Dimerix (ASX:DXB) has confirmed that the first clinical trial site in Japan is now open for recruitment, triggering the first development milestone payment of ¥400 million (~AU$4.3 million) from FUSO Pharmaceutical Industries, the exclusive licensee of DMX-200 for FSGS in Japan.
Dimerix says the first clinical trial site was the final step required before recruiting patients in Japan, following prior approval by the Japanese Pharmaceutical and Medical Device Agency (PMDA, the Japanese regulatory agency), receipt of ethics approval, and finalisation and agreement of the Clinical Trial Agreements with the clinical sites.
“Opening the first clinical site in Japan is another major step forward for our global ACTION3 clinical program, as we aim to bring much-needed and new treatments to patients with FSGS around the world. This milestone reflects the strength of our data to date, the rigour of our clinical trial design, and the expertise from our local partner in Japan, FUSO,” said Dimerix CEO and managing director Dr Nina Webster.
FUSO will be responsible for clinical development costs in Japan, submission and maintenance of the regulatory dossier with the PMDA, as well as all sales and marketing activities in Japan, while Dimerix will continue to fund and execute the global ACTION3 Phase 3 study for DMX-200 in FSGS patients outside of Japan. The company said it expects to receive the First Development Milestone Payment of ¥400 million (~AU$4.3 million) within 30 days from FUSO.