Perception Neuroscience initiates Phase 2a study of PCN-101 (R-ketamine) for treatment resistant depression
September 14 2021 - 8:00AM
Perception Neuroscience (Perception), an atai Life Sciences (atai)
biopharmaceutical company focused on developing innovative
therapies in neuropsychiatric diseases, today announced the
initiation of a Phase 2a clinical study to evaluate the safety and
efficacy of PCN-101 (R-ketamine). R-ketamine is a stereoisomer of
ketamine being developed for therapeutic treatment of psychiatric
disorders such as Treatment Resistant Depression (TRD). The Phase
2a clinical trial has received the necessary regulatory and ethics
approvals to initiate the study.
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 Terence Kelly, PhD, CEO of Perception Neuroscience. “TRD
impacts nearly 100 million people around the world, making up a
third of patients living with depression; currently they are either
undertreated or unresponsive to existing treatment options. We
believe PCN-101 holds promise in helping such treatment-resistant
patients, as a potential rapidly-acting antidepressant which can be
administered at home.”
"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 atai Life
Sciences. "Initiating this Phase 2 clinical study is a major step
for our teams at Perception and atai and is a great achievement. We
believe this work has the potential to deliver a novel option with
diversified delivery capabilities that could decrease overall
healthcare utilization, which may help us move toward our greater
mission to improve care for patients who suffer from TRD.”
About PCN-101Perception 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, IncPerception
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 atai Life Sciences.
About atai Life Sciences 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 New York,
London, and Berlin. For more information, please visit
www.atai.life.
Forward-Looking StatementsThis 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 U.S. Securities and Exchange Commission (“SEC”) on June 21,
2021, as such factors may be updated from time to time in atai's
other filings with the SEC. Any forward-looking statements
contained in this press release speak only as of the date hereof
and accordingly undue reliance should not be placed on such
statements. atai disclaims any obligation or undertaking to update
or revise any forward-looking statements contained in this press
release, whether as a result of new information, future events or
otherwise, other than to the extent required by applicable law.
Investor Contact:Greg WeaverChief Financial
OfficerEmail: greg.weaver@atai.life
Media Contact:Anne DonohoeKCSA Strategic
CommunicationsPhone: +1 (212) 896-1265Email: atai@KCSA.com
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