FDA grants IND clearance for ketamine study

The FDA has granted an investigational drug designation to PCN-101 ahead of a clinical study to be conducted by atai Life Sciences, according to a company release.

The open-label, two-cohort, fixed-sequence, drug-drug interaction study will evaluate the effects of CYP450 inhibition on the pharmacokinetics of PCN-101 (R-ketamine) in otherwise healthy adults diagnosed with treatment-resistant depression (TRD). It will be conducted through atai’s platform company, Perception Neuroscience.

“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.”

In preclinical animal model studies, R-ketamine demonstrated potential for greater strength, safety and tolerability than S-ketamine, which could potentially lead to at-home use of the drug.

In addition, a third-party, open-label study revealed PCN-101 to possess quick and sustainable antidepressant effects as well as lessened dissociative consequences in patients with TRD administered a single intravenous dose of an alternate formulation of R-ketamine.

The upcoming study will advance alongside an existing phase 2a proof-of-concept trial in TRD, recently initiated in Europe.

In addition, atai is expected to commence a bioavailability study in 2022, designed to bridge the IV brand of PCN-101 to a subcutaneous model with the potential to facilitate self-administration.