Nuance Pharma Announces Ensifentrine Meets Primary Endpoint in Phase 3 ENHANCE-CHINA Trial for COPD
SHANGHAI, May 16, 2025 /PRNewswire/ -- Nuance Pharma ("Nuance") today announces its top-line Phase 3 ENHANCE-CHINA (NCT05743075) trial results evaluating nebulized ensifentrine for the maintenance treatment of chronic obstructive pulmonary disease ("COPD"). The ENHANCE-CHINA trial has successfully met its primary endpoint, as well as secondary endpoints demonstrating improvements in lung function.
The investigational study drug, ensifentrine is a first-in-class selective dual inhibitor of phosphodiesterase 3 and 4 ("PDE3; PDE4") that combines bronchodilator and non-steroidal anti-inflammatory effects in one molecule, delivered directly to the lungs through a standard jet nebulizer without the need for high inspiratory flow rates or complex hand-breath coordination.
Highlights
- Study population (n = 526 randomized):
Subject demographics and disease characteristics were well balanced between treatment groups
Approximately 46% of subjects received background COPD therapy, either a long-acting muscarinic antagonist ("LAMA") or a long-acting beta-agonist ("LABA"). Additionally, approximately 38% of all subjects received inhaled corticosteroids ("ICS") with concomitant LABA.
- Primary endpoint met (FEV1 AUC 0-12hr):
Placebo corrected, change from baseline in average FEV1 area under the curve 0-12 hours post dose at week 12 was 110 mL (p<0.0001) for ensifentrine
Statistically significant and clinically meaningful improvements with ensifentrine demonstrated across key subgroups including age, smoking status, COPD severity, background medication, ICS use, chronic bronchitis, FEV1 reversibility
- Secondary endpoints of lung function:
Placebo corrected, increase in peak FEV1 of 174 mL (p<0.0001) at week 12
Placebo corrected, increase in morning trough FEV1 of 36 ml (p=0.0533) and evening trough FEV1 of 65 ml (p=0.0038) at week 12, confirming twice daily dosing regimen.
Placebo corrected, increase in average FEV1 of 162 ml (p<0.0001) 0-4 hours post dose and 77 mL (p=0.0003) 6-12 hours post dose at week 12
- COPD symptoms and quality of life (QoL):
Clinically meaningful improvements in dyspnea as measured by Transition Dyspnea Index (TDI) in the ensifentrine group were observed at all weeks (6, 12 and 24) with a statistically significant improvement of 0.8 unit compared to placebo at week 24.
Quality of Life (QoL) as measured by St George's Respiratory Questionnaire (SGRQ) Total Score in the ensifentrine group improved from baseline to greater than the MCID of -4 units with a significant improvement of -2.9 units compared to placebo at week 24.
Daily symptoms as measured by Evaluating Respiratory Symptoms (E-RS) Total Score in ensifentrine group showed improvement from baseline as early as 6 weeks and continued improvement at 12 and 24 weeks, numerically exceeding placebo at each measurement.
- Exacerbation rate reduced
Subjects receiving ensifentrine demonstrated a 28% reduction in the rate of moderate/severe COPD exacerbations over 24 weeks compared to those receiving placebo (RR = 0.72, 95% CI: (0.43, 1.22))
Treatment with ensifentrine significantly decreased the risk of a moderate/severe exacerbation as measured by time to first exacerbation when compared with placebo by 25% (HR = 0.75, 95% CI: (0.44, 1.28))
- Favorable safety profile:
Ensifentrine was well-tolerated with treatment related AE incidence similar to placebo
Mark Lotter, founder and Chief Executive Officer of Nuance Pharma, said:"We are very pleased by the successful outcome of our Phase 3 ENHANCE-CHINA study, bringining us another step closer to providing a much needed novel therapy for COPD patients in China. These promising results demonstrate ensifentrine's strength as a first-in-class bronchodilator and non-steroidal anti-inflammatory therapy for COPD, as an advance to existing treatment options. We plan to submit a New Drug Application to the China NMPA in the second half of 2025. We would like to thank all the patients and investigators for their participation in the ENHANCE-CHINA program. "
Charlie Chen, Chief Operating Officer of Nuance Pharma added:"The totality of ENHANCE data including improvements in lung function, symptoms, quality of life measure and reduction in exacerbations, coupled with favorable safety profile, support our belief that ensifentrine will change the treatment paradigm for COPD. Following our ongoing early access programs in Hainan BoAo and Greater Bay Area, as well as regulatory approval in Macau, we look forward to bringing this medicine to patients in Greater China."
