Janssen and Protagonist to Develop, Market PTG-200 for the Treatment of IBD

Janssen and Protagonist to Develop, Market PTG-200 for the Treatment of IBD

Janssen Biotech and Protagonist Therapeutics are partnering to develop, manufacture, and market PTG-200 as a treatment for Crohn’s disease and ulcerative colitis (UC).

PTG-200 is a potential first-in-class oral IL-23R antagonist under development for moderate to severe Crohn’s disease, a form of inflammatory bowel disease (IBD).

The drug has received investigational new drug (IND) status by the U.S. Food and Drug Administration, allowing Protagonist to begin clinical studies. A Phase 1 clinical trial evaluating the drug is expected to begin this year.

Under the agreement, Janssen will pay Protagonist an upfront amount of money. Protagonist may also be eligible to receive additional development and commercialization milestone payments. If PTG-200 is approved and commercialized, Protagonist can also receive royalties on net sales and will also have the option to co-detail in the U.S. The transaction is expected to close in the coming months.

In May, Protagonist presented preclinical results from PTG-200 as a potential treatment for Crohn’s disease at the Digestive Disease Week conference in Chicago. During the presentation, researchers showed that by inhibiting the interleukin-23 pathway with PTG-200, disease outcomes were improved in a mouse model of IBD.

“The addition of PTG-200 to the Janssen Immunology portfolio builds upon our expertise and leadership in the IL-23 pathway and we look forward to advancing this novel oral IL-23R antagonist into clinical development,” Susan B. Dillon, PhD, Janssen’s global therapeutic area head, immunology, said in a press release.

“Together with Johnson & Johnson Innovation, we have forged a strong relationship with the Protagonist Therapeutics team over the course of several years.  We look forward to continuing a strong and productive collaboration in progressing this novel oral candidate for the treatment of inflammatory bowel disease,” she added.

Scott E. Plevy, MD, vice president and area leader of inflammatory bowel disease at Janssen, said the biotech will continue studies into IBD and “advance novel therapeutics like PTG-200, an oral therapy that targets a validated pathway and acts locally in the gut at the site of disease.”

“We’re particularly excited to add an oral peptide-based therapy to our robust portfolio as we aim to address the increasing incidence of inflammatory bowel disease and the growing needs of people living with Crohn’s disease and ulcerative colitis around the world,” he said.