LAMA

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.

关注新药，直击前沿！ 今年6月全球首款PDE3/4双重抑制剂Ohtuvayre（ensifentrine）吸入用混悬液获得FDA批准，而且该项目在中国也正在进行Ⅲ期临床试验研究中，无疑让国内的follow者感到时间紧迫性。 近期，恒瑞的HRS-9821吸入混悬液和海思科的HSK39004吸入混悬液已快速推进到Ⅰ期临床试验中，加入到PDE3/4双重抑制剂竞争。 正大天晴的吸入用TQC3721混悬液是中国研发进度最快的国产PDE3/4双重抑制剂，已经完成Ⅰ期和Ⅱa期临床试验，并于9月7日至11日在奥地利维也纳举办的第34届欧洲呼吸学会国际大会（ERS International Congress 2024）以壁报形式入选。而在今年7月，吸入用TQC3721混悬液还在CDE药物临床试验登记与信息公示平台登记了第二项Ⅱ期临床试验（CTR20242692）。 此外，正大天晴还开发了TQC3721吸入粉雾剂，以提高未来临床患者用药便利性抢占更广泛市场。该项目也于9月9日获CDE临床试验默示许可。 PDE3/4抑制剂3大follow者正大天晴、恒瑞、海思科，正在对原研产品Ohtuvayre形成围攻之势。 有意思的是，ensifentrine化合物专利已过期，尽管Verona还布局多件制剂专利，如在国内：吸入液体制剂专利（CN106794157B及其分案申请CN111249260B）国内保护期到2035年，晶型专利（CN103313985B）保护期到2031年，此外，后续正在开发的ensifentrine干粉吸入制剂也申请了专利（CN114286672A实审中），如授权保护期将延至2040年。未来在国内是否会遭遇仿制药开发者专利无效挑战还有待遇观察。 Verona Pharma公司的PDE3/4双重抑制剂Ohtuvayre（ensifentrine）吸入用混悬液在今年6月获得FDA批准用于治疗慢性阻塞性肺病（COPD）之后，该公司并没有停止该项目的继续开发。 Ohtuvayre治疗非囊性纤维化支气管扩张、囊性纤维化和哮喘，以5与长效抗胆碱药物（LAMA）格隆溴铵固定剂量组合维持治疗COPD适应症的研究，都已经推进到Ⅱ期临床试验阶段。 更为重要的是，Verona Pharma开发的ensifentrine吸入粉雾剂(DPI)和定量吸入气雾剂(MDI)亦进入到Ⅱ期临床试验研究中。 尽管行业分析师认为Ohtuvayre将很快成为重磅炸弹级产品，如GlobalData预测该药到2029年销售额将达到10.5亿美元。Ohtuvayre在美国每月维持治疗费用为2950美元，年度成本为35400美元。 不过美国的临床医生对Ohtuvayre的应用却出现了分歧和质疑。 首先，Ohtuvayre每天通过雾化器给药两次，每次持续五到七分钟。用药的不便利可能会导致患者治疗依从性降低。Verona认为美国预计大约一半的COPD患者已经使用手持雾化设备，这种给药方式不会对该药物市场产生太大影响。但该公司继续开发ensifentrinedeDPI/MDI就已经很说明问题了。 其次，从临床研究看，Ohtuvayre更像是primary care，而非secondary care。Ohtuvayre的研究对象并不是病重患者，而是非标准护理人群。因此，研究中的很多患者本应接受三联疗法，但并没有，而是接受了单药治疗，并被随机分配继续接受新疗法或安慰剂治疗（在ENHANCE-1和-2研究中，三分之一的患者仅使用LAMA，16%的患者使用ICS/LABA双联吸入剂，没有患者使用三联吸入剂）。所以，把需要接受更高一级治疗的患者随机分配到新疗法Ohtuvayre与安慰剂中，取得积极的研究结果是肯定的，不过这也遭到医生质疑进行这种试验的道德性。没有将其作为已经使用三联疗法患者的附加疗法进行研究，没有将其作为正在使用LAMA/LABA且效果不佳的患者进行研究，是要添加ICS还是Ohtuvayre？因此，Ohtuvayre的临床试验是为了尽快通过监管终点线，而忽略了对临床医生来说非常重要的临床相关问题。 本文由「新药前沿」微信公众号根据公开资料整理编辑，欢迎个人转发至朋友圈。媒体或机构转载授权请在「新药前沿」微信公众号留言公众号名称，审核通过后开通白名单获取转载授权，转载请标识来源。 免责声明：本文仅作信息交流之目的，非投资建议或者治疗方案推荐，「新药前沿」微信公众号不对任何主体因使用本文内容而导致的任何损失承担责任。 限于作者水平和专业知识所限，如有谬误，欢迎指正！