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RedHill Biopharma inflammatory drug meets goals of late-stage study

RedHill Biopharma Ltd. said the phase 3 study of its drug RHB-104 in an inflammatory bowel disease met its main and secondary goals.

Results from the study showed that RHB-104 was better than placebo in achieving remission, or reducing the symptoms, in people with Crohn's disease. At week 26, patients in the RHB-104 group achieved 37% remission, compared with 23% remission in the placebo group.

Statistically significant results also showed that patients who received RHB-104 had a greater response to the experimental treatment at week 26 compared with people in the placebo arm. Patients in the RHB-104 group, when compared with those who received placebo, also achieved higher rates of early remission at week 16 and continuous remission over weeks 16 to 52.

RHB-104 was found to be generally safe and well-received. Both treatment groups experienced similarly low rates of serious side effects and drug discontinuation due to treatment.

The Tel Aviv, Israel-based specialty biopharmaceutical company will continue to explore other goals of the study as additional data becomes available in the coming months.

"We continue to analyze the study data and plan to meet with key opinion leaders and the U.S. Food and Drug Administration to present the data package and discuss the development path to potential approval of RHB-104," Ira Kalfus, RedHill's medical director, said in the company's July 30 press release.

As of 2017, about 1.5 million people worldwide were diagnosed with Crohn's disease, according to the company. Global sales of Crohn's disease therapies are estimated to exceed $10 billion in 2018.

After an early surge, Redhill Biopharma's shares closed down 7.21% to $8.75 at 4 p.m. ET.