Company News: InDex Pharmaceuticals Appoints Uli Hacksell and Jesper Wiklund to its Board of Directors
InDex Pharmaceuticals today announced that Uli Hacksell and Jesper Wiklund have been appointed as new members of the Board of Directors. Professor Hacksell and Mr Wiklund together bring to InDex over 40 years of senior management experience from the life sciences industry in drug development, commercial operations, and business development.
Uli Hacksell has over 20 years of international management experience from both large pharmaceutical and biotech companies. He was the CEO of ACADIA Pharmaceuticals from September 2000 to March 2015, and led the company from a private start-up to becoming a public multibillion dollar company listed on the NASDAQ. Previously, Prof. Hacksell held senior executive positions at Astra AB and was president of Astra Draco, one of Astra’s largest Research and Development subsidiaries, where he directed an organization of more than 1,100 employees. Earlier in his career he held the position of Professor in Organic Chemistry at Uppsala University. He has a diverse Board experience from several long-term assignments, including SynAct Pharma A/S, SLS Invest AB, Action Pharma A/S and the Swedish Medical Products Agency. He currently serves on the Board of Directors of Uppsala University.
Jesper Wiklund has over 20 years of international commercial experience in the biotechnology and pharmaceutical industry. Mr Wiklund currently holds the position of Managing Director at Oberland Capital. Mr Wiklund was CEO of InDex Pharmaceuticals from September 2011 to March 2015. Over the course of his career he has completed strategic transactions with an aggregate value exceeding USD 700 million. He previously worked at Swedish Orphan Biovitrum where he was responsible for Business Development, at Wyeth Pharmaceuticals and Elan Pharmaceuticals in the United States and at Evotec in Germany. Mr Wiklund has a B.Sc. from St Marys College of California and a MBA from Harvard Business School.
InDex Pharmaceuticals today announced the termination of a license agreement with Almirall S.A. relating to the drug candidate Kappaproct® for the treatment of ulcerative colitis. Under the agreement, which was signed in March 2014, Almirall licensed exclusive rights to Kappaproct® for the European market. Upon termination of the agreement, InDex regains all worldwide development and commercialization rights for Kappaproct®, which is in late-stage clinical development.
The termination of the agreement follows Almirall’s recent repositioning of their R&D organization to leverage strong formulation capabilities and high-quality New Chemical Entities (NCEs) in Dermatology. Almirall has communicated that their new strategy is to become a leading specialty pharmaceutical company with a strong focus on improving the lives of Dermatology patients and that the company will use its strong cash position to fund growth opportunities in this direction.
Kappaproct® is InDex Pharmaceutical’s lead drug candidate and is in late-stage clinical development for moderate to severe ulcerative colitis, a debilitating, chronic inflammation of the large intestine. Kappaproct® is a DNA-based immunomodulatory sequence (DIMS) that targets the toll-like receptor 9 (TLR9). The recent COLLECT study was conducted in seven European countries and included 131 patients with moderate to severe ulcerative colitis with inadequate response to conventional therapy. They received either Kappaproct® or placebo in addition to conventional treatment. Kappaproct® demonstrated statistically significant effects on endpoints that are highly relevant both from a regulatory and clinical perspective such as key clinical symptoms, i.e. blood in stool and number of stools, and mucosal healing. The primary endpoint of clinical remission at 12 weeks using the CAI score was not met due to an unexpectedly high placebo rate for this endpoint. The next clinical study with Kappaproct® is currently being planned in discussion with EU and US regulatory agencies.
Company News: InDex Pharmaceuticals to present results from the COLLECT trial at the 10th Congress of the European Crohn’s and Colitis Organisation
InDex Pharmaceuticals today announced that results from COLLECT, a clinical study of the toll-like receptor 9 (TLR9) agonist Kappaproct as an add-on therapy for patients with moderate to severe, chronic active Ulcerative Colitis, will be subject to an oral presentation at the 10th Congress of the European Crohn’s and Colitis Organisation (ECCO). The congress is to be held in Barcelona, Spain on February 18-21, 2015.
In the COLLECT study, 131 patients with moderate to severe Ulcerative Colitis and inadequate response to conventional therapy received either Kappaproct or placebo as an add-on to conventional treatment. The study was conducted at 40 sites in seven European countries.
Despite not meeting the primary endpoint of inducing clinical remission measured at week 12, defined by a clinical activity index (CAI) score of ≤4, Kappaproct showed statistically significant improvement on important secondary endpoints at week 4 and 8, including symptomatic remission (blood in stool, number of stools) and registration remission (clinical remission with concurrent endoscopic remission) as well as rate of colectomy at week 22. Kappaproct was well tolerated and no safety signals compared to the standard of care treatment group were evident. The data strongly support continued development of Kappaproct as a promising and well-tolerated novel therapeutic option for refractory ulcerative colitis patients. The next phase III study is planned to start this year.
The presentation (Oral presentation #15) titled “Multicentre clinical trial with topical administration of the Toll-Like receptor 9 agonist DIMS0150 shows evidence for efficacy in moderate to severe Ulcerative Colitis” will be held by Professor Raja Atreya from the University of Erlangen-Nürnberg on Friday, February 20th, 2015, at 14.20pm CET.
Company News: InDex Pharmaceuticals announces results from COLLECT, a clinical trial of Kappaproct® in the treatment of moderate to severe Ulcerative Colitis
InDex Pharmaceuticals today reported top-line results from the double blind, placebo-controlled clinical study COLLECT. The aim of the COLLECT study was to investigate the therapeutic potential of the Toll-like receptor 9 agonist Kappaproct as an add-on therapy for patients with moderate to severe, chronic active Ulcerative Colitis.
Patients treated with Kappaproct showed statistically significant improvement on symptomatic remission (blood in stool, number of stools), registration remission (clinical remission with concurrent endoscopic remission) and the rate of colectomy. The rate of clinical remission (Rachmilewitz Index) was high in both the Kappaproct and the control group and no statistically significant difference was observed on this measure. Kappaproct was well tolerated and no safety signals compared to the standard of care treatment group were evident.
In the COLLECT study, 131 patients with moderate to severe Ulcerative Colitis with inadequate response to conventional therapy received either Kappaproct or placebo as an add-on to conventional treatment. Concominant use of TNF-α inhibitors was excluded. The study was conducted at 40 sites in seven European countries.
Kappaproct was administrated as two single rectal doses, given at week 0 and week 4. The primary endpoint was clinical remission (Rachmilewitz/CAI score of ≤4) measured at week 12. There was an unexpectedly high remission rate in the control group and there was no statistically significant difference observed on this measure. Statistically significant effects were demonstrated on the secondary endpoints symptomatic remission (blood in stool = none, number of stools weekly <35) at week 4 and 8, on registration remission (Rachmilewitz/CAI score of ≤4, plus an endoscopic Mayo score of 0 or 1) at week 4 as well as on the rate of colectomy at week 22. The patients were followed for one year from the first dose to evaluate long-term efficacy and safety. More information about the study can be found on clinicaltrials.gov.