deuterated dimethyltryptamine (HLP004) / Helus Pharma - LARVOL DELTA

Safety, pharmacokinetics, and pharmacodynamics of intravenously administered deuterated N,N-dimethyltryptamine (CYB004) in healthy volunteers. (PubMed, J Psychopharmacol) - "CYB004 demonstrated PD effects comparable to DMT. However, CYB004 demonstrated an extended duration of these effects due to reduced clearance, while maintaining an acceptable safety profile at clinically relevant exposures despite PK variability."

Clinical • Journal • PK/PD data • CNS Disorders • Mental Retardation • Psychiatry

A Study of a N, N-dimethyltryptamine (DMT) Analog (CYB004) in Participants With Generalized Anxiety Disorder (GAD) (clinicaltrials.gov) - P2 | N=36 | Completed | Sponsor: Cybin IRL Limited | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • General Anxiety Disorder • Mood Disorders • Psychiatry

A Study of a N, N-dimethyltryptamine (DMT) Analog (CYB004) in Participants With Generalized Anxiety Disorder (GAD) (clinicaltrials.gov) - P2 | N=36 | Active, not recruiting | Sponsor: Cybin IRL Limited | Recruiting ➔ Active, not recruiting | Trial completion date: Feb 2025 ➔ Sep 2026 | Trial primary completion date: Nov 2024 ➔ Oct 2025

Enrollment closed • Trial completion date • Trial primary completion date • CNS Disorders • General Anxiety Disorder • Mood Disorders • Psychiatry

The Phase 2 CYB004 study is a randomized, double-blind study evaluating the safety and efficacy of CYB004 in participants with generalized anxiety disorder, with concomitant antidepressant/anxiolytic treatment and co-morbid depression allowed. (Cybin Press Release) - "Patient enrollment is expected to be completed this month."

Enrollment status • General Anxiety Disorder

Cybin Reports Third Quarter Fiscal Year 2025 Financial Results and Recent Business Highlights (Businesswire) - "CYB004: Phase 2 proof-of-concept study in generalized anxiety disorder ('GAD') is underway...The Phase 2 study is a randomized, double-blind study evaluating the safety and efficacy of CYB004 in participants with GAD, with concomitant antidepressant/anxiolytic treatment and co-morbid depression allowed; The Phase 2 study is being conducted at sites in the U.S., with topline safety and efficacy results expected in the first half of 2025."

P2 data • General Anxiety Disorder

A Study of a N, N-dimethyltryptamine (DMT) Analog (CYB004) in Participants With Generalized Anxiety Disorder (GAD) (clinicaltrials.gov) - P2 | N=36 | Recruiting | Sponsor: Cybin IRL Limited | Not yet recruiting ➔ Recruiting | Phase classification: P1/2 ➔ P2

Enrollment open • Phase classification • CNS Disorders • General Anxiety Disorder • Mood Disorders • Psychiatry

A Study of a N, N-dimethyltryptamine (DMT) Analog (CYB004) in Participants With Generalized Anxiety Disorder (GAD) With Depressive Symptoms (clinicaltrials.gov) - P1/2 | N=36 | Not yet recruiting | Sponsor: Cybin IRL Limited | Phase classification: P1b/2a ➔ P1/2

Phase classification • CNS Disorders • General Anxiety Disorder • Mood Disorders • Psychiatry

A Study of a N, N-dimethyltryptamine (DMT) Analog (CYB004) in Participants With Generalized Anxiety Disorder (GAD) With Depressive Symptoms (clinicaltrials.gov) - P1/2 | N=36 | Not yet recruiting | Sponsor: Cybin IRL Limited

New P1/2 trial • CNS Disorders • General Anxiety Disorder • Mood Disorders • Psychiatry

Early Clinical Development of a Deuterated N,N-DIMETHYLTRYPTAMINE (DMT) Analog for the Treatment of Mental Health Conditions (ACNP 2023) - "Cybin is developing CYB004, a deuterated analog of DMT and has designed and conducted a series of clinical studies (CYB004E Parts A, B, and C) that have explored the PK, PD, and safety of DMT and CYB004... Escalating doses of DMT were well tolerated with high variability in plasma levels. Robust psychedelic effects were produced and were related to the rate at which Cmax was achieved. A bolus + infusion dosing regimen may provide sustained therapeutically relevant psychedelic effects over an extended period."

Clinical • CNS Disorders

Preclinical Characterization of CYB004: A Novel, Deuterated N,N-Dimethyltryptamine (DMT) Analog for the Potential Treatment of Generalized Anxiety Disorder (GAD) (ACNP 2023) - "Data from these studies confirm that deuteration did not impact the pharmacology and in vivo profile of CYB004, but deuteration potentially offers the ability to extend the PK profile of DMT and enhance treatment outcomes."

Preclinical • CNS Disorders • Depression • General Anxiety Disorder • Major Depressive Disorder • Mood Disorders • Psychiatry

Cybin Announces Grant of Two New United States Patents Protecting its Deuterated DMT Program (Businesswire) - "Cybin Inc...announced that the United States Patent and Trademark Office has issued two patent grants that offer protection for its deuterated N, N-dimethyltryptamine ('DMT') program. The granted patents protecting the Company’s deuterated DMT program are: United States patent no. 11,771,681, which provides composition of matter protection for certain deuterated analogs of DMT; and United States patent no. 11,773,062, which provides protection for the medical use and the novel, efficient and scalable synthesis of certain analogs of DMT. Cybin’s proprietary novel deuterated DMT compounds, CYB004 and SPL028, are each currently in Phase I clinical trials....Topline data readouts from both studies are expected in Q4 2023."

P1 data • Patent • CNS Disorders • General Anxiety Disorder

Cybin Inc. Reports Fiscal Year 2023 Financial Results and Recent Business Highlights (Businesswire) - "Upcoming 2023 Milestones, CYB003: Deuterated psilocybin analog for the potential treatment of MDD: Completion of CYB003 dosing in MDD cohorts expected in Q3 2023. Topline efficacy data from the ongoing Phase 2 MDD study expected in Q3/Q4 2023. FDA submission of CYB003 Phase 1/2a data for end of Phase 2 meeting expected in Q4 2023. CYB004: dDMT for the potential treatment of Generalized Anxiety Disorder. Phase 1 topline data readout, including safety, dosing, and pharmacokinetic and pharmacodynamic data, expected in Q3/Q4 2023."

FDA event • P1 data • Trial status • CNS Disorders • Depression • General Anxiety Disorder • Major Depressive Disorder • Mood Disorders

Cybin Initiates First-in-Human Dosing of CYB004 in Phase 1 Clinical Trial (Businesswire) - "CYB004, a deuterated dimethyltryptamine ('dDMT') molecule, has potential to overcome existing limitations of DMT and is protected by a composition of matter patent through 2041...the first participants have been dosed with CYB004 in its ongoing three-part Phase 1 clinical trial evaluating intravenous N,N-dimethyltryptamine ('V DMT') and CYB004 in healthy volunteers. As expected, robust psychedelic effects were seen within two minutes, reaching a peak at about thirteen minutes. No safety concerns were reported from these initial participants....the Company anticipates a topline data readout from the Phase 1 trial in the third quarter of calendar year 2023."

P1 data • Patent • Trial status • CNS Disorders • Depression • Major Depressive Disorder