Further building its gastrointestinal (GI) disease portfolio, Allergan plans to acquire Motus Therapeutics (formerly Rhythm Health), the GI-focused, wholly owned subsidiary of Rhythm Holding, for $200 million upfront plus an undisclosed sales milestone payment, the companies said today.
The acquisition is the third in 5 weeks through which Allergan has expanded its GI offerings. On September 20, Allergan disclosed plans to acquire Tobira Therapeutics for up to $1.695 billion, in a deal that would add two nonalcoholic steatohepatitis (NASH) candidates to its GI R&D pipeline. That same day, Allergan snapped up Akarna Therapeutics, another NASH drug developer, for $50 million upfront.
Allergan’s acquisition of Motus will include the company’s lead drug candidate relamorelin (RM-131), a ghrelin agonist being developed for diabetic gastroparesis.
In announcing the planned acquisition, Allergan and Motus also trumpeted positive topline results from a Phase IIb trial assessing relamorelin. The trial enrolled 393 patients with diabetic gastroparesis in a randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of dosing regimens ranging from 10 to 100 μg administered twice daily over 3 months.
According to the topline results, Allergan and Motus said, relamorelin showed “substantial” efficacy in relieving key diabetic gastroparesis symptoms of nausea, postprandial fullness, abdominal pain, and bloating, along with a potent prokinetic effect on gastric motility, following 12 weeks of treatment.
In the primary endpoint, patients receiving relamorelin experienced an approximately 75% reduction in vomiting frequency across all doses compared to baseline, an effect similar to that seen in a Phase IIa trial.
“Based on these results and the results observed in the earlier phase IIa trial, Allergan has exercised its option to acquire Motus Therapeutics and intends to initiate Phase III clinical trials of relamorelin,” David Nicholson, Allergan evp of global R&D, said in a statement.
However, the companies acknowledged an unusually high placebo response for vomiting frequency, extending well beyond that expected from previous studies—a factor they said limited the ability to demonstrate treatment efficacy on the vomiting frequency endpoint.
The companies said they plan to submit their data for presentation at a “major” GI medical conference in 2017.
Allergan agreed to pay $200 million upon closing of the acquisition, which is expected to occur by year’s end. Allergan also agreed to pay Rhythm an additional payment tied to the first commercial sale of relamorelin.
Allergan has spent a total $47 million between its option to acquire Motus and the Phase IIb trial.
Allergan’s planned acquisition of Motus is subject to customary closing conditions, the companies added.