Lipid Therapeutics Announces Positive Topline Phase IIb Results With LT-02 in Patients With Ulcerative Colitis
Posted on: Wednesday, 22 June 2011, 02:00 CDT
HEIDELBERG, Germany, June 22, 2011 /PRNewswire/ –
– Primary Endpoint Met
Lipid Therapeutics, a biotechnology company focused on novel treatmentsfor inflammatory bowel disease, today announced positive topline resultsfrom a Phase IIb clinical trial with its lead product, LT-02, in patientswith ulcerative colitis. LT-02 is a controlled release formulation ofphosphatidylcholine that has been specifically designed to treat ulcerativecolitis by improving the barrier function of the mucosal layer of the colon,a concept that has now been successfully tested in several clinical trials.
The Phase IIb trial met the primary end point, change in SCCAI (SimpleClinical Colitis Activity Index), for patients refractory to standardfirst-line intervention who were treated with LT-02 at 0.8g four times a day(51% reduction with LT-02 vs 33% reduction with placebo; p <0.05). Patientswho received one of two lower doses of LT-02 also showed a positive benefit.The excellent safety profile of LT-02 treatment was comparable to placebo atall three doses.
The Phase IIb trial was a randomized, multi-center, double-blind,parallel group, placebo-controlled, dose ranging study that was designed toinvestigate the efficacy and safety of LT-02 in patients withmesalazine-refractory ulcerative colitis. 156 patients were enrolled intothe trial at 24 centers in Germany, Lithuania and Romania. Patients wererandomized to receive one of three doses of LT-02 or placebo and weretreated for a period of 12 weeks. Lipid Therapeutics intends to present fulldata on the trial at UEGW in Stockholm in October 2011.
Dr. Gerhard Keilhauer, CEO of Lipid Therapeutics, said: “The resultsthat we have announced today are a key milestone for Lipid Therapeutics. Weare delighted that LT-02, which has a novel mode of action, has been shownto be of significant benefit to patients with ulcerative colitis whosecondition has not responded to the current mainstay of therapy, i.e.mesalazine. We will now discuss with our European partner, Dr. Falk Pharma,and with potential partners in the US and Japan how we can rapidly move thisinnovative therapeutic into a pivotal Phase III study, the next key step inmaking it available to ulcerative colitis patients as quickly as possible.”
Max Karner MD , University Clinic Heidelberg, Germany, who was thePrincipal Investigator for the study, said: “The positive clinical resultsthat we have seen with patients treated with LT-02 clearly suggests that ithas the potential to become a very attractive new treatment option forpatients with ulcerative colitis who currently have limited options. I wouldlike to take this opportunity to thank all of the investigators and patientswho took part in this very important study which was completed ahead ofschedule and has delivered excellent results.”
About Inflammatory Bowel Disease
Ulcerative colitis is a chronic, relapsing inflammatory disorder thataffects the mucosal lining of the rectum and extends proximally to affect avariable extent of the colon. Clinical characteristics include rectalbleeding, diarrhea and abdominal pain. Worldwide more than 1 million peoplesuffer from ulcerative colitis. 5-aminosalicylic acid is the standard ofcare but it often fails to control the disease in the longer term. Acuteflares can be treated with steroids but they are unsuitable for long-termtreatment, while immunosuppressants have a considerable risk profile.Despite these treatment options, up to 40% of patients may require surgicalremoval of their colon.
LT-02 is a novel controlled release formulation of phosphatidylcholinethat augments the natural protective mucosal barrier in the lower gut. It isthe first product candidate worldwide that targets the pathological changesin the lower gut barrier function of colitis patients which are thought tobe one of the main underlying disease causes.
About Lipid Therapeutics
Lipid Therapeutics is a biopharmaceutical company focused on thedevelopment and commercialization of phospholipids and their use for thetreatment of ulcerative colitis. Lipid Therapeutics was founded in 2008,based on groundbreaking scientific work performed by Prof. Wolfgang Stremmelat the Krehl University Clinic in Heidelberg. The company is headquarteredin Heidelberg (Germany) and is financed through the EMBL Technology Fund andCD Ventures. In August 2009, Lipid Therapeutics concluded a co-developmentand option agreement for its lead product LT-02 with market leader Dr. FalkPharma, Freiburg (Germany).
Contact Lipid Therapeutics GmbH: Dr. Gerhard Keilhauer Managing Director Phone: +49-6221-3350581 Fax: +49-6221-3350589 Email: keilhauer@lipid-therapeutics.com [keilhauer@lipid-therpeutics.com ] http://www.lipid-therapeutics.com Citigate Dewe Rogerson: Sita Shah / Chris Gardner Phone: +44(0)-20-7282-1052 Email: sita.shah@citigatedr.co.uk/chris.gardner@citigatedr.co.uk
SOURCE Lipid Therapeutics
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Tags: barrier function, Chris Gardner, controlled release formulation, FDA Phase, main underlying disease, Primary Endpoint Met Lipid Therapeutics, Falk Pharma
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