Eosinophilic Asthma

CHAPEL HILL, N.C.--( BUSINESS WIRE )--Areteia Therapeutics, Inc. (“Areteia”), a clinical-stage biotechnology company developing novel inflammation and immunology therapies, with an initial focus on severe eosinophilic asthma, today announced that the Company will present at the 43 rd Annual J.P. Morgan Healthcare Conference on Tuesday January 14, 2025 at 1:30 p.m. PT in San Francisco, CA. A copy of the presentation will be posted on the Company’s website following the presentation. Event: J.P. Morgan Healthcare Conference Venue: The Westin St. Francis, San Francisco, CA Date: January 14, 2025 Time: 1:30 p.m. - Pacific Time Location: Golden Gate room (32 nd Floor), The Westin St. Francis Presenter: Jorge Bartolome, Chief Executive Officer About Areteia Areteia is a clinical-stage biotechnology company engaged in the development of a potential first-in-class oral therapeutic remedy for diseases associated with elevated eosinophil levels with an initial focus on severe eosinophilic asthma. The Company has advanced its investigational drug, dexpramipexole, into three separate Phase III clinical trials, including two 52-week global exacerbation trials and one 24-week lung function trial. Areteia’s team is committed to developing and delivering novel inflammation and immunology therapies with the goal of putting respiratory patients in better control of their disease and back in control of their lives. To learn more, please visit www.areteiatx.com 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, ARCH Venture Partners, Viking Global Investors, Marshall Wace, GV, Saturn Partners, Sanofi, Maverick Capital, and Population Health Partners, has committed to invest up to $425 million in Series A financing to establish Areteia and advance dexpramipexole through Phase III clinical trials, secure commercial supply, and pursue potential next-generation medicines. About Dexpramipexole Dexpramipexole, an investigational drug, is an oral small molecule that has been shown to lower eosinophil levels in blood and tissue and is currently in Phase III development for treatment of adults and adolescents with severe eosinophilic asthma. Dexpramipexole’s proposed mechanism of action is to inhibit the maturation of eosinophils in the bone marrow, based on evidence from cell cultures and human biopsies, thereby lowering peripheral blood eosinophil levels. Most recently in a Phase II study in patients with moderate-to-severe eosinophilic asthma, treatment with our investigational drug dexpramipexole resulted in a significant, dose-dependent reduction in blood absolute eosinophil count at all doses tested (twice daily dexpramipexole dihydrochloride doses of 37.5-mg, 75-mg, or 150-mg) compared to placebo. The investigational drug 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 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, we believe that the oral administration of the investigational drug dexpramipexole acts to lower eosinophils. Currently approved injectable anti-IL-5/5R biologic therapies provide clinical benefit through eosinophil lowering. The global asthma biologic market is experiencing robust growth having doubled in the last three years and is valued today at approximately $10 billion. If approved as a first-to-market oral, dexpramipexole could provide an alternative to injectable biologics.

According to the official announcement from the National Medical Products Administration (NMPA), Platinum Biotechnology (Beijing) Co., Ltd. has received conditional approval for its stem cell therapy "Aimi Mitosai," which is used to treat acute graft-versus-host disease (GVHD) in patients aged 14 and older, primarily affecting the digestive tract and resistant to hormone therapy. This therapy has become the first approved stem cell therapy in China. In addition, AstraZeneca's new indication application for Osimertinib has also been officially approved. This drug will be used to treat adult patients with locally advanced unresectable (stage III) non-small cell lung cancer (NSCLC) who have not shown disease progression after receiving platinum-based radical chemoradiotherapy and have epidermal growth factor receptor (EGFR) exon 19 deletion (Ex19del) or exon 21 (L858R) substitution mutations. The NMPA also announced the approval of the marketing applications for Lanapavir tablets and injections submitted by Gilead Sciences. Lanapavir is an HIV-1 capsid inhibitor that will provide a new treatment option for HIV-infected individuals who do not respond effectively to existing therapies, requiring administration only twice a year. This drug has previously been approved in the EU, the U.S., and other regions. Johnson & Johnson's innovative compound drug "Maxiten" has been submitted for marketing approval in China for the treatment of pulmonary arterial hypertension (PAH). PAH is a rare progressive and life-threatening vascular disease characterized by the constriction of small pulmonary arteries and increased pulmonary circulation pressure, which may eventually lead to right heart failure. Multiple drugs have been approved for the treatment of PAH. GlaxoSmithKline (GSK)'s depemokimab has also been submitted for marketing approval in China. Based on the progress of clinical trials, the expected indication is for severe eosinophilic asthma (SEA). Depemokimab is a new generation anti-IL-5 monoclonal antibody developed by GSK, featuring a longer half-life, high binding affinity, and potency, requiring only one injection every six months. Innovent Biologics' next-generation ROS1 tyrosine kinase inhibitor (TKI) Dabrutinib's second New Drug Application (NDA) has also been approved by the NMPA for the treatment of adult patients with ROS1-positive locally advanced or metastatic NSCLC. This approval is based on positive results from the Phase II clinical study TRUST-I (NCT04395677).

GSK’s Nucala was approved in the US for severe asthma with an eosinophilic phenotype treatment. Credit: MAXSHOT.PL / Shutterstock. The China National Medical Products Administration (NMPA) has approved GSK’s Nucala (mepolizumab) as an add-on treatment with intranasal corticosteroids to treat chronic rhinosinusitis with nasal polyps (CRSwNP) in the adult population. This marks the third indication for an interleukin-5 (IL-5) targeting monoclonal antibody, Nucala, in the region for an IL-5 mediated condition. The approval of the antibody offers an alternative for those who find systemic corticosteroids and surgery ineffective. The decision by the NMPA is underpinned by the Phase III MERIT trial outcomes, which included subjects from China, Russia, and Japan and is supported by the global Phase III SYNAPSE study. GSK Respiratory/Immunology R&D global head and SVP Kaivan Khavandi said: “We are delighted that Nucala has been approved in China as a treatment for CRSwNP, a chronic condition for which new and effective treatments are needed. “Patients now have a non-surgical option available to them and an alternative to repeated exposure to oral corticosteroids.” The MERIT trial assessed the safety and efficacy of the therapy for 52 weeks against a placebo. The change from baseline in nasal obstruction visual analogue scale (VAS) score and endoscopic nasal polyp score at week 52 was the co-primary endpoint. According to the findings from 163 trial subjects, it is determined that the therapy ‘significantly improved’ nasal obstruction VAS score and reduced nasal polyp score. Previously approved in China for severe eosinophilic asthma in adult and adolescent individuals of 12 years of age and above, and adults with eosinophilic granulomatosis with polyangiitis, the therapy was also granted approval in the US in 2015 for severe asthma with an eosinophilic phenotype. Chronic rhinosinusitis is a prevalent condition in China, affecting an estimated 107 million people. Approximately one-third of these individuals suffer from this condition, the company noted. Often associated with type 2 inflammation, CRSwNP is characterised by high levels of IL-5 in nasal polyp tissue and a tendency for nasal polyps to regrow post-surgery due to persistent inflammation.