Perception Neuroscience, an Atai Life Sciences ATAI subsidiary, is starting a Phase 2a clinical trial on PCN-101, its lead drug candidate.
The study will evaluate the safety and efficacy of a proprietary formulation of arketamine that could have a similar therapeutic action to ketamine in the treatment of depression, with less dissociative effects.
The Phase 2a trial is a double blind, placebo-controlled study in patients with treatment-resistant depression. Three parallel arms will enroll 31 patients at multiple locations. Patients will receive either placebo, a 30 mg dose, or a 60 mg dose of arketamine intravenously.
“[Treatment-resistant depression] 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,” said Terence Kelly, CEO of Perception Neuroscience.
In 2019, Janssen Pharmaceuticals, a Johnson & Johnson JNJ subsidiary, released Spravato, an FDA-approved nasal spray containing esketamine (arketamine’s mirror compound) for the rapid treatment of depression symptoms.
Perception said that non-clinical depression model studies in rodents suggest that arketamine could have more durable and potent effects than esketamine and potentially a more favorable safety and tolerability profile.
"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," said Florian Brand, CEO and co-founder of Atai.
Photo by Chokniti Khongchum from Pexels.
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