Actavis ACT and biopharmaceutical company, Rhythm, announced the initiation of a phase IIb study on relamorelin. The study is assessing the efficacy and safety of relamorelin (10 mcg to 100 mcg) over three months for the treatment of gastroparesis in patients suffering from type I and II diabetes.
We note that Actavis has an exclusive option to acquire Rhythm Pharmaceuticals, a wholly owned subsidiary of Rhythm, on completing the phase IIb study.
Actavis had entered into an agreement with Rhythm in Oct 2014. As per the terms of the agreement Actavis gained the acquisition option along with the worldwide rights to relamorelin for an undisclosed amount.
Rhythm has already completed two phase II studies on relamorelin. In the first phase II study, patients suffering from diabetic gastroparesis and treated with relamorelin (10 mcg twice daily) showed statistically significant improvements in gastric emptying and vomiting symptoms. Also, results showed statistically significant improvements in other gastroparesis symptoms in a pre-specified subgroup.
In the other study, a phase IIa on relamorelin in chronic constipation patients, those treated with the candidate showed statistically significant improvements in spontaneous bowel movements and in lower gastrointestinal transit. Relamorelin was generally well tolerated in both the studies.
Relamorelin enjoys a Fast Track review status in the U.S. for the treatment of diabetic gastroparesis.
Ironwood Pharmaceuticals IRWD is also developing a candidate (IW-9179) for diabetic gastroparesis. The candidate is in a phase IIa study with data expected in the first half of 2016.
Actavis currently carries a Zacks Rank #2 (Buy). Some other favorably ranked stocks in the health care sector include Akorn, Inc. AKRX and Mallinckrodt MNK. Both hold a Zacks Rank #1 (Strong Buy).
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