Areteia Therapeutics Announces Publication of Phase II Data of Oral Dexpramipexole in Eosinophilic Asthma
Areteia Therapeutics, Inc. (“Areteia”) today announced that results from the Phase II EXHALE-1 study of dexpramipexole have been published online in the Journal of Allergy and Clinical Immunology (JACI). The study sought to evaluate the safety and efficacy of dexpramipexole in lowering blood and airway eosinophilia in subjects with eosinophilic asthma.
Dexpramipexole significantly reduced AEC at week 12 across all doses tested, with 77% and 66% reductions relative to placebo in the 150-mg and 75-mg twice daily (BID) dose groups, respectively. Dexpramipexole reduced the exploratory end point of nasal eosinophil peroxidase, a biomarker of tissue eosinophilic inflammation, in both the 150-mg BID and the 75-mg BID groups. Clinically meaningful improvements in lung function as measured by forced expiratory volume (FEV1) were observed starting at week 4. Dexpramipexole displayed a favorable safety profile.
About the EXHALE-1 STUDY
The study was a randomized, double-blind, placebo-controlled proof-of-concept trial in adults with inadequately controlled moderate to severe asthma and AEC greater than or equal to 300/μL. Subjects were randomly assigned (1:1:1:1) to dexpramipexole 37.5-mg BID, 75-mg BID or 150-mg BID or placebo. The primary end point was the relative change in AEC from baseline to week 12. Prebronchodilator FEV1 week 12 change from baseline was a key secondary end point. Nasal eosinophil peroxidase was an exploratory end point.
A total of 103 subjects were randomly assigned to dexpramipexole 37.5-mg BID (N = 22), 75-mg BID (N = 26), 150-mg BID (N = 28), or placebo (N = 27). Dexpramipexole significantly reduced placebo-corrected AEC week 12 ratio to baseline, in both the 150-mg BID (ratio, 0.23; 95% CI, 0.12-0.43; P < .0001) and the 75-mg BID (ratio, 0.34; 95% CI, 0.18-0.65; P = .0014) dose groups, corresponding to 77% and 66% reductions, respectively. Dexpramipexole reduced the exploratory end point of nasal eosinophil peroxidase week 12 ratio to baseline in the 150-mg BID (median, 0.11; P = .020) and the 75-mg BID (median, 0.17; P = .021) groups. Placebo-corrected FEV1 increases were observed starting at week 4 (nonsignificant).
Overall, dexpramipexole was found to be safe and well tolerated. Rates of adverse events were balanced across treatment arms, with no serious adverse events or discontinuations due to adverse events reported. Of 76 dexpramipexole-treated subjects, 74 (97%) completed the primary assessment phase on the study drug.
For more information on the study publication and results: https://www.jacionline.org/action/showPdf?pii=S0091-6749%2823%2900709-1
About Areteia Therapeutics
Areteia Therapeutics, Inc. (areteiatx.com) is a clinical stage biotechnology company whose purpose is to develop and deliver novel Inflammation and Immunology (I&I) therapies that put respiratory patients in better control of their disease – and back in control of their lives. Our initial focus is 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 III clinical trials, secure commercial supply, and pursue potential next-generation medicines.
Areteia has initiated late-stage development of dexpramipexole in eosinophilic asthma, including three Phase III clinical trials in partnership with Population Health Partners’ development unit, Validae Health.
