-=Protagonist Therapeutics (PTGX) : colitis treatment trial deemed 'futile'

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Protagonist Therapeutics to discontinue Phase 2b PROPEL study of PTG-100 following interim analysis by Independent Data Monitoring Committee 

This decision followed a planned interim analysis by an independent Data Monitoring Committee (DMC) of unblinded efficacy and safety data from the first 65 patients from the ongoing 240 patient trial who had completed the 12 week treatment with PTG-100. Using pre-specified criteria, the DMC deemed the trial to be futile based on an analysis of the primary endpoint of clinical remission. No safety concerns were noted in the analysis.

• Based on the DMC's recommendation received after the market close on Friday, and while further review of the data is being conducted, Protagonist is notifying PROPEL trial investigators that randomization of potential participants and further treatment of patients currently in the study will be discontinued. Additionally, the Company will postpone its decision about the initiation of a Phase 2/3 clinical trial of PTG-100 in chronic pouchitis until after its full review of the interim data from the UC PROPEL study.

FDA OKs Abbott's Humira for colitis

U.S. health regulators on Friday approved Abbott Laboratories Inc's blockbuster rheumatoid arthritis drug Humira for the treatment of moderate to severe ulcerative colitis, a form of inflammatory bowel disease.

The U.S. Food and Drug Administration approved Humira for use by adults to help control the chronic condition once immunosuppressant medicines, such as corticosteroids, have proved ineffective.

Humira, by far Abbott's biggest product with annual sales of about $8 billion and still growing, is already approved to treat a number of inflammatory diseases. In addition to rheumatoid arthritis, the medicine is approved for psoriatic arthritis, ankylosing spondylitis, Crohn's disease, plaque psoriasis and juvenile idiopathic arthritis.

Morningstar analyst Damien Conover said the latest approval "will help to continue building the franchise" and could eventually add annual revenue approaching $500 million.

Ulcerative colitis, a chronic disease that causes inflammation and ulcers in the inner lining of the large intestine, affects about 620,000 Americans, according to the National Institutes of Health.

"Each patient with ulcerative colitis experiences the disease differently, and treatment must be adjusted to meet each individual's needs," Donna Griebel, of the FDA's Division of Gastroenterology and Inborn Errors Products, said in a statement.

"Today's approval provides an important new treatment option for patients who have had an inadequate response to conventional therapy," she added.

Humira should only continue to be used in patients who have shown evidence of clinical remission after eight weeks of therapy, the FDA said.