In the U.S., Copaxone (glatiramer acetate injection, marketed by Teva Pharmaceutical) is the standard therapy for relapsing-remitting multiple sclerosis (RRMS), which is the most prevalent type of the disease.
GA Depot, Israel-based Mapi’s lead product, also contains glatiramer acetate and is a long-acting depot formulation injection given once every four weeks, compared to Copaxone’s more frequent daily or three times a week dosage.
PPMS is characterized by a gradual deterioration of neurologic function starting with the onset of symptoms, without early relapses or remissions. The prospective, multicenter Phase 2a trial (NCT03362294) will address GA Depot’s safety and efficacy in slowing the progression of disability in PPMS patients.
The study will be open label, which means that both investigators and participants know what drug is being administered, and that no placebo control is used.
All patients will be given 40 mg of GA Depot through intramuscular administration once every four weeks for 52 weeks. The company anticipates enrolling from 12 to 24 PPMS patients who are not being treated, except for relief of symptoms. Researchers will periodically conduct safety assessments, check on vital signs, and perform physical, magnetic resonance imaging (MRI), and neurological exams.
After the treatment period, four weeks of follow-up will be conducted in a total of 17 medical visits. The study’s estimated completion date is December 2019. Patient recruitment is currently ongoing in medical centers in Israel (more information is available here).
The clinical potential of GA Depot was supported by the results of a recently completed one-year Phase 1/2 study (NCT02212886) in 24 patients with RRMS. The trial assessed the safety, tolerability, and efficacy of GA Depot in patients who switched from Copaxone therapy.
GA Depot demonstrated strong efficacy, as 84.6% of participants achieved no evidence of disease activity (NEDA), which combines the absence of relapses, no new MRI lesions, and no confirmed disability progression.
“GA Depot has presented early efficacy in RRMS patients and we hope this also benefits PPMS patients, which remains an important medical need,” Jerry S. Wolinsky, MD, a professor emeritus in neurology at The University of Texas Health Science Center at Houston, said in a press release.
“Our goal is that GA Depot will become a first-line treatment for both RRMS and PPMS patients,” said Ehud Marom, CEO and chairman at Mapi. The company is planning to start a Phase 3 trial to support a marketing application in the U.S. regarding the use of GA Depot in RRMS patients.
“Mapi is focused on bringing these products to the market and plans to raise additional capital to finance the Phase 3 trials for these medical indications,” Marom said.