InDex Pharmaceuticals has announced that the company has received positive feedback from the Japanese regulatory authority, the Pharmaceuticals and Medical Devices Agency (PMDA), regarding the clinical development plan for a future marketing authorization application for the company’s TLR9 agonist cobitolimod, for the treatment of moderate to severe left-sided ulcerative colitis. The PMDA has accepted enrolment of Japanese ulcerative colitis patients in the second global phase III induction study, without performing specific Japanese studies prior to study start.
“We are very pleased that the PMDA supports our development plan for cobitolimod in Japan, and that they agreed to include Japanese patients in the second phase III induction study with cobitolimod, without conducting specific studies in Japanese subjects,” said Johan Gileus, acting CEO of InDex Pharmaceuticals. “This is a unique decision by PMDA, indicating great potential for cobitolimod and a need for new treatment options that can help more patients with moderate to severe ulcerative colitis return to a normal life. In addition, the positive feedback from PMDA is advantageous for discussions with potential candidates for strategic collaborations in Japan.”
Disclaimer: HC Andersen Capital receives payment from InDex Pharmaceuticals for a DigitalIR/Corporate Visibility agreement.