FDA clears Cybin for Phase 2 DMT study

This trial will be conducted at study sites in the United States.

Cybin Inc. (NYSE: CYBN) announced that the U.S. Food and Drug Administration cleared its investigational new drug (IND) application for CYB004, a proprietary deuterated dimethyltryptamine (DMT) molecule in development for the treatment of Generalized Anxiety Disorder (GAD).

With this clearance, Cybin can move forward with its plans to initiate a Phase 2a study of CYB004 in the first quarter of 2024. Cybin said in a statement that the phase 2a study will be a randomized, double-blind, active-controlled trial to assess the preliminary clinical efficacy, safety, tolerability, pharmacokinetics (how the drug is processed by the body), and pharmacodynamics (how the drug reacts and the effect on the body) of CYB004 in participants with GAD.

This trial will be conducted at study sites in the United States.

“With the recent positive topline results from two Phase 1 studies of our proprietary deuterated DMT molecules, CYB004 and SPL028, we are well-positioned to initiate a Phase 2a study of CYB004 in GAD this quarter,” CEO Doug Drysdale said.

“From our extensive portfolio of DMT and deuterated DMT datasets across five completed clinical studies, we have gathered important insights on dosing and preliminary efficacy signals in both depression and anxiety that will inform our next steps. Exploratory data from our completed Phase 2a study of SPL026 (IV DMT) have shown that SPL026 reduced symptoms of anxiety in patients with major depressive disorder, which further serves to de-risk the development of deuterated DMT in anxiety disorders as we continue to evaluate the efficacy and safety of CYB004.”

Phase 1 Results

Recently Cybin reported that results from the Phase 1 studies in the CYB004 and SPL028 programs demonstrated pharmacokinetic (PK) and pharmacodynamic (PD) profiles with the potential to bridge data across these molecules, and the PK profiles for both molecules demonstrated concentrations in the effective range.

The company said that both IV (CYB004 and SPL028) and intramuscular (SPL028) administration routes were safe and well tolerated, with the potential for intramuscular (IM) dosing to provide a more convenient dosing method for patients.

IM dosing of SPL028 produced robust psychedelic effects lasting a short duration in the majority of subjects, a finding that supports IM administration as a well-tolerated and effective dosing method that is highly scalable.

“Importantly, these are the first-in-human studies of deuterated DMT in healthy participants,” Drysdale said. “We are pleased that both the IV and IM administrations produced robust psychedelic effects and were safe and well-tolerated. We are especially encouraged that the IM route produced psychedelic effects in the majority of subjects, with a short-duration psychedelic experience from a single administration of SPL028.”

Debra Borchardt

Debra Borchardt is the Co-Founder, and Executive Editor of GMR. She has covered the cannabis industry for several years at Forbes, Seeking Alpha and TheStreet. Prior to becoming a financial journalist, Debra was a Vice President at Bear Stearns where she held a Series 7 and Registered Investment Advisor license. Debra has a Master's degree in Business Journalism from New York University.


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