Nestlé Health Science recently announced that it has entered into a license partnership with Lipid Therapeutics, a biopharmaceutical company focused on the development and commercialization of phospholipids, for global exclusive rights (except in Australia and Europe) over Lipid Therapeutics’ LT-02 agent (phosphatidylcholine), a novel treatment able to improve the mucosal barrier function in patients with mild-to-moderate ulcerative colitis.
Under the terms of the agreement, Nestlé will conduct the development and commercialization of LT-02 upon approval by authorities in the licensed geographic regions. In 2016, Nestlé expects to begin Phase III clinical studies in the United States. The financial details of the partnership are, however, undisclosed.
The European development partner of Lipid Therapeutics, Dr. Falk Pharma GmbH, a pharmaceutical company dedicated to gastroenterology, revealed the initiation of phase III clinical studies for LT-02 in Europe last October. Under the terms of the development strategy, the three companies will collaborate to acquire clinical evidence supporting LT-02’s health effects as an ulcerative colitis treatment in order to obtain the drug’s approval.
Ulcerative colitis is an inflammatory disease of the colon and the prevalent opinion believes that an inflammation of the upper section of the colon’s mucosal wall is the cause for the disease. Accordingly, current treatment strategies like aminosalycilates (5-ASAs), steroids, immuno-suppressants and biologicals target the inflammatory cascade to prevent further damage to the mucosal cells and to normalize the function of the colon. However, estimates indicate that about 40% of the patients with ulcerative colitis under the recommended dose of 5-aminosalicylic acid still experience persistent disease activity flares.
The Nestlé Health Science clinical development program will firstly investigate LT-02 as an add-on treatment to 5-aminosalicylic acid. The mechanism of action of LT-02 is based on the restoration of the gut mucosa colonic barrier function, through an anti-inflammatory signaling. LT-02 is a first-in-class therapy for patients with the condition that still experience disease flares while under treatment with mesalazine, a 5-ASA drug.
Greg Behar, CEO of Nestlé Health Science, said in a news release, “LT-02 has paradigm changing potential in the management of ulcerative colitis in terms of improving patient outcomes and reducing the need for biologics and corticosteroids. The growing number of patients that suffer from chronic gastrointestinal conditions worldwide increases our determination to make an impact, through innovative, integrated therapeutic approaches. This agreement enables us to further build our gastrointestinal pipeline, a key focus of our Novel Therapeutic Nutrition business area with the aim of developing nutritional therapies coupled with innovative drug and diagnostics solutions.”
Dr. Gerhard Keilhauer, CEO of Lipid Therapeutics, concluded: “Based upon initial trials, we are convinced of the transformational potential of LT-02. With Dr. Falk Pharma and now Nestlé Health Science as licensees in key geographies, the resources and capabilities are at work to translate potential into a breakthrough therapy.”