sustained behavioral change in mental health patients.?

We have a pipeline of five clinical-stage drug development programs, several of which are envisioned to be paired with a proprietary, internally developed digital therapeutics platform. Of these five clinical drug candidates, three are psychedelic and two are non-psychedelic in nature. In addition, we use AI-based computational and medicinal chemistry approaches as part of our drug discovery efforts to generate the next generation of psychedelic and related molecules. As of our latest publicly filed report, we also have a 22.4% stake in COMPASS Pathways (separately listed on Nasdaq; CMPS).