InDex Pharmaceuticals recently announced conclusions from its CONDUCT study, evaluating their TLR9 agonist cobitolimod for the treatment of moderate to severe ulcerative colitis.
Congratulations to the positive results from the CONDUCT study. What are the next steps and when can we expect additional results?
“Thank you! Thanks to the strong and unambiguous results from the phase IIb study we are now proceeding with our strategy to bring cobitolimod to phase III. The next step in our preparation is to finalize our ongoing discussions with the European and the US medicines agencies about our proposed setup of the phase III program. We expect to have sufficient decision basis for determining the phase III setup during the second quarter this year. Then we will also be able to define the time frame.”
Read more/Update: InDex Pharmaceuticals has received positive response from FDA and EMA
What opportunities do you have on the market for the treatment of ulcerative colitis?
“We have been focusing on patients with modest to severe ulcerative colitis, a patient group which is hard to treat since many do not respond to or experience adverse effects from today’s pharmaceuticals. Although the biological pharmaceuticals used today have drawbacks and limitations,sales amount to more than 5 billion USD every year for this patient group. The medical need is therefore extensive and comprises people of all ages. Our candidate cobitolimod has shown a superior combination of competitive effect and a remarkable safety profile. Together with a new and unique mechanism of action we estimate that cobitolimod has a great potential as a future treatment option for this affected patient group.”
Describe your business strategy and your preparations for a possible market launch of cobitolimod?
“In order for the commercialization of cobitolimod to be as successful as possible we are working on several parallel tracks. We are consulting the paying authorities and insurance companies, broadening our network with leading opinion formers, carrying out market surveys, establishing a dialogue with patient organizations and many other things. It is too soon to say who will eventually commercialize the product and we are not excluding any options. Therefore we are continuing our business development work by presenting the positive CONDUCT results and our development plans to potential partners who have shown an interest for cobitolimod within the therapy areas of gastroenterology and inflammation. These activities will intensify now when we have the conclusions from the CONDUCT study and soon also feedback from regulatory authorities so that we can convey a complete picture of the continued development towards commercialization of cobitolimod.”
Tell me about your DIMS platform?
“InDex has in addition to cobitolimod a broad pre-clinical portfolio of DNA based Immune Modulating Sequences (DIMS). The DIMS candidates, including cobitolimod, are synthetically produced oligonucleotides that bind to TLR9. TLR9 is the immune system’s receptor for recognizing DNA from bacteria and virus. DIMS inhibits microbial DNA without being harmful to the patient and stimulates immune cells to produce favorable anti-inflammatory compounds that contribute to suppressing inflammation. This opens up great possibilities for treating different inflammatory conditions, where the immune defense is unbalanced.”
Photo of Peter Zerhouni: Kristian Pohl
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