2 Psychedelics Companies Tout Advanced Clinical Trials, Progress With Key Products

Two psychedelics companies have shared their updates and key milestones to be reached this 2023.

The 5-MeO-DMT Business

Clinical-stage biopharma company GH Research PLC GHRS has received initial regulatory and ethical approvals to commence a multi-site Phase 2b trial for its lead product candidate, GH001.

The product, formulated for 5-MeO-DMT administration via a proprietary inhalation approach, will most likely begin a trial in the first quarter of 2023.

See Also: GH Research Shares Financial Results

The company’s lead compound had previously completed two Phase 1 healthy volunteer clinical trials and a Phase 1/2 clinical trial in patients with treatment-resistant depression (TRD). More than 87% of patients with TRD were brought into an ultra-rapid remission with a single dose, no serious adverse events and good tolerability reported.

GH has also created an aerosol delivery device for GH001, a combination for which the company expects to submit a Phase 1 clinical trial IND application in the third quarter of 2023.

Meanwhile, GH002 is an injectable version of 5-MeO-DMT and is now being assessed in a dose-ranging Phase 1 trial in healthy volunteers for which completion is expected in Q4 of 2023. A third proprietary drug called GH003 is an intranasal 5-MeO-DMT candidate currently in the preclinical stage.

Racemic Ketamine On The Table

Specialty ketamine company PharmaTher Holdings Ltd. PHRRF is advancing its proprietary product, KETARX, as a potential treatment for several mental health, neurological and pain disorders.

PharmaTher CEO Fabio Chianelli says it “paves the way for potential near-term commercialization opportunities” in 2023 and that the company will focus on seeking “one or more” FDA drug approvals via the Abbreviated New Drug Application (ANDA) and 505(b)(2) regulatory pathways.

PharmaTher also plans on “advancing late-stage clinical studies, and attracting strategic partnerships that will unlock the value of our product pipeline and drug delivery technologies," Chianelli added.

Racemic ketamine was approved by the FDA in 1970 and is clinically used for analgesia, sedation, and anesthetic induction.

PharmaTher expects KETARX to gain FDA approval via the ANDA regulatory pathway in the first half of 2023. The drug would then be sold in dosage forms at an average wholesale price between $25 and $40 per unit.

On the other hand, PharmaTher is on its way to potentially achieve approval for a Phase 3 KETARX clinical trial for the treatment of levodopa-induced dyskinesia in Parkinson’s, following a Phase 1/2 study data showing ketamine’s safety and tolerability with clinically meaningful efficacy; and for a Phase 2 study assessing proprietary ketamine for the treatment of ALS.

In addition to all this, PharmaTher currently holds no less than four orphan drug designations granted by the FDA for KETARX including prevention of Ischemia-reperfusion injury from organ transplantation; treatment of Status Epilepticus; treatment of Amyotrophic Lateral Sclerosis (ALS); and treatment of Complex Regional Pain Syndrome (CRPS).

The company also holds rights to a US patent titled “Compositions and Methods for Treating Motor Disorders” covering ketamine for the potential treatment of Parkinson’s and motor disorders causing involuntary or uncontrollable body movement or actions.

Photo: Benzinga edit with photo by Olia Danilevich on Pexels.