InDex Pharmaceuticals prepares the commercialization of cobitolimod

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STOCKHOLM, March 14, 2022 /PRNewswire/ — InDex Pharmaceuticals Holding AB (publ) plans self-commercialization of drug candidate cobitolimod in the United States with strategic collaborations in other regions. The launch is planned for 2027, with an annual sales potential of more than $1 billion, in moderate to severe left ulcerative colitis. An in-depth presentation of the strategy and market potential, as well as execution of the CONCLUDE Phase III study with cobitolimod will be provided at InDex’s Capital Markets Day tomorrow. March 1415:00-17:00 CET.

Approximately 400,000 patients suffer from moderate to severe left-sided ulcerative colitis despite treatment with conventional therapies. Cobitolimod is the only advanced drug candidate specifically focused on this patient population. Cobitolimod has shown competitive efficacy against currently available treatment options, but unlike these therapies, it has no known side effects.

“Provided CONCLUDE confirms the results of previous positive clinical trials with cobitolimod, patients may have access to a treatment that is as effective or even better than today’s advanced therapies, but without the side effects serious that these can cause. Additionally, cobitolimod is easy to self-administer and has an infrequent dosing schedule, unlike current market leaders, which require in-clinic or at-home injections. With the Phase III program underway, we are beginning to prepare for the commercialization of cobitolimod,” says Pierre ZerhouniCEO of Index Pharmaceuticals.

Market potential
The total ulcerative colitis market has over the past four years reported an average CAGR of 10% and accounted for approximately $7.5 billion in 20201. The market is expected to grow with a CAGR of around 6% and reach $11-12 billion by 20261. InDex estimates that the moderate to severe left ulcerative colitis market segment will account for more than $5 billionwhen cobitolimod was launched.

The target product profile of cobitolimod has been evaluated in several primary market studies, demonstrating that cobitolimod has strong potential to position itself as the first treatment option for patients with moderate to severe, unresponsive left ulcerative colitis. to conventional treatments. InDex estimates that cobitolimod can reach a market share of 20-30%, corresponding to a global peak in annual sales of more than $1 billion.

Marketing strategy
InDex has, with external experts, analyzed the commercialization options for cobitolimod in the United States and Europe. The United States accounts for approximately 65% ​​of the total ulcerative colitis market1. The conclusion is that the market potential, required business footprint, and profitability profile in the United States are respectively well suited for self-marketing by a targeted business organization to be built closer to launch.

The fragmented European market, as well as other regions, offers exciting opportunities to enter into strategic collaborations as cobitolimod moves towards launch.

Launch schedule
The results of the first ongoing phase III study with cobitolimod should be available in the second half of 2023. An interim analysis to select the best dose is planned when approximately 30% of participants have completed the study. The full Phase III program, including a second induction study and a one-year maintenance study, is expected to be completed during 2026. Marketing authorization applications will then be submitted to regulatory authorities, with a launch of cobitolimod in 2027. the main milestones are summarized below:

  • The results of the first phase III study are expected in H2 2023
  • Phase III program expected to be completed in 2026
  • Marketing authorization and launch are expected in 2027

Expanding the potential of cobitolimod
Current development is focused on the rectal formulation of cobitolimod for moderate to severe left-sided ulcerative colitis. InDex also sees significant potential for cobitolimod in related indications. For this reason, the development of an oral formulation, as a potential follow-up product, is continuing in parallel. An oral formulation that allows administration of cobitolimod to other parts of the gastrointestinal tract would open the possibility of expanding the therapeutic use of cobitolimod and thereby increasing the market potential many-fold.

Capital Markets Day on March 14, 2022
At Index’s Capital Markets Day tomorrow March 1415:00-17:00 CET, CEO Pierre Zerhouni in collaboration with external U.S. commercialization experts and members of the InDex development team for cobitolimod, will provide an in-depth overview of cobitolimod’s strategy, market potential, and execution of the phase III CONCLUDE study. Capital Markets Day will be held at Krügersalen at Kapitel 8, Tändstickspalatset, Västra Trädgårdsgatan 15 at stockholm. Presentations will start at 3:00 p.m. CET with registration starting at 2:30 p.m. CET. Capital Markets Day will be held in English and will be streamed live at https://tv.streamfabriken.com/index-pharmaceuticals-cmd-2022. A recording will be available later on the Index website.

1Rami Al-Horani et al Nat Rev Drug Discov. Jan 2022;21(1):15-16

For more information:
Pierre ZerhouniCEO
Telephone: +46 8 122 038 50
E-mail: [email protected]

Publication
This information is information that InDex Pharmaceuticals Holding AB (publ) is required to make public in accordance with the European Market Abuse Regulation (MAR). The information has been submitted for publication through the contact person listed above at 9:25 p.m. CET to March 13, 2022.

Cobitolimod in a nutshell
Cobitolimod is a first-in-class Toll-like receptor 9 (TLR9) agonist that can provide an anti-inflammatory effect locally in the large intestine, which can induce mucosal healing and relief of clinical symptoms of ulcerative colitis. Cobitolimod is being evaluated in the phase III CONCLUDE study as a new treatment for moderate to severe ulcerative colitis. Cobitolimod met the primary endpoint of the Phase IIb CONDUCT study and demonstrated an exceptional combination of efficacy and safety. The findings were recently published in the reputable medical journal The Lancet Gastroenterology & Hepatology. Data from four prior placebo-controlled clinical trials support the efficacy and safety demonstrated in the CONDUCT study.

About InDex Pharmaceuticals
InDex is a pharmaceutical development company specializing in immunological diseases for which there is a significant 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 CONCLUDE study as a novel treatment for 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 called DNA-based immunomodulatory sequences (DIMS) that can be used in the treatment of various immunological diseases.

InDex is based on Stockholm, Sweden. The company’s shares (INDEX ticker) are traded on the Nasdaq First North Growth Market Stockholm. Redeye AB with email address [email protected] and telephone number +46 8 121 576 90 is the company’s certified advisor. For more information, please visit www.indexpharma.com.

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SOURCE Index Pharmaceuticals

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