Nestlé Replaces Failed Ulcerative Colitis Program
This article was originally published in Scrip
Nestlé's pharmaceutical arm, Nestlé Health Science, has licensed an ulcerative colitis treatment candidate from Lipid Therapeutics. It plans to start a Phase III trial with it in the US in 2016.
The deal is for rights to LT-02 (phosphatidylcholine) outside Europe and Australia. Lipid's European development partner, Dr. Falk Pharma GmbH, started a European Phase III program for the product in October 2014. Nestlé, Dr. Falk and Lipid will collaborate to generate the clinical data required to obtain drug regulatory approvals in their various territories. Financial details of the transaction have not been disclosed.
Lipid's CEO Dr Gerhard Keilhauer admits finding a US partner "took some time", but Nestlé was worth the wait. "While Nestlé isn't a well-known pharmaceutical company, the Health Science unit is a great fit for LT-02," he claims.
Nestlé created its Health Science business in early 2011 and has made a series of acquisitions towards developing science-based nutritional solutions for medical conditions. Its first such acquisition was that of CM&D Pharma Ltd which was developing products for patients with kidney disease, inflammatory bowel disease and colon cancer.
Nestlé was in fact partnered with Hutchinson MediPharma on an oral drug for ulcerative colitis which was in Phase III trials, but the program was terminated in August last year following an interim analysis.
"So Nestlé has people that are very knowledgeable about this indication and it was interested in looking for another candidate. Phosphatidylcholine actually has natural origins – it comes from soya beans," said Keilhauer.
While searching for a US partner, Lipid used the time to have discussions with the FDA and secure agreements on how a combined European/US development program would proceed. "So overall we didn't really lose much time," believes Keilhauer.
LT-02 has a novel mode of action that restores the colonic barrier function in the gut mucosa. It is being positioned as a treatment for patients with mild-to-moderate ulcerative colitis as an add-on to standard treatment with 5-aminosalicylic acid. Keilhauer said that around 40% of patients receiving the recommended dose of 5-aminosalicylic acid continue to experience persistent disease activity and adding LT-02 to their treatment regimen could prevent these patients having to progress to more aggressive and expensive treatment options.
Greg Behar, CEO of Nestlé Health Science, said, "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."