FDA Green-Lights Expedited Review Path for Cybin’s CYB003 Psilocybin Molecule

Cybin is developing the proprietary deuterated psilocybin analog for the adjunctive treatment of major depressive disorder.

The U.S. Food & Drug Administration has granted breakthrough-therapy designation to Cybin for its novel psychedelic molecule, CYB003.

Cybin is developing the proprietary deuterated psilocybin analog for the adjunctive treatment of major depressive disorder, or MDD.

Coinciding with the FDA news, Cybin said its Phase 2 trial of CYB003 “demonstrated robust and sustained improvement” in depression symptoms at four months, with 75% of participants receiving two 16-milligram doses achieving remission and no longer showing signs of depression.

“These significant milestones reflect the company’s commitment to advancing cutting-edge treatment options for MDD, marking a transformational moment in the pursuit of regulatory approval,” the company said in a news release.

The breakthrough-therapy designation is a means “to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s),” the FDA explains on its website.

“BTD provides an expedited review pathway, as well as increased access to FDA guidance on trial design, with the potential to reduce drug-development timelines,” Cybin added.

‘Streamlined Review Process’

If approved by the FDA, CYB003 would be the first known adjunctive psychedelic-based therapeutic for the treatment of MDD.

“The designation of CYB003 as a breakthrough therapy acknowledges the significant unmet medical need for more effective treatments of MDD and supports CYB003’s potential for significant improvements over existing therapies,” the company said in a news release. “BTD serves as validation of the company’s progress to date and is expected to accelerate Cybin’s mission to advance its proprietary next-generation treatment towards new drug approval on an expedited basis.”

The designation is supported by the positive top-line results from the company’s Phase 2 study of CYB003 in MDD, which demonstrated an improvement in depression symptoms superior to approved antidepressants and recently reported data with other psychedelics, according to the company.

Doug Drysdale
Cybin CEO Doug Drysdale

“It is a testament to the hard work and dedication of the entire Cybin team that we have accomplished so much so quickly,” Cybin CEO Doug Drysdale said. “The granting of breakthrough-therapy designation by the FDA underscores the potential of CYB003 to fill a gap in the treatment landscape for MDD and serves to expedite and de-risk our development program going forward.

“This designation provides for a streamlined review process and enhanced engagement with the FDA. With the robust durability data from our Phase 2 study in hand, we are ready to move forward expeditiously. We are grateful for the opportunity to accelerate the development and regulatory review process that this designation affords, as we prepare to advance CYB003 toward a Phase 3 pivotal trial around mid-year.”