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news.InDex Pharmaceuticals Holding has developed a novel formulation of its lead drug candidate cobitolimod for oral administration, with targeted delivery to the lower part of the gastrointestinal tract.
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The oral formulation of cobitolimod is a potential follow-on product to the topical formulation, which is currently being investigated in the CONDUCT study – a phase IIb dose optimisation study in moderate to severe active ulcerative colitis.
Topical application of cobitolimod can provide rapid onset of action, while minimizing the risk of systemic side effects, when administered rectally to the site of inflammation in left-sided ulcerative colitis. However, oral therapy could enable delivery of cobitolimod to parts of the gastrointestinal tract which are inaccessible to the topical delivery system.
The developed oral product consists of a core matrix in a capsule with a pH sensitive coating, designed to initiate release of cobitolimod in the terminal ileum for controlled delivery to the colon. This oral formulation development provides opportunities for securing additional intellectual property.
The GMP ready capsule has demonstrated stability with a documented high probability of extended release in the colon. The in vitro release profile is similar to those of marketed oral mesalazine products, with controlled release technologies. Additionally, the release profile can be adjusted to target other parts of the gastrointestinal tract, both by modifying the composition of the core matrix and the coating of the capsule.
InDex Pharmaceuticals CEO Peter Zerhouni said: "We have seen competitive efficacy and an excellent safety profile with the current formulation of cobitolimod. Patient and physician market research supports its future acceptance and commercial potential in both the US and Europe.
"Nevertheless, an oral version would provide added patient convenience and broaden the potential therapeutic use of cobitolimod to extensive colitis and even Crohn's disease, thus significantly increasing the asset's value."
InDex's life cycle management strategy for cobitolimod is to launch first the topical formulation, for which top line results from the CONDUCT study are expected in the fourth quarter of 2018. The oral formulation will be a follow-on product and the next stage of its development is contingent on the results of CONDUCT.
Source: Company Press Release
