On August 27, we had the great pleasure of reporting successful top line results in the phase IIb study CONDUCT with cobitolimod.
STOCKHOLM, Nov. 27, 2019 /PRNewswire/ -- “Something that really differentiates cobitolimod from its competitors is the superior safety profile. Both the approved drugs and those currently being tested in phase III are associated with serious side effects. With an outstanding combination of efficacy and safety, cobitolimod is set to take a leading position within the field,” said Peter Zerhouni, CEO of InDex Pharmaceuticals. Period July - September 2019
Period January - September 2019
All comparative amounts in brackets refer to the outcome during the corresponding period 2018. Significant events during July - September 2019
Significant events after the reporting period
CEO statement The CONDUCT study was an exploratory study to find the best dose to move forward in development, and the study clearly showed that the highest dose was the most effective. As in previous studies, cobitolimod was well tolerated at all dose levels and no differences in the safety profile were observed compared to placebo. The study thus met the objectives that we set up before the start of the study. The efficacy was within the expected range and is comparable to what has been reported for the drugs that are currently on the market for moderate to severe ulcerative colitis and the new substances that are in phase III right now. Something that really differentiates cobitolimod from its competitors is the superior safety profile. Both the approved drugs and those currently being tested in phase III are associated with serious side effects. With an outstanding combination of efficacy and safety, cobitolimod is set to take a leading position within the field. An additional advantage of cobitolimod that stands out compared to the competitors is the new and unique mechanism of action. Many patients with moderate to severe ulcerative colitis do not respond to current therapies, and there is more and more talk about combining several drugs to optimise the efficacy for the patients. With its unique mechanism of action and safety profile, cobitolimod is better suited than competing products for such an approach. DIRECTED SHARE ISSUE TAKES COBITOLIMOD TO PHASE III The proceeds of the share issue are primarily intended to prepare cobitolimod for phase III, which is the final stage of development before applying for market approval. We had already before the CONDUCT results planned a long list of phase III preparatory activities that we launched as soon as we saw the positive outcome of the study. We are now analysing the full data set with the intention of publishing complete study results in a scientific journal and presenting them at upcoming medical conferences. We have initiated contacts with the European and American regulatory authorities, EMA and the FDA, to discuss phase III design. We are planning market research with physicians and payers. We have started the process of choosing a contract research organisation (CRO). We have ordered study drug and have started the preclinical safety studies required for phase III. With the current timeline, we should have enough information to finalise the design of the phase III program in the second quarter of 2020 and be ready to enrol the first patient in the second half of 2020. NEW FINANCIALLY STRONG INVESTORS STRENGTHEN THE SHAREHOLDER BASE NEW POSSIBILITIES FOR PHASE III DESIGN CREATES STRATEGIC FLEXIBILITY From a strategic and negotiation perspective, it is a great strength to be autonomous and be able to control the timing and circumstances for potential future partnerships. As we prepare for phase III on our own, we continue our business development work to present the positive CONDUCT results and development plans to companies that have shown interest in cobitolimod. The possibility of a less extensive phase III program also widens the universe of potential partners to include regional and speciality pharma companies. Also the large global companies can appreciate the benefits of an innovative phase III program. Even if they do not have capital constraints, there is competition for patients and smaller studies means a faster way to market. With positive phase IIb results, new capital, a strong shareholder base and strategic flexibility, we look forward to 2020 and the further development of cobitolimod and InDex as a company. For more information: The full report is attached as a PDF and is available on the company’s website https://www.indexpharma.com/en/category/interim-reports/ Publication InDex Pharmaceuticals in brief InDex is based in Stockholm, Sweden. The company’s shares (ticker INDEX) are traded on Nasdaq First North Growth Market Stockholm. Redeye AB with email address certifiedadviser@redeye.se och phone number +46 8 121 576 90 is the company’s Certified Adviser. For more information, please visit www.indexpharma.com. This information was brought to you by Cision http://news.cision.com The following files are available for download:
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Company Codes: ISIN:SE0008966295, Stockholm:INDEX |