Dimerix (ASX:DXB) has announced that patients who complete the ACTION3 Phase 3 trial and its open-label extension may be allowed to continue receiving the investigational candidate DMX-200 through post‑trial access pathways in key territories.
The program is intended to bridge care for people with focal segmental glomerulosclerosis who, together with their treating physicians, determine ongoing therapy is appropriate, and no suitable alternatives exist.
Depending on local rules, access will be provided through mechanisms such as expanded access or compassionate use, with participating commercial partners handling arrangements and supply in their territories and Dimerix covering regions without a partner, the company said. Dimerix also clarified that these pathways do not equate to regulatory approval and that data collection for patients in the program will focus mainly on safety.
The move follows the pivotal ACTION3 trial design, which randomises patients already on an angiotensin II receptor blocker to receive DMX-200 or placebo over two years to assess reductions in proteinuria and kidney function. DMX-200 is a CCR2 antagonist.
“We are committed to ensuring that patients with FSGS, who have participated in our clinical program, have the opportunity to continue treatment with DMX-200 where appropriate,” said Dr David Fuller, Dimerix Chief Medical Officer.
