InDex Pharmaceuticals updates the timeline of the phase III study CONCLUDE with cobitolimod
InDex Pharmaceuticals Holding today announced an update in the timing of the dose selection in the ongoing phase III study CONCLUDE with the drug candidate cobitolimod. The outcome of the dose selection is expected to be available Q4 2023. At that point in time InDex will have finalised the assessments of consequences on the overall development timeline including topline results in CONCLUDE.
“Patient recruitment for the global phase III study CONCLUDE is under way. However, as previously communicated, lingering post-pandemic effects, Russia’s invasion of Ukraine resulting in the need to find additional participating sites, as well as an increased competitive environment for clinical studies has resulted in a slower start up and lower patient recruitment rate than expected. We can now confirm that this unfortunately will result in a delay to the study timeline,” said Jenny Sundqvist, CEO of InDex Pharmaceuticals. “We are working hard together with our CRO to continuously assess what actions are required and implement measures to increase the patient recruitment rate going forward. We expect to present the outcome from the cobitolimod dose selection Q4 2023, after which we should have enough information to be able to present a new overall development timeline.”
The CONCLUDE study is a phase III study evaluating the first-in-class TLR9 agonist cobitolimod as a novel treatment for patients with moderate to severe left-sided ulcerative colitis. The study will include approximately 440 patients and is conducted at several hundred clinics in over 30 countries in Europe, the Americas and the Asia-Pacific region. When 30% of the patients in the study have been randomised, a dose selection will be performed in a blinded fashion to choose the best dose of either 250 or 500 mg cobitolimod. Following the blinded dose selection, new patients entering the study will be treated with the selected dose of cobitolimod or placebo.
InDex ended 2022 with a strong cash position of SEK 345m. The company forecasts that additional capital may be needed before study completion and will come back on this once the overall development timeline is confirmed.
Disclaimer: HC Andersen Capital receives payment from InDex Pharmaceuticals for a DigitalIR/Corporate Visibility agreement. /Claus Thestrup kl. 17.10 d. 27/01-2023
Flerie
InDex Pharmaceuticals 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 in late-stage clinical development for the 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. InDex is based in Stockholm, Sweden. The company’s shares (ticker INDEX) are traded on Nasdaq First North Growth Market Stockholm.
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