Mapi Pharma engages CRO PRA Health for multiple sclerosis trial
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Mapi Pharma engages PRA Health Sciences as CRO for Phase III multiple sclerosis trial

By Sean Rai-Roche 20 Jan 2021

GA Depot is a long-acting version of Teva Pharmaceutical’s Copaxone (glatiramer acetate). Copaxone garnered its FDA approved for RMS in 1996 and is administered either daily or three times per week. GA Depot is being investigated for administration every four weeks. Both immunomodulators are administered via injection.

Mapi Pharma engages PRA Health Sciences as CRO for Phase III multiple sclerosis trial
GA Depot is a long-acting version of Teva Pharmaceutical’s Copaxone (glatiramer acetate). Credit: Ralwell/Shutterstock.com.

Mapi Pharma is working with the CRO PRA Health Sciences for its Phase III trial investigating glatiramer acetate depot (GA Depot) for relapsing forms of multiple sclerosis (RMS), said chairman and CEO Ehud Marom.

PRA was chosen based on its experience and approach in running MS trials, as well as its competitive price, added Alex Mogel, Mapi vice president of corporate development. Ness Ziona, Israel-based Mapi has a Phase III trial oversight team working with the full-service CRO, noted Marom. PRA did not respond to a comment request.

The 960-patient, placebo-controlled Phase III trial has 96 sites in the US, Eastern Europe and Israel, according to ClinicalTrials.gov. In a 21 December media release, Mapi announced it had surpassed its 60% recruitment milestone. The trial has a primary endpoint investigating annualised relapse rate with a 52-week timeframe.

GA Depot is a long-acting version of Teva Pharmaceutical’s Copaxone (glatiramer acetate). Copaxone garnered its FDA approved for RMS in 1996 and is administered either daily or three times per week. GA Depot is being investigated for administration every four weeks. Both immunomodulators are administered via injection.

Investor, partner talks welcome

Mapi is looking to raise around $50m for its pipeline development, said Marom, although he did not provide additional details such as a timeline. Mapi is open to talks with large investors and is already speaking with large global investment banks, Mogel added.

Mapi would be open to old investors reinvesting, Mogel said. Mapi previously raised funding from Israel-based investment firms Shavit Capital Fund and aMoon, with each providing $10m in 2015 and 2017, respectively. Mapi also previously raised funds from Viatris and China-based financers, Marom added. GA Depot is Mapi’s lead asset, with a Phase II trial in primary progressive MS (PPMS) in addition to the aforementioned Phase III RMS trial. The company also has other pharmacokinetic trials investigating new formulations of already approved drugs.

Mapi is open to discussions about partnerships, with arrangements potentially spanning drug development all the way to commercialisation, noted Marom, although he did not indicate timelines. Mapi can support the research and development of larger companies’ pipelines in parallel to Mapi’s own pipeline, he explained.

Mapi is partnered with Viatris for GA Depot, with both companies collaborating on the development and commercialisation, and Viatris holding global marketing rights. Mapi also has two licensing partners in China, Jingxin Pharmaceutical and Shanghai Pharmaceutical, although the terms of these agreements are not public.

Mapi will only consider going public once it has two assets in Phase III, said Marom. The company website states a Phase III GA Depot trial in PPMS is anticipated for 2022. The company will be listed on the NASDAQ, he added, noting it would welcome investors who can help facilitate an IPO.

Sean Rai-Roche is a Reporter for Clinical Trials Arena parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.