Areteia Therapeutics announced today that the first patients have been dosed in both the EXHALE-2 and EXHALE-4 trials as part of its overall Phase III clinical program investigating the efficacy and safety of oral dexpramipexole in severe eosinophilic asthma. A total of three clinical studies are planned as part of the overall Phase III development program.
EXHALE-2 is a 52 week, randomized, double-blind, placebo-controlled global study (n=1,395 participants) which will evaluate the efficacy of dexpramipexole in reducing severe asthma exacerbations as compared to placebo as its primary endpoint. An additional global phase 3 study (titled EXHALE-3) is planned to similarly evaluate reduction in exacerbations as compared to placebo as its primary endpoint.
EXHALE-4 is a 24 week, randomized, double-blind, placebo-controlled global study (n=750 participants) which will evaluate change in lung function compared to placebo as its primary endpoint. Lung function will be measured by change in forced expiratory volume (FEV1).
“We are excited about dexpramipexole as a potential novel oral therapy for the millions of patients worldwide who are impacted by eosinophilic asthma. If approved, dexpramipexole would represent the first oral drug for these patients,” said Jorge Bartolome, Chief Executive Officer of Areteia Therapeutics.
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 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 approximately $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.
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