Celgene Corporation (NASDAQ:CELG) announced detailed results from the maintenance phase of the TOUCHSTONE phase 2 clinical trial of Ozanimod, an investigational compound, in patients with moderate to severe ulcerative colitis at the American College of Gastroenterology (ACG) Annual Scientific Meeting in Honolulu. In the trial, a significantly greater proportion of patients on Ozanimod achieved or maintained clinical remission at 32 weeks compared with those on placebo.
“Along with the previously reported results from the induction phase of this trial, data from the maintenance phase suggest that orally administered Ozanimod has the potential to help patients with moderate to severe ulcerative colitis,” said Dr. Stephen Hanauer, Medical Director, Northwestern Medicine Digestive Health Center, and Professor of Medicine-Gastroenterology and Hepatology, Northwestern University Feinberg School of Medicine.
The TOUCHSTONE trial evaluated the efficacy and safety of 0.5 mg and 1 mg doses of Ozanimod compared with placebo after eight weeks of treatment (induction phase) in 197 patients with moderate to severe ulcerative colitis. The primary endpoint was the proportion of patients in remission at week 8. Secondary endpoints were: the proportion of patients achieving a clinical response, the proportion of patients with mucosal improvement and the change from baseline in Mayo score. Previously reported results showed TOUCHSTONE met its primary endpoint and secondary endpoints with statistical significance for patients on the 1 mg dose of Ozanimod versus placebo in the 8-week induction phase.
For the maintenance phase, 103 patients who achieved a clinical response at week 8 (reduction in Mayo score of ≥3 and ≥30 percent with a decrease in rectal bleeding score of ≥1 or a rectal bleeding score ≤1) continued with their original treatment for an additional 24 weeks; of these, 91 patients completed 32 weeks of treatment.
Twenty one percent (14/67) of patients on Ozanimod 1 mg achieved or maintained clinical remission at week 32 [compared with 6 percent (4/65) on placebo (p=0.0108) and clinical response at week 32 was achieved or maintained by 51 percent (34/67) and 20 percent (13/65) of patients, respectively (p=0.0002)].
Mucosal improvement was also significantly more likely with Ozanimod 1 mg than with placebo at week 32 [22/67 (32.8 percent) vs. 8/65 (12.3 percent); p=0.0046)].
Adverse events (AEs) occurred in 11/42 (26.2 percent) patients in the Ozanimod 1 mg arm, 4/36 (11.1 percent) in the Ozanimod 0.5 mg arm and 8/25 (32.0 percent) in the placebo arm. The most common AEs were worsening of ulcerative colitis (1, 0 and 2 patients, respectively) and urinary tract infection (0, 1 and 1). No AEs of special interest (cardiac, pulmonary, ophthalmologic, hepatic, malignancy or serious infection) were reported during the maintenance phase.
“Ozanimod has the potential to offer a novel oral therapeutic approach for patients with ulcerative colitis, who need new therapies,” said Scott Smith, President, Celgene Inflammation & Immunology. “We are pleased with these safety and efficacy results, which give us confidence as we move forward with our phase 3 clinical trial.” (Original Source)
Shares of Celgene Corporation closed last Friday at $117.88. CELG has a 1-year high of $140.72 and a 1-year low of $87.12. The stock’s 50-day moving average is $117.15 and its 200-day moving average is $118.99.
On the ratings front, Celgene been the subject of a number of recent research reports. In a report issued on October 16, RBC analyst Michael Yee reiterated a Buy rating on CELG, with a price target of $150, which represents a potential upside of 27.2% from where the stock is currently trading. Separately, on October 13, Jefferies Co.’s Brian Abrahams maintained a Buy rating on the stock and has a price target of $140.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Michael Yee and Brian Abrahams have a total average return of 3.2% and 28.2% respectively. Yee has a success rate of 54.3% and is ranked #1053 out of 3788 analysts, while Abrahams has a success rate of 68.9% and is ranked #98.
The street is mostly Bullish on CELG stock. Out of 10 analysts who cover the stock, 9 suggest a Buy rating and one recommends to Hold the stock. The 12-month average price target assigned to the stock is $152.33, which represents a potential upside of 29.2% from where the stock is currently trading.
Celgene Corp is a biopharmaceutical company. It is engaged in the discovery, development and commercialization of therapies designed to treat cancer and immune-inflammatory related diseases.