Lipid Therapeutics has entered into a licensing agreement with Nestle Health Science for exclusive rights to Lipid Therapeutics' LT-02 compound (phosphatidylcholine), a novel barrier function therapy for patients with mild-to-moderate ulcerative colitis (UC), worldwide excluding Europe and Australia. The terms of the license include an upfront fee, milestones payments and royalties on net sales.
Under the agreement Nestle Health Science is responsible for the continued development and commercialization of LT- 02 in its territories, with Phase III clinical trials in the US planned to start in 2016. These trials will primarily assess LT-02 as an add-on therapy in patients with UC not adequately responding to standard doses of 5- aminosalicylic acid, the current standard treatment for the condition.
In October 2014, Lipid Therapeutics' European co- development partner, Dr. Falk Pharma GmbH, a pharmaceutical company specialized in gastroenterology, announced the start of a pivotal Phase III trial with the same compound in Europe. The European and US Phase III trials form part of a global Phase III development program that aims to provide clinical evidence to support regulatory approval of LT-02.
More than one million people worldwide are estimated to suffer from UC, a chronic and debilitating inflammatory condition of the large intestine. It is estimated that 40% of patients receiving the recommended dose of 5- aminosalicylic acid continue to experience flares of disease activity. There therefore exists a significant need for safe and more efficacious UC treatments. LT-02 is a proprietary delayed release formulation of phosphatidylcholine designed as an add-on therapy to 5- aminosalicylic acid to improve the barrier function of the mucosal layer of the colon.
About Ulcerative Colitis
Ulcerative colitis is a chronic, relapsing inflammatory disorder that affects the mucosal lining of the large intestine. Clinical characteristics include rectal bleeding, diarrhea and abdominal pain. Worldwide more than 1 million people suffer from ulcerative colitis.
LT-02 is a first-in-class highly purified phosphatidylcholine targeted to...