Ensifentrine

Data support Ohtuvayre™ (ensifentrine), as a first-in-class, selective, dual inhibitor of PDE3 and PDE4 in a broad COPD populationLONDON and RALEIGH, N.C., Sept. 30, 2024 (GLOBE NEWSWIRE) -- Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”) announces four oral presentations and two posters on analyses from its successful Phase 3 ENHANCE studies with Ohtuvayre (ensifentrine) for the treatment of chronic obstructive pulmonary disease (“COPD”) will be presented at CHEST Annual Meeting (“CHEST”) 2024. The analyses are published in the CHEST Annual Meeting on-line supplement. Ohtuvayre (ensifentrine) is a first-in-class selective dual inhibitor of the enzymes phosphodiesterase three and phosphodiesterase 4 (“PDE3 and PDE4”) that combines bronchodilator and non-steroidal anti-inflammatory effects in one molecule. Ohtuvayre is the first novel inhaled mechanism for the maintenance treatment of COPD in more than 20 years. The analyses will summarize the efficacy and safety of Ohtuvayre in subgroups of COPD patients including data supporting improvements in lung function, symptoms and quality of life, as well as reductions in the rate of exacerbations, regardless of COPD severity (moderate or severe), smoking status (current or former), and chronic bronchitis (with or without). Furthermore, an analysis of ensifentrine’s impact on reducing exacerbation rates and COPD-related healthcare resource utilization over 48 weeks will also be presented. “Ensifentrine is a remarkable addition to COPD therapy,” said William Stringer, MD, FCCP, Professor of Medicine in the David Geffen School of Medicine at UCLA. “It has the capacity to bronchodilate, reduce inflammation, augment mucociliary clearance, and reduce exacerbations in smokers and former smokers.” Details of Verona Pharma’s presentations and posters are listed below and linked to the CHEST website. In addition, the Company will present five presentations that will highlight the unmet need in COPD based on real world claims data. Oral presentation: Ensifentrine improved lung function, symptoms, and quality of life regardless of COPD severityPresenter: Jessica Bon, MD, Wake Forest University School of MedicineSession: Assessing Treatment Outcomes in Obstructive Lung Disease Oral presentation: Ensifentrine, a novel COPD treatment, reduced COPD-related healthcare resource utilization over 48 weeksPresenter: Emily Wan, MD, Brigham and Women’s Hospital and Harvard Medical SchoolSession: Emerging Treatments in Obstructive Lung Disease Oral presentation: Ensifentrine improved lung function in patients with moderate to severe COPD: a pooled analysis from the Phase 3 ENHANCE trialsPresenter: Diego J. Maselli Caceres, MD, FCCP, Division of Pulmonary Diseases and Critical Care, UT Health San AntonioSession: Emerging Treatments in Obstructive Lung Disease Oral presentation: Ensifentrine improved lung function and reduced exacerbation rate and risk in patients with COPD regardless of smoking statusPresenter: Amy Dixon, PharmD, Verona PharmaSession: Novel Therapeutic Targets and Interventions in Obstructive Lung Disease Poster 3513: Ensifentrine improved symptoms and quality of life in patients with moderate-to-severe COPD regardless of smoking statusPresenter: William Stringer, MD, FCCP, David Geffen School of Medicine at UCLASession: Novel Therapeutic Targets and Interventions in Obstructive Lung Disease Poster 4285: Ensifentrine improved symptoms and quality of life in patients with COPD regardless of bronchitis historyPresenter: Jill Ohar, MD, Wake Forest University School of MedicineSession: Lung Disease Abstracts Posters For further information please contact: Verona Pharma plcTel: +1-844-341-9901Victoria Stewart, Senior Director of InvestorRelations and CommunicationsIR@veronapharma.comArgot Partners(US Investor Enquiries)Tel: +1-212-600-1902verona@argotpartners.comTen Bridge CommunicationsInternational / US Media EnquiriesTel: +1-312-523-5016tbcverona@tenbridgecommunications.comLeslie Humbel About Ohtuvayre (ensifentrine) Ohtuvayre is the first inhaled therapy for the maintenance treatment of COPD that combines bronchodilator and non-steroidal anti-inflammatory activities in one molecule. Verona has evaluated nebulized Ohtuvayre in its Phase 3 clinical program ENHANCE (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) for COPD maintenance treatment. Ohtuvayre met the primary endpoint in both ENHANCE-1 and ENHANCE-2, demonstrating statistically significant and clinically meaningful improvements in lung function. A fixed-dose combination of ensifentrine and glycopyrrolate, a LAMA, is currently under development for the maintenance treatment of COPD. About Verona Pharma Verona Pharma is a biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of chronic respiratory diseases with significant unmet medical needs. Ohtuvayre (ensifentrine) is the Company’s first commercial product and the first inhaled therapy for the maintenance treatment of COPD that combines bronchodilator and non-steroidal anti-inflammatory activities in one molecule. Ensifentrine has potential applications in non-cystic fibrosis bronchiectasis, cystic fibrosis, asthma and other respiratory diseases. For more information, please visit www.veronapharma.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. All statements contained in this press release other than statements of historical fact should be considered forward-looking statements. Words such as “anticipate,” “believe,” “plan,” “expect,” “intend,” “may,” “potential,” “prepare,” “possible” and similar words and expressions are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding the potential benefits and efficacy of our drug Ohtuvayre and future poster presentations and academic publications pertaining to Ohtuvayre. These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from our expectations expressed or implied by the forward-looking statements, including, but not limited to, the efficacy of Ohtuvayre compared to competing drugs and the other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the period ended June 30, 2024 filed with the Securities and Exchange Commission (“SEC”) on August 8, 2024, as such factors may be updated from time to time in our other filings with the SEC. We disclaim any obligation to update or revise any forward-looking statement contained in this press release, even if subsequent events cause our views to change, except as required under applicable law.

