STOCKHOLM, Could 12, 2022 /PRNewswire/ — InDex Prescribed drugs Holding AB (publ) at the moment introduced that the corporate can be exhibiting on the Digestive Illness Week (DDW) Could 21-24, 2022 in San Diego. DDW is the world’s premier assembly for healthcare professionals, researchers and business within the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgical procedure.
InDex Prescribed drugs can be situated at sales space #1413 within the exhibition corridor, San Diego Conference Centre. InDex’s crew members can be current on web site to supply details about cobitolimod and the continued part III medical examine CONCLUDE, evaluating the Toll-like receptor 9 agonist cobitolimod as a novel therapy for reasonable to extreme left-sided ulcerative colitis. The examine will embrace roughly 440 sufferers and be carried out at a number of hundred clinics in over 30 international locations in Europe, the Americas and the Asia-Pacific area.
“DDW is a vital business {and professional} occasion, and we sit up for assembly healthcare professionals and different stakeholders with an curiosity in inflammatory bowel illness to debate our lead drug candidate cobitolimod and the part III examine CONCLUDE,” mentioned Johan Giléus, appearing CEO of InDex Prescribed drugs. “With cobitolimod we purpose to develop a novel, efficient and protected therapy to enhance the lives of sufferers affected by this debilitating illness.”
For extra data:
Johan Giléus, appearing CEO
Cellphone: +46 8 122 038 50
E-mail: [email protected]
Publication
The knowledge was submitted for publication by means of the company of the contact individual set out above at 11:00 CET on Could 12, 2022.
Concerning the CONCLUDE examine
CONCLUDE is a randomised, double-blind, placebo-controlled, medical part III examine to guage cobitolimod as a novel therapy for sufferers with reasonable to extreme left-sided ulcerative colitis with an insufficient response or failure to tolerate typical remedy, organic remedy or JAK inhibitors. The examine has been designed in session with each the US and European regulatory authorities, the FDA and EMA respectively. The induction examine will embrace roughly 440 sufferers, and the first endpoint can be medical remission at week 6, which is identical major endpoint as used within the profitable part IIb examine CONDUCT. Other than the dosing 250 mg given at baseline and week 3, which was the best dose and the one which confirmed the very best efficacy within the part IIb examine, the part III examine may also consider a better dose, 500 mg, in an adaptive examine design. Sufferers responding to cobitolimod within the induction examine can be eligible to proceed in a one-year upkeep examine, the place they are going to be handled with both cobitolimod or placebo as soon as each three weeks.
Cobitolimod in short
Cobitolimod is a first-in-class Toll-like receptor 9 (TLR9) agonist that may present an anti-inflammatory impact regionally within the giant gut, which can induce mucosal therapeutic and aid of the medical signs in ulcerative colitis. Cobitolimod is being evaluated within the part III examine CONCLUDE as a novel therapy of reasonable to extreme ulcerative colitis. Cobitolimod met the first endpoint within the part IIb examine CONDUCT and demonstrated an excellent mixture of efficacy and security. The outcomes have been revealed within the respected medical journal, The Lancet Gastroenterology & Hepatology. Information from 4 earlier accomplished placebo-controlled medical trials help the efficacy and security demonstrated within the CONDUCT examine.
InDex Prescribed drugs in short
InDex is a pharmaceutical improvement firm specializing in immunological ailments the place there’s a excessive unmet medical want for brand new therapy choices. The corporate’s lead asset is the drug candidate cobitolimod, which is being evaluated within the part III examine CONCLUDE as a novel therapy of reasonable to extreme ulcerative colitis – a debilitating, persistent irritation of the massive gut. InDex has additionally developed a platform of patent protected discovery stage substances, so known as DNA primarily based ImmunoModulatory Sequences (DIMS), with the potential for use within the therapy of varied immunological ailments.
InDex is predicated in Stockholm, Sweden. The corporate’s shares (ticker INDEX) are traded on Nasdaq First North Development Market Stockholm. Redeye AB with e mail handle [email protected] and telephone quantity +46 8 121 576 90 is the corporate’s Licensed Adviser. For extra data, please go to www.indexpharma.com.
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SOURCE Index Prescribed drugs