Areteia’s dexpramipexole holds potential to redefine respiratory health: GlobalData

During the J.P. Morgan 43rd Annual Healthcare Conference in January 2025, Areteia Therapeutics’s CEO, Jorge Bartolome, presented a detailed review of its achievements in 2024 and outlined its 2025 plans to advance innovation in the respiratory space with its flagship candidate dexpramipexole dihydrochloride, the first oral therapy targeting eosinophilic asthma. With multiple ongoing clinical trials and a strategic focus on regulatory approvals, Areteia could be well-positioned to transform the treatment landscape for severe respiratory diseases, according to GlobalData.

Sravani Meka, Senior Pharmaceutical Analyst at GlobalData, states, “The current treatment landscape for severe asthma is primarily biologics, which are either administered intravenously or subcutaneously. With the Phase 3 program one step closer to reaching study completion, if approved, dexpramipexole can transform the treatment landscape by addressing unmet needs for patients facing barriers to injectable treatments.”

A major focus of the presentation was the progress of the EXHALE program, dexpramipexole dihydrochloride’s pivotal trials. Significant advancements have been made in the Phase 3 asthma trials (EXHALE-2, EXHALE-3, and EXHALE-4), with EXHALE-4 now fully enrolled and top-line results expected in Q3 2025.

Additionally, the SUSPIRE-1 trial, investigating dexpramipexole’s potential in COPD, is also fully enrolled, with data readouts anticipated later in 2025. Bartolome also highlighted dexpramipexole’s strong differentiation within the competitive landscape. Data from Phase 2 trials demonstrated biologic-like efficacy, including significant reductions in blood eosinophils and notable improvements in lung function (FEV1).

Meka add,“Despite the progress in the Phase 3 program, Areteia faces increasing competition, particularly from established biologic therapies by GSK and AstraZeneca. Its success hinges on achieving strong clinical data, rapid regulatory approvals, and effective market positioning. Anticipated trial results later this year will be critical in determining whether dexpramipexole can meet the unmet needs of patients and disrupt current treatment paradigms.”

Bartolome also offered a forward-looking perspective on Areteia’s mission to revolutionise respiratory care. Backed by $425 million in Series A funding and a seasoned leadership team, the company is poised to address significant medical and economic challenges in asthma and COPD. With dexpramipexole at the forefront, Areteia aims to drive innovation and expand its pipeline to deliver life-changing therapies for patients worldwide.

Meka concludes, “While Areteia’s funding rounds have proved to be successful, positive trial results in 2025 could attract collaborations for co-development, licensing, or commercialisation, leveraging Areteia’s innovation to address unmet needs in asthma and COPD. Strategic alliances could accelerate global market reach and pipeline expansion, solidifying Areteia’s leadership in respiratory care.”