Tag: Jesper Wiklund

Company News: InDex Pharmaceuticals and Almirall enter into a license agreement for European rights of the phase III drug candidate Kappaproct®

InDex Pharmaceuticals and Almirall announced today that they have signed a license agreement for the European marketing rights to the drug candidate Kappaproct®.  Under the terms of the agreement, InDex is eligible for an upfront payment as well as success driven milestone payments with a total deal value that could exceed EUR100M. InDex is also entitled to receive double digit royalties from Almirall on the European net sales of Kappaproct®.

InDex Pharmaceutical’s lead drug candidate Kappaproct® is a DNA-based immunomodulatory sequence (DIMS) that targets the toll-like receptor 9 (TLR9). Kappaproct is a potential treatment for severe Ulcerative Colitis (UC), a debilitating, chronic inflammation of the large intestine. The results from the ongoing Phase III trial COLLECT are expected in mid-2014.

 

Company News: InDex Pharmaceuticals Closes $20 m Financing Round, Welcomes NeoMed as New Shareholder

InDex Pharmaceuticals today announced the successful closing of a USD 20 million / EUR 15 million new rights issue. NeoMed led the oversubscribed financing round while current shareholders participated with 75% of the invested capital.

In summer 2014, InDex Pharmaceuticals expects to report data from a Phase III study with its lead product candidate Kappaproct®, which is being developed for the treatment of severe Ulcerative Colitis (UC) – a debilitating, chronic inflammation of the large intestine.

In conjunction with the investment, Dr. Erik Amble, Managing Partner and founder of NeoMed Management, has been appointed as a new member of the company’s Board of Directors. Dr. Amble has over 25 years of experience with venture capital investments in Europe and the U.S.

Since 2012, Kappaproct® has been investigated in the COLLECT trial, a European multicenter Phase III study to evaluate the effectiveness and safety for the treatment of chronic active, refractive ulcerative colitis (UC) patients. Kappaproct® is a DNA-based immunomodulatory sequence (DIMS) targeting the toll-like receptor 9 (TLR9). Primary endpoint of the COLLECT study is induction of clinical remission in severe UC patients, who have failed all other medical treatments and whose only remaining treatment option is colectomy.

Company News: InDex Pharmaceuticals Reports Completion of Patient Recruitment in Phase III Ulcerative Colitis Study (COLLECT) with Kappaproct®

InDex Pharmaceuticals today announced the completion of patient enrollment for its Phase III COLLECT study of Kappaproct. The multinational, randomized, double-blind, placebo-controlled study reached the recruitment goal of 120 patients with treatment-refractory Ulcerative Colitis (UC). InDex is expecting final study results in mid-2014.

The Phase III trial is designed to assess Kappaproct’s efficacy and safety in treatment-refractory UC patients. This cohort consists of chronic active UC patients who have failed all currently available pharmaceutical treatment and whose only remaining treatment option is surgical removal of the colon. This is a rare group of patients with a very high unmet medical need. Kappaproct has an Orphan Drug Designation in Europe.

The study is conducted in seven European countries. The primary endpoint of the study is the induction of clinical remission at week 12. Secondary endpoints, among others, are the rate of and time to colectomy. The patients will be followed for a total of 52 weeks.

Kappaproct is a DNA-based immunomodulatory sequence (DIMS) targeting the toll-like receptor 9 (TLR9). Kappaproct has shown positive effects on key symptoms of UC such as stool frequency, blood in stool and mucosal healing in a previous phase II proof-of-concept study. Kappaproct has also demonstrated a favorable safety and side effect profile in previous clinical trials.

Company News: InDex Pharmaceuticals Granted Japanese Patent for Novel Treatment of Steroid-Resistant Inflammation

InDex Pharmaceuticals today announced that it has been granted a Japanese patent by the Japan Patent Office (JPO). The patent provides protection for the use of Kappaproct® and other DNA-based immunomodulatory sequences (DIMS) for the treatment of steroid-resistant inflammatory diseases, including inflammatory bowel disease, rheumatoid arthritis, psoriasis, asthma, emphysema, and chronic obstructive pulmonary disease.

The patent, entitled “Immunostimulatory Method” covers the use of a broad range of oligonucleotides for the treatment of steroid resistance in patients afflicted with inflammatory conditions. It provides an exclusivity period until at least 2026, with the possibility of up to 5 years of patent term extension after market approval. InDex Pharmaceuticals already holds patent protection for Kappaproct for the treatment of steroid-resistant inflammatory diseases in both Europe and the US.

InDex Pharmaceuticals develops DIMS compounds – synthetic oligonucleotides that function as immunomodulatory agents by targeting the Toll-like receptor 9 (TLR9). The company’s most advanced DIMS product candidate, Kappaproct, is currently in a phase III study in Europe for the treatment of chronic, active, treatment-refractory ulcerative colitis.

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