15 March 2023 - - The first patients have been dosed in both the EXHALE-2 and EXHALE-4 trials as part of US-based Areteia Therapeutics' overall Phase III clinical program investigating the efficacy and safety of oral dexpramipexole in severe eosinophilic asthma, the company said.

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.

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.

Areteia Therapeutics 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 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 USD 350m 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.