PCN-101 was recently awarded Investigational New Drug (IND) status by the U.S. Food and Drug Administration. It’s a for treating the patients with treatment resistant depression.
Atai’s drug got permission to proceed with its new drug for treatment resistant depression.
On Wednesday, atai Life Sciences announced its plan to begin a clinical drug-drug interaction (DDI) study via its majority-owned subsidiary Perception Neuroscience starting early in 2022.
Evaluating the pharmacokinetics of its Investigational New Drug, PCN-101 (R-ketamine), this trial will be an expansion on current efforts to assess the efficacy of this drug against treatment resistant depression (TRD). PCN-101 was recently awarded Investigational New Drug (IND) status by the U.S. Food and Drug Administration.
PCN-101 could offer a differentiated profile to currently available antidepressants and address key patient needs. The rapid action of this treatment is of particular interest, as the many options presently available to patients suffering from depression and treatment resistant depression utilize selective serotonin reuptake inhibitors (SSRIs). While these drugs have been shown to be effective, they can take up to three months before achieving maximum benefit for the patient.
The efficacy of SSRIs also falters against TRD, and they fail to assist the approximately 30% of treatment resistant depression patients that are affected by suicidality. As there are an estimated 100 million or more people worldwide that struggle with TRD, that’s at least 30 million people who experience suicidality with few treatment options, along with the resultant strain on caregivers, healthcare systems, and families.
What is Treatment Resistant Depression?
“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,” Perception Neuroscience CEO Terence Kelly, Ph.D. explained in today’s press release. “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.”
The fast-acting PCN-101 treatment not only has the potential to surpass SSRIs in speed of efficacy but may also be more effective against TRD. This projection is supported by preclinical animal models, as well as a third-party, open-label study where rapid and long-lasting antidepressant responses in treatment resistant depression patients were induced after only a single intravenous dose of another form of R-ketamine.
Furthermore, R-ketamine has been shown to potentially offer a safer, more tolerable and more durable treatment alternative to S-ketamine.
“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 atai CEO and Co-founder Florian Brand. “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.”
Perception Neuroscience and atai Life Sciences plan to advance this study alongside their Phase IIa proof-of-concept trial in treatment resistant depression currently underway in Europe. They also look forward to running a bioavailability study this year to see if they can transition their present intravenously-delivered formulation to one amenable to subcutaneous delivery and therefore at-home self-administration.
