Clementia Pharmaceuticals, a clinical-stage company innovating treatments for individuals with ultra-rare bone disorders, has completed patient enrolment in the Phase 3 stage of MOVE Trial.
This trial is Clementia’s registrational Phase 3 clinical study analysing the safety and efficacy of palovarotene to treat patients suffering with fibrodysplasia ossificans progressiva (FOP).
For the study, a total of 99 patients were enrolled at 15 sites across 11 countries globally.
Depending on the early completion of enrolment, Clementia will carry out two interim data analyses next year.
The first will be conducted when the first 35 enrolled patients have had their 12-month whole body CT (WBCT) scans. This is expected in the second quarter of 2019.
The second analysis will be conducted after all enrolled patients have had their 12-month WBCT scans, which is anticipated in the second half of 2019.
The final 24-month results from the study are expected in the fourth quarter of 2020.
Clementia president and chief executive officer Clarissa Desjardins said: “The enthusiastic response to the MOVE Trial amongst the FOP medical and patient communities has resulted in the completion of enrolment in the MOVE Trial four months ahead of schedule.
“I’d like to thank the patient participants and their families, as well as our study investigators and their clinical teams, whose dedication has helped advance palovarotene for the potential future treatment of FOP patients who have no approved treatment options today.”
All patients in the MOVE Trial get a single daily dose of palovarotene, with increased dosing at the time of a flare-up.
Data from Clementia’s natural history study (NHS) will serve as the control.
Patients are treated with palovarotene for 24 months, with three planned interim analyses.
Palovarotene is an RARγ agonist being developed as a treatment for patients with ultra-rare and debilitating bone diseases, including fibrodysplasia ossificans progressiva (FOP) and multiple osteochondromas (MO), as well as other diseases.
FOP is a rare, severely disabling disorder characterised by heterotopic ossification (HO), or bone that forms outside the normal skeleton in muscles, tendons or soft tissue.