Dexpramipexole is an oral small molecule eosinophil lowering drug currently in Phase III development for eosinophilic asthma. Dexpramipexole inhibits 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 dexpramipexole resulted in a significant, dose-dependent reduction in blood absolute eosinophil count at all doses tested (twice daily dexpramipexole doses of 37.5-mg, 75-mg, or 150-mg) 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 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, 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.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Settlement Administrator Angeion Group Announces Proposed Settlement In U.S. Dollar LIBOR-Based Instrument Class Action22.9.2023 16:00:00 EEST | Press release
There are lawsuits impacting individuals and institutions that entered into over-the-counter financial derivative and non-derivative instruments directly with 17 banks and that received payments tied to U.S. Dollar LIBOR. A Settlement totaling $101 million has been reached with Coöperatieve Rabobank U.A. (“Rabobank”), Lloyds Banking Group plc, Lloyds Bank plc, HBOS plc, and Bank of Scotland plc (together, “Lloyds”), Royal Bank of Canada (“RBC”), and Portigon AG and Westdeutsche Immobilien Servicing AG (together “Portigon”). Earlier settlements totaling $680 million were reached with Barclays, Citibank, Deutsche Bank, HSBC, MUFG, Norinchukin, and SocGen bringing the total settlement amount to $781 million. The remaining Non-Settling Defendants include Bank of America, Credit Suisse, JPMorgan Chase, Royal Bank of Scotland, and UBS. What does the Settlement provide? The Settlement will create a Settlement Fund totaling $101 million that will be used to pay eligible Class Members who submi
Kenvue to Announce Third Quarter 2023 Results on October 26, 202322.9.2023 13:30:00 EEST | Press release
Kenvue Inc. (NYSE: KVUE) (“Kenvue”), the world’s largest pure-play consumer health company by revenue, will announce its financial results for the third quarter ending October 1, 2023, before market open on October 26, 2023. The company will host a conference call and webcast at 8:30 a.m. Eastern Time to discuss its third quarter results. The conference call can be accessed by dialing 877-407-8835 from the U.S. or 201-689-8779 from international locations. A live webcast of the conference call will be available at https://investors.kenvue.com. A replay will be available approximately two hours after the live event. About Kenvue Kenvue is the world’s largest pure-play consumer health company by revenue. Built on more than a century of heritage, our iconic brands, including Aveeno®, BAND-AID® Brand Adhesive Bandages, Johnson’s®, Listerine®, Neutrogena® and Tylenol®, are science-backed and recommended by healthcare professionals around the world. At Kenvue, we believe in the extraordinary
OS Achieves 800-Puff Milestone with FEELM Max Technology22.9.2023 12:34:00 EEST | Press release
A significant mark in the vaping industry was set when OS Vape, a pioneering disposable product series from OS, showcased its dynamic range at the InterTabac from September 14th to 16th in Germany. Recognized as a leading brand in Germany's shisha product market, OS boasts an extensive local network of channels. Drawing upon this rich resource base, OS's foray into the disposable e-cigarette domain promises consumers enhanced puff counts, cost-efficiency, and unparalleled vapor consistency. As revealed by Future Marketing Insights, Europe's disposable market witnessed a substantial surge, accounting for a 32.3% revenue share in 2022. This robust growth underscores the escalating consumer preference for hassle-free, smokeless alternatives that eliminate the need for recharges or refills. The evolution of the disposable sector brings heightened convenience and a broader array of choices for consumers. Capitalizing on this trend, OS, through its innovative product series and leveraging it
Earnix Announces New London Office, Unveils New Tech and Launches Global Modelling Contest at Earnix Eˣcelerate Summit 202322.9.2023 11:00:00 EEST | Press release
Earnix, the global provider of intelligent, SaaS solutions for insurers and banks, celebrated its 12th annual Eˣcelerate Summit by announcing a new London office to collaborate with its growing customer base, unveiling Model Accelerator, and launching its first global modelling contest. Held September 20-21 in London, Earnix Eˣcelerate brought together hundreds of financial services business leaders to discuss insurance insights, perspectives, case studies and approaches impacting the evolution of the industry. “Earnix Eˣcelerate was a world-class event dedicated to discussing industry challenges and discovering the latest technology innovation to address them,” said Karun Arathil, senior analyst, Celent. “I found the forum engaging and interactive, and it was great to exchange ideas and gain perspective with industry leaders from around the world.” In other news, Earnix announced a new upgraded office presence in London, located in Devonshire Square. The space affords local employees
Europe’s Enterprises Look to Providers to Bridge the CX Gap22.9.2023 11:00:00 EEST | Press release
Enterprises throughout Europe are rapidly moving from in-house operations to external service providers to meet the growing demand for an enhanced contact center customer experience (CX), according to a new research report published today by Information Services Group (ISG) (Nasdaq: III), a leading global technology research and advisory firm. The 2023 ISG Provider Lens™ Customer Experience Services report for Europe finds that most executives in Europe and worldwide consider CX a top strategic priority and intend to “completely protect” CX from cost optimization programs. Providers are responding to this increased demand by delivering advanced, location-independent CX with high AI and automation content, the report says. “Over the past few years, the need for resilient and advanced digital CX has increased dramatically,” said Jill Stabler, partner, ISG Enterprise. “This has led to a corresponding surge of activities in this space.” Technology has played a crucial role in shaping the C
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.Visit our pressroom