Cybin said the Japan Patent Office has granted JP patents 2023-500532 and 2023-533436 to the company for its DMT program.
The patents include protection for a synthesis method for the preparation of DMT and dDMT and injectable formulations within the company’s proprietary DMT program. The formulations are in clinical development for the treatment of generalized anxiety disorder.
The patents are expected to provide exclusivity until at least 2040 and 2041, respectively, according to the company.
“The issuance of these patents by the Japan Patent Office serves to further strengthen and broaden our intellectual-property portfolio in key global markets, as we advance our clinical programs,” Cybin CEO Doug Drysdale said in a news release. “Japan is a major pharmaceutical market, and the patents serve as further validation of our research-and-development efforts to bring improved treatment options globally for a multitude of mental health disorders.
“Vigorously protecting our proprietary work is a strategic priority for us, and we are delighted that these patents add to our existing U.S. and European patent portfolio and provide protection for our proprietary DMT program in another important region.”
In January, the company announced that the U.S. Food and Drug Administration cleared its investigational new-drug application for CYB004, its proprietary dDMT molecule in development for the treatment of generalized anxiety disorder.
The clearance allows the company to proceed with its plans to initiate a Phase 2a study of CYB004 in Q1 2024.
The Phase 2a study will be a randomized, double-blind, active-controlled trial to assess the preliminary clinical efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of CYB004 in participants with generalized anxiety disorder, according to Cybin.
In January, Cybin announced positive safety, pharmacokinetic and pharmacodynamic data from its Phase 1 studies of CYB004 (intravenous) and SPL028 (intravenous and intramuscular) in healthy volunteers.
CYB004 and SPL028 are proprietary deuterated DMT molecules within the company’s DMT program in development for the treatment of generalized anxiety disorder.