Peter Thiel-Backed Psychedelic Company Gets FDA Approval to Study Ketamine Treatment
The U.S. Food and Drug Administration has cleared German psychedelic startup Atai Life Sciences to conduct a clinical trial of a non-psychedelic form of ketamine for treatment-resistant depression.
The company will study arketamine, an enantiomer of ketamine, the FDA-approved dissociative anesthetic that is used for general and off-label anesthesia as a popular treatment for depression.
The promise of Arketamine is that it does not appear to produce a psychedelic experience while providing rapid antidepressant effects. If proven in clinical trials, arketamine could be a new drug for people with treatment-resistant depression and safe enough to use at home, not in a clinic under the supervision of a doctor like ketamine and Spravato, another form of the drug that has been approved by the FDA.
Atai’s majority-owned subsidiary, Perception Neuroscience, will launch the first in a series of arketamine clinical trials early this year in the United States. The first trial will be a drug interaction study.
Florian Brand, CEO and co-founder of Atai, which is backed by billionaire Peter Thiel and listed on Nasdaq, says that while trials show successful arketamine is a fast-acting antidepressant safe enough for home use, he “would be a great game changer for patients.
Perception Neuroscience has already launched two studies on arketamine in Europe.
The Phase I trial, which was conducted in 58 adults who received different doses of an intravenous infusion of arketamine in February, found that their compound, which they call PCN-101, was “safe and well tolerated.” »At all doses up to 150 mg. Participants did not report any serious side effects. The second step in the study compared PCN-101 to S-ketamine, which is the ingredient in Spravato. The results showed that Perception’s compound required significantly higher doses to induce psychedelic experiences similar to S-ketamine.
In September, Perception received approval to initiate a phase IIa, double-blind, placebo-controlled trial in patients with treatment-resistant depression in Europe. The study enrolled 93 patients who will receive a placebo, a 30 mg dose or a 60 mg dose of arketamine, which will be administered intravenously. The trial will investigate whether the drug is safe and effective in reducing depressive symptoms. The results are expected to be ready by the end of 2022.
Terence Kelly, CEO of New York-based Perception Neuroscience, says he is encouraged by the progress of arketamine through the regulatory process. “We believe that PCN-101 has the potential to provide a differentiated therapeutic effect, in terms of efficacy and ease of administration, for clinicians and patients,” Kelly said in a statement.
Srinivas Rao, Atai’s chief medical officer, says the psychedelic experience is important for many drugs the company is researching, but the non-psychedelic properties of arketamine make it a potential disruptive drug for treatment-resistant depression.
“At home, that’s the key,” says Rao. “Everything we look at, like psilocybin, needs to be done in the doctor’s office. This is obviously important for these compounds. But if we can get something that can be administered at home as a fast acting agent, that’s a much larger potential market and certainly broadens the appeal of the compound.
Big Pharma has already taken an interest in arketamine. In March 2021, Otsuka Pharmaceutical announced a $ 20 million license agreement to develop and market Perception’s arketamine compound in Japan as a potential treatment for major depressive disorder and treatment-resistant depression. Otsuka will have the exclusive rights to PCN-101 in Japan. If Otsuka is successful in bringing the drug to market, Perception will collect royalties from the sales.
The opportunity for a successful new drug to treat conditions such as depression, anxiety, and post-traumatic stress disorder is enormous. Prescription sales for depression are estimated at $ 50 billion per year worldwide, while the mental health market accounts for approximately $ 100 billion in annual sales. While biotech analysts say FDA-approved psychedelic-assisted therapy could generate $ 10 billion in annual sales by targeting the treatment-resistant depression subcategory, the real opportunity lies in replacing drugs like Prozac, Zoloft and other selective serotonin reuptake inhibitors.
It is estimated that 100 million people suffer from treatment-resistant depression worldwide, which represents a significant market for arketamine.
“What excites us, certainly, is what you call the blockbuster potential,” Brand says. “We are really interested in the big unmet needs, the big markets, the big opportunities. “
Atai is also the largest investor in Compass Pathways, a UK-based clinical stage company developing a patented form of psilocybin for use in conjunction with treatment for treatment-resistant depression. In November, the highly anticipated FDA-approved Compass Pathways Phase 2b clinical trial found that patients who took a single psychedelic dose of psilocybin, the main ingredient in ‘magic mushrooms’, in conjunction with therapy reported an almost immediate and significant reduction in depressive symptoms that lasted for weeks compared to patients who received a 1 mg dose, which is so small that it is essentially a placebo.
Atai, through another majority-owned subsidiary, is trying to develop a suite of second-generation psychedelics that offer a shorter two-hour trip.
Brand says that when it comes to treatments involving a psychedelic experience, the length of the psychedelic experience itself is a barrier to mainstream adoption.
“We’re all scale driven,” says Brand.
By modifying the psychedelic molecules to shorten the trip, more patients could try it and insurance companies could be more willing to cover the treatments.
Brand and many others in psychedelic medicine believe that travel-free therapy will have a big place in the future of the industry.
“We have a vision for precision psychiatry,” says Brand. “Ultimately, the goal is to identify which type of treatment is right for which patient. Not everyone will necessarily always want to use psychedelics like psilocybin. For some, this may be the appropriate treatment, but it is not really feasible for everyone.
Rao says the future is in the choices. Finding a drug that helps patients with treatment-resistant depression is particularly difficult since these patients have tried many different drugs without success. About 30% of people with depression find no success with available treatments. Rao says if arketamine is approved, it would become another tool that doctors can use.
“It depends on where you are in the process of your illness, you may need esketamine, or you may need psilocybin or DMT, or something else to induce and then you can. maintain with arketamine, ”says Rao. “But we don’t yet know how things are going to move.”