Cybin Expects Key Phase III Depression Trial Results This Quarter

Key Points

• Helus Pharma expects results from its APPROACH Phase III trial of 003 for major depressive disorder later this quarter. The study tests the treatment as an add-on to patients’ existing antidepressants.
• In APPROACH, patients receive two doses before the primary efficacy assessment at six weeks; a 12-week secondary endpoint will assess durability. A second Phase III trial, EMBRACE, is also underway, with timing guidance expected as enrollment progresses.
• Helus anticipates filing for approval of 003 in 2028 and plans to begin a Phase II anxiety study of 004 next year. CEO Michael Halstead said the company had about $165 million on its balance sheet and was funded through near-term milestones.

Helus Pharma expects results from the first Phase III trial of its experimental adjunctive treatment for major depressive disorder later this quarter, CEO Michael Halstead said at the Guggenheim Healthcare Innovation Conference.

The company’s 003 program, a deuterated psilocin treatment, is being studied in patients who remain on their existing antidepressants. Enrollment in the first Phase III trial, called APPROACH, was completed in July, and Halstead said the process was proceeding according to plan.

“We are on track for our expected data readout later this quarter,” Halstead said. He did not provide a more specific date or an update on the database lock.

Phase III design and safety

Patients in the trial must have been on a stable dose of antidepressant medication for at least four weeks and remain on that background therapy throughout the study, Halstead said. He cautioned that the adjunctive setting differs from trials in which patients stop their antidepressants or have treatment-resistant depression.

In Phase II, patients received one dose at the start of the study, with the primary endpoint measured at three weeks. They received a second dose after that measurement. Halstead said the study showed efficacy and durability out to a year following two doses, though he said those results would need to be borne out in Phase III.

The Phase III design incorporates both doses before the primary endpoint: patients are treated at the start and again at three weeks, with efficacy measured at six weeks. A secondary endpoint at 12 weeks will provide additional durability data without another dose, he said.

Halstead described Phase II adverse events as mild to moderate and primarily transitory on the treatment day, including nausea, headache and elevated blood pressure. Asked about suicidality in depression trials, he said it was not observed in the company’s Phase II study. The Phase III trials have a safety data monitoring board that regularly evaluates safety reports, he added.

Broader development plans

A second Phase III trial, EMBRACE, is ongoing. It includes a 16-milligram arm, a placebo arm and an 8-milligram arm intended to serve as an active comparator and provide information about dose response and functional unblinding, Halstead said. The company has not provided a specific readout date but expects to offer more precise timing after it has more enrollment information.

Patients from both Phase III studies can enter EXTEND, a 52-week blinded safety study in which they can receive up to three additional doses. Halstead said the study should also provide information about durability and dosing.

Helus anticipates filing a new drug application for 003 in 2028 and also anticipates approval that year, Halstead said. The program has Breakthrough Therapy Designation, and the company would expect a rolling submission.

Anxiety program and finances

Helus also plans to start a Phase II monotherapy study of its 004 program, a deuterated DMT treatment for generalized anxiety disorder, in the first quarter of next year. The trial targets 144 patients and will compare a 30-milligram dose with placebo, Halstead said. The treatment is administered by intramuscular injection in a clinic.

The company reported approximately $165 million on its balance sheet in its latest filed financials, according to Halstead. He said Helus was capitalized through near-term milestones, including the APPROACH readout and the start of the 004 trial, but had not yet provided long-term cash runway guidance.

About Cybin (NASDAQ:HELP)

Cybin Inc is a clinical-stage biopharmaceutical company focused on developing psychedelic-based therapeutics for mental health conditions. The company's research programs are designed to address disorders such as major depressive disorder and other conditions where existing treatments may not provide adequate relief.

Cybin's development platform has included investigational compounds such as CYB003, a deuterated psilocybin analog being studied for depression, and CYB004, an investigational N,N-dimethyltryptamine (DMT) formulation being evaluated for potential use in mental health treatment.

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