The blockbuster Sanofi and Regeneron Pharmaceuticals drug Dupixent, already commercialized in several skin and lung disorders, has expanded its FDA-approval to chronic obstructive pulmonary disease (COPD), a progressive lung condition prevalent in smokers. The regulatory decision announced Friday permits Dupixent’s use as an add-on maintenance treatment of adults whose COPD is inadequately controlled by available therapies. The every-other-week injectable drug is now the first biologic therapy approved by the FDA for treating COPD. In COPD, damage to the lungs leads to inflamed airways that cause breathing difficulty, coughing, and wheezing. The disease can be caused by long-term exposure to inhaled irritants, which is why it’s prevalent in smokers. But non-smokers can also develop COPD. Standard treatment includes drugs and drug combinations that widen airways and reduce inflammation. presented by Health Tech What’s Keeping Healthcare CIOs Up at Night: How to Improve Patient Satisfaction by Handling Calls More Efficiently Health systems have spent billions on portals while investments in modernizing the voice channel — the dominant preference of healthcare consumers — have taken a backseat. By Stephanie Baum Dupixent is an antibody designed to block IL-13 and IL-4, two signaling pathways that drive inflammation. In COPD, the drug is intended to specifically address type 2 inflammation, an excessive immune response characterized by accumulation of certain immune cells in tissue. Dupixent’s FDA approval in COPD covers the drug’s use to treat patients whose disease is driven by immune cells called eosinophils. The FDA approval in COPD is based on results from two Phase 3 tests that compared the drug to a placebo in adults who were currently receiving standard-of-care inhaled therapy. Results for both studies showed statistically significant reductions in the annualized rate of moderate or severe COPD exacerbations measured over one year. Dupixent has been developed under a partnership between Sanofi and Regeneron, who share in profits from the drug. Sanofi recognizes all revenue from antibodies in the partnership. The drug accounted for €10.7 billion (about $11.6 billion) in sales in 2023, up nearly 30% from the prior year, according to the pharma giant’s annual report. Dupixent gives Sanofi a pipeline in a product opportunity, Paul Rowe, Sanofi’s head of medical affairs specialty care North America, said in an interview ahead of the FDA decision. The drug was first approved in 2017 for treating for atopic dermatitis followed by asthma in 2018. With the latest FDA nod, the drug can now treat six respiratory and dermatological conditions. “Given success we’ve had in these other disorders, we think there’s a strong rationale for COPD as well,” Rowe said. Sponsored Post Get Ready for HLTH 2024: A Preview Guide HLTH 2024, scheduled for October 20-23 at the Venetian Expo Center in Las Vegas, will highlight new programming, a physicians roundtable, generative AI, the shifting landscapes of telemedicine, retail health, women's health, and lots more. By Stephanie Baum COPD treatment has mainly consisted of older drugs, mostly inhaled therapies, but that’s changing. In June, the FDA approved Verona Pharma’s Ohtuvayre, an inhalable drug that hits two targets, one to counteract inflammation and the other to open up airways. Dupixent could also face new biologic competition. Nucala, a GSK antibody that blocks the IL-5 pathway, recently posted positive Phase 3 data in a COPD study. The results could represent a comeback for Nucala, which the FDA rejected for COPD in 2018. The injectable GSK drug is currently approved for treating asthma. An FDA decision for Dupixent in COPD was initially expected in June. But in May, the agency notified the company it needed more time to review additional clinical data it had requested. In a separate Friday decision, regulators in China approved Dupixent for COPD, Sanofi and Regeneron said. Dupixent’s first approval in COPD was in Europe, a regulatory decision handed out in July.