Ionis Brings Treatment for Gastrointestinal Immune Disorders to Clinical-trial Stage

Ionis Brings Treatment for Gastrointestinal Immune Disorders to Clinical-trial Stage

Janssen Biotech plans a Phase 1 clinical trial of a therapy that its partner Ionis Pharmaceuticals developed as a treatment for gastrointestinal immune disorders.

Under their collaboration agreement, Ionis received $5 million for bringing the therapy, IONIS-JBI 1-2.5 Rx, to the clinical-trial stage.

Janssen is responsible for obtaining regulatory approval of the treatment worldwide, and commercializing it.

Ionis stands to gain up to $585 million more in milestone payments and license fees. It will also receive a percentage of the sales of any product that reaches the market.

Ionis specializes in RNA-focused therapies for patients with unmet medical needs, including those with gastrointestinal immune disorders and inflammatory bowel diseases.

Ionis used its proprietary antisense technology to develop IONIS-JBI 1-2.5 Rx.

An antisense therapy consists of snythetic RNA that binds to the messenger RNA a faulty gene produces. The binding inactivates the messenger RNA, turning the gene off. This silencing prevents the gene from producing the abnormal protein associated with a disease.

IONIS-JBI 1-2.5 Rx is the first oral antisense therapy for gastrointestinal immune disorders that Ionis has brought to the clinical-trial stage.

“We are pleased with the success of our collaboration with Janssen,” C. Frank Bennett, Ionis’ senior vice president of research, said in a press release. “In under two years, we have advanced a drug into clinical trials” and begun studying “a second drug development candidate, IONIS-JBI 1-2.5 Rx.”

“Our collaboration with Janssen combines Ionis’ broad applicability of our antisense technology with their expertise in GI [gastrointestinal] autoimmune disorders and therapeutic formulation,” Bennett added. An autoimmune disorder is one that involves the immune system attacking healthy tissue instead of invaders.

In June of 2017, Janssen announced a partnership with Protagonist Therapeutics to develop, manufacture and market a new treatment for the bowel diseases Crohn’s and ulcerative colitis.

The therapy candidate, PTG-200, is an IL-23 receptor antagonist. When the receptor and IL-23 protein bind, the interaction generates cell signals that promote the inflammation seen in bowel diseases. PTG-200 prevents the binding, short-circuiting the inflammation.

The U.S. Food and Drug Administration has accepted Protagonist’s Investigational New Drug application for PGG-200, paving the way for the therapy to enter clinical trials.

Protagonist delivered a presentation at the Digestive Disease Week conference in Chicago in May of 2017 showing that PTG-200 alleviated mice’s bowel disease.

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