Areteia Therapeutics Granted ILAP Designation from UK MHRA for Oral Dexpramipexole for Eosinophilic Asthma

Areteia Therapeutics today announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted an Innovation Passport under the Innovative Licensing and Access Pathway (ILAP) to dexpramipexole, an eosinophil lowering small molecule, that has recently entered Phase III clinical development.

The Innovation Passport is the first step in the ILAP process, triggering the MHRA and its partner agencies, including the National Institute for Health and Care Excellence (NICE), the Scottish Medicines Consortium (SMC) and National Health Service (NHS) England, to chart a roadmap for regulatory and development milestones with the goal of early patient access in the U.K.

“It is great to see that in granting an Innovation Passport, the MHRA is as excited as we are about the potential for dexpramipexole,” said Jorge Bartolome, Chief Executive Officer of Areteia Therapeutics. He added, “If approved, dexpramipexole would represent the first oral drug for eosinophilic asthma patients, offering an alternative to injectable biologics.”

About Dexpramipexole

Dexpramipexole inhibits the maturation and release of eosinophils in bone marrow, based on evidence from cell cultures and human biopsies, thereby lowering peripheral blood eosinophil levels. Most recently in a Phase II study (EXHALE-1) in patients with moderate-to-severe eosinophilic asthma, treatment with dexpramipexole resulted in a significant, dose-dependent reduction in blood absolute eosinophil count at all doses tested (dexpramipexole doses of 37.5 mg, 75 mg, or 150 mg twice daily) compared to placebo. Dexpramipexole was well tolerated in the trial, with adverse events balanced across treatment and placebo groups, no serious adverse events, and no adverse events leading to discontinuation.

About Areteia Therapeutics

Areteia Therapeutics (areteiatx.com) is a clinical stage biotechnology company committed to putting asthma patients in better control of their disease and lives by developing the first potential oral drug for eosinophilic asthma. Areteia’s lead drug candidate is dexpramipexole, a first-in-class oral eosinophil maturation inhibitor. Areteia was created by Population Health Partners and Knopp Biosciences. A syndicate of leading life sciences and strategic investors led by Bain Capital Life Sciences with participation from Access Biotechnology, GV, ARCH Venture Partners, Saturn Partners, Sanofi, Maverick Capital, and Population Health Partners, has committed to invest up to $350 million in Series A financing to establish Areteia and advance dexpramipexole through Phase 3 clinical trials, secure commercial supply, and pursue potential next-generation medicines. Areteia is conducting late-stage development including three Phase 3 clinical trials of dexpramipexole in partnership with Population Health Partners’ development unit, Validae Health.

About Eosinophilic Asthma

Asthma disrupts the lives of more than a quarter of a billion people worldwide. More than half of asthma patients have eosinophilic asthma, which is driven by an oversupply of eosinophils, a type of white blood cell, in blood and tissue. By inhibiting the maturation of eosinophils, oral dexpramipexole acts in a way similar to injectable anti-IL-5 biologic therapies. The asthma biologic market is experiencing growth of 10% per year and is valued at around $8 billion, with IL-5 biologic therapies representing greater than $3 billion of that figure. If approved as a first-to-market oral drug, dexpramipexole could provide a compelling alternative to injectable biologics, and could potentially be used earlier in the asthma treatment paradigm to prevent progression of disease.

About ILAP

The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) launched ILAP at the start of 2021 in order to accelerate the development and access to promising medicines in the early stages of development. The pathway, part of the UK’s plan to attract life sciences development in the post-Brexit era, features enhanced input and interactions with MHRA and other stakeholders. Other benefits of ILAP include access to a range of development tools, such as the potential for a 150-day accelerated Marketing Authorization Application (MAA) assessment, rolling review and a continuous benefit risk assessment.

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Contact information

Tamsin Berry Tamsin.Berry@areteiatx.com

Mark Kreston Mark.Kreston@areteiatx.com