InDex Pharmaceuticals – Positive feedback from Japanese authorities (PDMA) for Cobitolimod.
Meet and ask questions to Acting CEO Johan Gileus from InDex Pharmaceuticals and CMO Anders Bröjersen with an update on the announcement regarding Cobitolimod in Japan.
The phase 3 program – Conclude, consists of two sequential global induction studies and a year-long maintenance study. The first phase 3 study of Conclude is ongoing and results are expected during H2 2023.
The second phase 3 study of Conclude is expected to start after a positive read-out of the first study.
PDMA didn’t require additional studies prior to including Japanese patients in the global phase III study. In addition, the PMDA stated overall acceptance for the non-clinical package as well as the study design of the phase III program.
Pharmacokinetic data for cobitolimod in Japanese patients will have to be collected before applying for market approval but can be conducted during the remaining phase III program.
This is a unique decision by PDMA and indicates a great potential for Cobitolimod in Japan.
We expect the presentation to last 25 min. and then open for questions.
InDex Pharmaceuticals in brief
InDex is a pharmaceutical development company focusing on immunological diseases where there is a high unmet medical need for new treatment options. The company’s lead asset is the drug candidate cobitolimod, which is being evaluated in the phase III study CONCLUDE as a novel treatment of moderate to severe ulcerative colitis – a debilitating, chronic inflammation of the large intestine. InDex has also developed a platform of patent-protected discovery stage substances, so called DNA based ImmunoModulatory Sequences (DIMS), with the potential to be used in the treatment of various immunological diseases.
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