Atai Life Sciences Archives - Medical Design Sourcing

Atai Life Sciences unit GABA Therapeutics upbeat about deuterated form of 1960s drug

The biopharma Atai Life Sciences (Nasdaq:ATAI) subsidiary GABA Therapeutics is sharing positive results from a Phase 1 study of GRX-917, a deuterated form of etifoxine, which the German firm Hoechst developed in the 1960s. Sanofi-Aventis eventually subsumed Hoechst in 2004.

Atai investigated the safety, tolerability and pharmacokinetic profile of orally administered GRX-917 in a Phase 1 study.

The company is developing GRX-917 for generalized anxiety disorder (GAD).

An improved safety profile than benzodiazepines?

The company believes the GRX-917 could have a better safety profile than traditional benzodiazepines.

“Based on etifoxine’s safety and efficacy profile, we believe GRX-917 will offer a differentiated treatment for GAD with fewer side effects—such as sedation, respiratory depression, and withdrawal,” said Dr. Mario Saltarelli, chief medical officer of GABA Therapeutics.

The company noted that the drug candidate was well tolerated.<…

Atai subsidiary wraps up enrollment for clinical study of r-ketamine

Mental health–focused biopharma Atai Life Sciences (Nasdaq:ATAI) recently completed enrollment in a Phase 2a study of PCN-101 (r-ketamine) for treatment-resistant depression.

The company’s Perception Neuroscience division expects top-line results from the trial before the end of 2022.

R-ketamine is an enantiomer of ketamine. Conversely, racemic ketamine is composed of equal amounts of s-ketamine and r-ketamine. We included r-ketamine in our list of emerging antidepressants.

Johnson & Johnson (NYSE:JNJ) has achieved intellectual property protection for S-ketamine and, in 2019, won FDA approval for s-ketamine for treatment-resistant depression.

The company notes that PCN-101 could be a potentially rapid-acting therapeutic for treatment-resistant depression (TRD) that can be administered at home.

[R-ketamine image courtesy of PubChem]

“We anticipate this therapy to be administered i…

Atai Life Sciences shares positive results from Phase 1 study of opioid use disorder

Berlin-headquartered Atai Life Sciences (Nasdaq:ATAI) is sharing positive initial results from a Phase 1 clinical study of KUR-101, an oral formulation of deuterated mitragynine, in patients with opioid use disorder.

Mitragynine is a primary active alkaloid of the kratom plant (Mitragyna speciosa).

Atai’s KUR-101 is an oral formulation of deuterated mitragynine. Atai subsidiary Kures is leading the development of the drug. Kures is a spin-out from Columbia University.

In its recent placebo-controlled Phase 1 study, the drug appeared to be safe and well-tolerated in most patients. In addition, the study found that KUR-101 led to minimal changes in respiratory rate.

Kratom is a controversial botanical. Native to Southeast Asia, kratom has been banned in various countries owing to its opioid-like effects. In 2016, the Drug Enforcement Agency in the U.S. announced its intent to schedule kratom, which it deemed to be an “imminent hazard to public safet…

Atai Life Sciences launches Phase 1 study of buccal and IV synthetic DMT

Atai Life Sciences (Nasdaq:ATAI) has dosed the first patient in a Phase 1 single-ascending-dose study focused on VLS-01, a synthetic form of N,N-dimethyltryptamine (DMT) for treatment-resistant depression (TRD).

While many companies in the psychedelic industry first focused on psilocybin, a growing number of players are beginning to explore the therapeutic potential of DMT, a short-acting naturally-occurring psychedelic.

The active component of the South American psychedelic brew ayahuasca, DMT, is a 5-HT2A receptor agonist like psilocybin and LSD.

Unlike other classic psychedelics, DMT is not orally active when administered alone. Ayahuasca contains a monoamine oxidase inhibitor to protect DMT from metabolism.

The clinical-stage company Algernon Pharmaceuticals (CSE:AGN; Frankfurt:AGW0; OTCQB: AGNPF), for instance, has commenced a Phase 1 study of IV DMT in patients ischemic stroke patients.

Although treatment-resistant depression lacks a …