PCN-101 R-ketamine Programme receives FDA Investigational New Drug clearance

pharmafile | January 13, 2022 | News story | Business Services  

The FDA has given Investigational New Drug (IND) clearance to atai Life Sciences, to conduct a clinical DDI study of PCN-101 (R-ketamine). The DDI trial will complement an existing Phase IIa trial in treatment-resistant depression (TRD) recently initiated in Europe.

The unique properties of PCN-101 could offer a differentiated profile to currently available antidepressants, addressing significant patient needs, including the potential of rapid action and anti-suicidal effect. Rapid onset of action is particularly important in this patient population, but frontline selective serotonin reuptake inhibitors (SSRIs) can take up to 12 weeks before providing maximal benefit, while suicidality affects as much as 30% of treatment-resistant depression (TRD) patients at least once during their lifetime.

“We see great promise in PCN-101 as a potentially rapid-acting anti-depressant with a more favorable safety and tolerability profile than S-ketamine, which could enable at-home use,” said Florian Brand, CEO and Co-Founder of atai Life Sciences. “With today’s IND clearance, we are excited to continue assessing the therapeutic potential of PCN-101 in the U.S., where, like elsewhere in the world, many patients struggle with treatment-resistant depression and desperately need innovative therapeutic options.”

It is estimated that around 100 million people live with TRD globally, representing a third of people with depression, who are undertreated or unresponsive to available treatment options. TRD has a severe impact on patients, families and caregivers, as well as healthcare systems.

“TRD represents a large percentage of people with severe, difficult to treat depression who have failed to sufficiently respond to at least two different antidepressant treatments,” explained Terence Kelly, PhD, CEO of Perception Neuroscience, the atai Life Sciences platform company conducting the trials. “We believe that PCN-101 has the potential to offer a differentiated therapeutic effect, in terms of both efficacy and ease of administration, for clinicians and patients, as a potentially rapid-acting antidepressant. We look forward to progressing its clinical development.”

 Ana Ovey

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