Connect with us


FDA clears Cybin for Phase 2 DMT study

Cybin Inc. (NYSE: CYBN) announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for CYB004,…



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

With this clearance, Cybin can move 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, PK and PD 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,” said Doug Drysdale, Chief Executive Officer of Cybin. “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 IM (SPL028) administration routes were safe and well-tolerated, with the potential for IM dosing to provide a more convenient dosing method for patients when compared to IV infusion. 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.

“The positive data from our Phase 1 studies of CYB004 and SPL028 are highly encouraging with the combined data from these studies enabling us to prioritize our 2024 development plan for our deuterated DMT program. Importantly, these are the first-in-human studies of deuterated DMT in healthy participants. 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,” said Drysdale. “These results for IM dosing of deuterated DMT are highly promising and will help inform dosing in future clinical trials, saving time and resources by eliminating the need for further formulation studies of other methods such as subcutaneous dosing.”

The post FDA clears Cybin for Phase 2 DMT study appeared first on Green Market Report.

Read More