Global pharmaceutical company Allergen has exercised its option to purchase Motus Therapeutics, a wholly owned subsidiary of the Rhythm Holding Company.
As a result of exercising its option to buy Motus Therapeutics, Allergan will pay the exercise price of $200m upon closing to Rhythm Holding.
In addition, Rhythm Holding will be eligible for a contingent payment upon first commercial sale of relamorelin.
Allergan previously made $47m in payments associated to the option-to-acquire Motus and the relamorelin Phase 2b clinical trial.
The closure of Allergan’s Motus Therapeutics acquisition is expected to occur by the end of this year, subject to customary closing conditions.
Meanwhile, Allergan and Rhythm Holding Company, owner of biopharmaceutical company Motus Therapeutics, has reported top-line results of a Phase 2b clinical trial analysing the efficacy and safety of relamorelin (RM-131), Motus’ ghrelin agonist, for the treatment of gastroparesis in patients suffering with type 1 and type 2 diabetes.
In the Phase 2b trial, relamorelin administered for 12 weeks indicated substantial efficacy for the key diabetic gastroparesis symptoms of nausea, post-prandial fullness, abdominal pain and bloating (measured both individually and as a composite endpoint), along with a potent prokinetic effect on gastric motility.
Relamorelin is a potent ghrelin agonist in development for the treatment of diabetic gastroparesis.
Derived from the natural ghrelin sequence, relamorelin has been optimised to stimulate gastrointestinal (GI) motility, with greater potency and enhanced stability and pharmacokinetics.
The US Food and Drug Administration (FDA) has granted Fast Track review status to relamorelin for the treatment of diabetic gastroparesis.
Patients receiving relamorelin also found an approximately 75% reduction in vomiting frequency across all doses compared to baseline (the primary endpoint), similar to the impact seen in the Phase 2a trial.
However, a high placebo response for vomiting frequency, extending well beyond that expected from previous studies, restricted the ability to indicate treatment efficacy on the vomiting frequency endpoint.
The Phase 2b trial was intended to evaluate the impact of relamorelin on the key signs and symptoms of gastroparesis identified in the draft FDA guidance for gastroparesis, in addition to gastric emptying and safety in patients with moderate-to-severe diabetic gastroparesis and with symptoms of vomiting at baseline.
The randomised, double-blind, placebo-controlled trial analysed the safety and efficacy of dosing regimens ranging from 10mcg to 100mcg administered twice daily over three months.
A total of 393 patients with diabetic gastroparesis were enrolled at clinical sites in the US and Europe .
Allergan executive vice president of global research and development David Nicholson said: “The clinical results with relamorelin in this Phase 2b trial in diabetic gastroparesis are very encouraging.
“Based on these results and the results observed in the earlier phase 2a trial, Allergan has exercised its option to acquire Motus Therapeutics and intends to initiate Phase 3 clinical trials of relamorelin.
“We very much look forward to sharing this phase 2b data with the US Food and Drug Administration and to discussing our plans to conduct Phase 3 trials.”
Overall, relamorelin was safe and well-tolerated in the phase 2b study with high compliance and completion rates over the course of the trial.
There was some evidence of dose-related adverse events related to worsening of glycemic control in some patients.