FDBusiness.com

Nestlé Health Science has entered into a license agreement with Lipid Therapeutics for exclusive rights worldwide, except for Europe and Australia, to Lipid Therapeutics’ LT-02 compound (phosphatidylcholine), a novel barrier function therapy for patients with mild-to-moderate ulcerative colitis. Under this agreement, Nestlé Health Science will further develop and commercialize LT-02 upon marketing approval by the relevant authorities in the licensed geographies. Nestlé Health Science plans to start phase III clinical trials in the US in 2016. The financial terms of the licensing partnership are not being disclosed.

Lipid Therapeutics’ European development partner, Dr Falk Pharma GmbH, a pharmaceutical company specialized in gastroenterology, announced the start of phase III trials for LT-02 in Europe in October 2014. As part of a strategic development approach, Nestlé Health Science, Dr Falk and Lipid Therapeutics will collaborate to generate the required clinical evidence in support of LT-02’s beneficial effects in the treatment of ulcerative colitis in order to obtain drug regulatory approvals.

More than one million people worldwide are estimated to suffer from ulcerative colitis, a chronic and debilitating inflammatory condition of the large intestine. The most common treatment is 5-aminosalicylic acid (mesalazine), However it is estimated that 40% of patients receiving the recommended dose of 5-aminosalicylic acid continue to experience persistent disease activity flares. The NHSc development program will primarily assess LT-02 as an add-on therapy to 5-aminosalicylic acid. LT-02 has a novel mode of action that restores the colonic barrier function in the gut mucosa or ‘wall’ and through anti-inflammatory signalling and represents a first-in-class therapy for those patients still suffering flares while being treated with mesalazine.

Greg Behar CEO of Nestlé Health Science, says: “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, says: “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.”

This licensing agreement is part of Nestlé Health Science’s strategy to develop its product portfolio for gastrointestinal diseases, a key focus of its Novel Therapeutic Nutrition business area.