The Phase 2a trial is a double blind, placebo-controlled study in patients with TRD. Each of the 3 parallel arms will enroll 31 patients at multiple locations. Patients will receive either placebo, a 30 mg dose, or a 60 mg dose of R-ketamine intravenously.
Patients will be assessed for depressive symptomology over the subsequent 14 days using the Montgomery-Asberg Depression Rate Scale, or MADRS. Topline data from the study is expected to be reported at the end of 2022.
“We’re excited to take the next key step with this clinical trial to show the potential of PCN-101 for people living with TRD,” said
"We believe insight into the molecular properties of the single isomer, R-ketamine, has the potential to offer a highly differentiated profile from current treatment options," added Florian Brand, CEO & Co-founder of
About PCN-101
Perception Neuroscience is developing PCN-101 (R-ketamine) for the treatment of Treatment Resistant Depression. PCN-101 is a single isomer of ketamine and belongs to a new generation of glutamate receptor modulators with the potential for rapid acting antidepressant (RAAD) activity and anti-suicidal effects. Pharmacologically, PCN-101 is a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist. Nonclinical depression model studies in rodents suggest that R-ketamine could possess more durable and potent effects than S-ketamine despite a lower affinity to the NDMA receptor and potentially a more favorable safety and tolerability profile.
About
Perception Neuroscience is a New York City-based biopharmaceutical company committed to developing therapies for neuropsychiatric diseases. Perception's mission is to provide substantially more effective treatment solutions to serious psychiatric disorders. The company is a majority-owned subsidiary of
About
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 has offices in
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, including without limitation statements regarding the initiation of the Phase 2a trial by Perception and future activities thereunder, the potential of PCN-101, and similar statements of a future or forward-looking nature. 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
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