These Five Biotech Stocks Are Developing Potentially Groundbreaking Mental Health Treatments
Over the years, mental health has become a bigger and bigger issue, especially since the COVID-19 pandemic. In fact, the World Health Organization estimates that the pandemic triggered a 25% increase in the prevalence of anxiety and depression around the globe.
While the pandemic is over, it did bring increased awareness to the extreme impacts mental illness can have on those with such conditions and their loved ones. In fact, one group that has long struggled with mental illness, often in silence, is veterans.
Nov. 11 is Veterans Day, so it seems fitting to discuss biotech companies that are working on groundbreaking treatments for post-traumatic stress disorder (PTSD) and other mental health concerns. As of January 2023, there were over 160 medications in development for mental illness, a number that has likely increased since PhRMA compiled its last report on the subject.
Here are six biotech companies working on promising treatments that could bring much-needed relief to veterans and anyone else who struggles with mental illness.
ATAI Life Sciences
Atai Life Sciences (ATAI), which received backing from well-known venture capitalist Peter Thiel, is developing a platform designed to accelerate the development of psychedelic solutions to treat mental health. The company is working on several drug development programs across multiple mental health indications that have a large unmet need.
RL-007, which is designed to treat cognitive impairment associated with schizophrenia, is the candidate that's the furthest along in atai's pipeline. RL-007 looks poised to enter Phase 3 clinical trials. The company is also developing GRX-917, which is in Phase 2 trials to treat generalized anxiety disorder.
Atai's other candidates include VLS-001 for treatment-resistant depression, DMX-1002 for opioid-use disorder, and EMP-01 to treat PTSD. All of these candidates are toward the end of Phase 1 trials. The company also has equity interest in COMPASS Pathways, which is developing COMP360 for treatment-resistant depression, PTSD, and anorexia nervosa.
Mind Medicine
MindMed (MNMD) is also developing treatments for mental health using compounds with psychedelic activity with the aim of combining neuroscience with psychology. The company states that it's developing psychedelic-inspired medicines to treat the "underlying causes of distress in the brain" rather than merely treating the "distressing symptoms" of those conditions.
The lead candidate in MindMed's pipeline is MM-120, which the company says has displayed evidence of clinical benefit across multiple conditions. The company reports that over 10,000 patients have been treated with it in clinical trials so far and that it utilizes a novel mechanism of action to target the neurobiology of chronic pain.
MindMed is also working on MM-402 to treat autism spectrum disorder. The company's pilot clinical trial uncovered strong prosocial effects.
NRx Pharmaceuticals
NRx Pharmaceuticals (NRXP) is developing an NMDA platform with a focus on serious, life-threatening conditions with major unmet medical needs. The company's pipeline is powered by its proprietary, dual-targeted mechanism of action that modulates the NMDA and 5HT2A receptors and NRX-100, a proprietary version of IV ketamine for suicidal depression.
NRx's lead candidate is NRX-101, which was granted a breakthrough-therapy designation by the FDA based on the Phase 2 trial. Currently, NRX-101 is in a Phase 2b/3 clinical trial to treat severe bipolar depression in recently suicidal patients and suicidal treatment-resistant bipolar depression, with data expected in the coming months.
The primary component of NRX-101, D-cycloserine, is also in a Phase 2 trial funded by the U.S. Department of Defense to treat chronic pain. The results of this trial are expected by the end of 2023.
Additionally, NRX-100 is expected to be the subject of a new drug application (NDA) for suicidality in 2024.
Relmada Therapeutics
Relmada Therapeutics (RLMD) aims to improve the standard of care for central nervous system (CNS) disorders with a focus on mental health. The company is currently advancing its ongoing Phase 3 trial of REL-1017 to treat major depressive disorder (MDD). REL-1017 is the only candidate in Relmada's pipeline.
REL-1017 functions as an NMDA receptor (NMDAR) channel blocker that targets hyperactive GluN2D channels. Relmada explains that NMDARs have been found to play a primary role in physiological neural plasticity. In fact, NMDAR dysfunction has been implicated in many CNS disorders, including major depressive disorder.
Relmada reports that its Phase 2 trials of REL-1017 displayed "rapid, robust and sustained antidepressant effects" in patients with inadequate response to standard treatments. The drug candidate is now moving into Phase 3 trials to evaluate its effectiveness in a large number of patients with MDD.
SAGE Therapeutics/ Biogen
Small-cap SAGE Therapeutics (SAGE) has teamed up with the much-larger Biogen (BIIB) to develop zuranolone (branded as Zurzevae) for MDD and postpartum depression (PPD). SAGE focuses on modulating the GABA and NMDA receptors, which are both critical neurotransmitter systems that contribute to regulating CNS function.
As part of its pipeline, SAGE also developed brexanolone, which has been branded as Zulresso, to treat PPD. In March 2019, Zulresso became the first FDA-approved treatment for postpartum depression, while Zurzuvae became the first oral FDA-approved treatment for PPD in August 2023.
SAGE Therapeutics is also developing SAGE-718 to treat cognitive dysfunction in Huntington's disease and Parkinson's disease and mild cognitive impairment and mild dementia in Alzhaimer's disease. SAGE-324 is in development to treat essential tremor.
Investing in biotechs focused on mental health
The National Institutes of Health estimates that more than one-fifth of U.S. adults live with a mental illness, demonstrating the importance of uncovering life-changing treatments. Additionally, with such a wide range of different illnesses and symptoms, some mental illnesses can be especially challenging to treat, so it's good news that so many companies are working on promising treatments.
Ari Zoldan is CEO of Quantum Media Group, LLC. NRx Pharmaceuticals is a client of Quantum Media Group.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
Ari Zoldan
Ari Zoldan is the CEO of New York-based Quantum Media Group, LLC. The company provides investor relations, public relations and equity research services to publicly traded companies. As an on-air media personality, Ari can be seen regularly on major media outlets and is frequently quoted in mainstream news outlets covering business, innovation and emerging trends.
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