David Zaccardelli, Pharm. D., President and Chief Executive Officer of Verona Pharma, said:"we look forward to Nuance Pharma's continued progress and having Ohtuvayre® available for the millions of symptomatic patients needing additional treatment."
Nuance Pharma plans to release additional information from ENHANCE-CHINA at upcoming scientific conferences.
In Feb 2025, the Pharmaceutical Administration Bureau Macau approved Ohtuvayre™ (ensifentrine) for the maintenance treatment of COPD in adult patients. In Nov 2024, Nuance Pharma launched Ohtuvayre™ in China's Hainan Boao Pilot Zone through early access program. In Sep 2024, Nuance Pharma completed recruitment for ENHANCE-CHINA, the phase 3 clinical trial of Ohtuvayre™ (ensifentrine) for the maintenance treatment of COPD.
In June 2024, Nuance Pharma's global partner Verona Pharma plc (Nasdaq: VRNA), announced the US Food and Drug Administration ("FDA") approved Ohtuvayre™ (ensifentrine) for the maintenance treatment of COPD in adult patients.
In 2021, Nuance Pharma entered into an agreement with Verona Pharma for the exclusive rights to develop and commercialize Ohtuvayre™ (ensifentrine) in Greater China (mainland China, Hong Kong, Macau and Taiwan).
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.
About the ENHANCE-CHINA programThe randomized, double-blind, placebo-controlled study evaluate the efficacy and safety of nebulized ensifentrine as monotherapy and added onto a single bronchodilator, either a LAMA or a LABA, compared to placebo, and subjects may receive ICS.
Patient Population: 526 moderate to severe, symptomatic, COPD patients at 46 sites in China.
Dose/Duration: subjects were randomized to receive a 3mg nebulized dose of ensifentrine or nebulized placebo twice daily for 24 weeks
Primary Endpoint: Improvement in lung function with ensifentrine as measured by average FEV1 AUC 0-12 hours post dose at week 12.
Secondary Endpoints: lung function endpoints including peak and morning trough FEV1, COPD symptoms and health related quality of life through 24 weeks via SGRQ and E-RS, and exacerbation at 24 weeks, and others
Safety: Assessed over 24 weeks
Further information about ENHANCE-CHINA program can be found at www.clinicaltrials.gov (NCT05743075)
About Verona PharmaVerona 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. Ohtuvayre™ (ensifentrine) has potential applications in non-cystic fibrosis bronchiectasis, cystic fibrosis, asthma and other respiratory diseases. For more information, please visit www.veronapharma.com.
About Nuance PharmaNuance Pharma is an innovation focused biopharmaceutical company, with both late-stage clinical pipeline and commercial stage asset portfolio. Focusing on specialty care, Nuance has established a differentiated combination of commercialized assets and innovative pipeline across respiratory, pain management, emergency care and iron deficiency anemia. With the mission to address critical unmet medical needs in Asia Pacific, Nuance deploys the Dual Wheel model that develops a global leading innovative pipeline, while maintaining a self-sustainable commercial operation in both China and Asia as a region. For more information, please visit www.nuancepharma.com.
Forward-looking StatementsThis news release may make statements that constitute forward-looking statements, including descriptions regarding the intent, belief or current expectations of the Company or its officers with respect to the business operations and financial condition of the Company, which can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," "confident" and similar statements. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the control of the Company and are unforeseeable. Therefore, the actual results may differ from those in the forward-looking statements as a result of various factors and assumptions, such as future changes and developments in our business, competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives has no obligation and does not undertake to revise forward-looking statements to reflect new information, future events or circumstances after the date of this news release, except as required by law.
View original content:https://www.prnewswire.com/apac/news-releases/nuance-pharma-announces-ensifentrine-meets-primary-endpoint-in-phase-3-enhance-china-trial-for-copd-302457563.html
SOURCE Nuance Pharma Limited
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
an hour ago
- Yahoo
Asian Market Insights: 3 Stocks That Investors Might Be Undervaluing
As global markets respond to easing trade tensions and positive economic signals, Asian indices have shown resilience, with notable gains in China and Japan. In this environment, identifying undervalued stocks becomes crucial for investors seeking opportunities amidst the broader market optimism. Name Current Price Fair Value (Est) Discount (Est) T'Way Air (KOSE:A091810) ₩2025.00 ₩4024.62 49.7% Suzhou Zelgen BiopharmaceuticalsLtd (SHSE:688266) CN¥111.64 CN¥222.46 49.8% SIGMAXYZ Holdings (TSE:6088) ¥1221.00 ¥2440.83 50% Shanghai OPM Biosciences (SHSE:688293) CN¥43.21 CN¥85.97 49.7% Prospect Logistics and Industrial Freehold and Leasehold Real Estate Investment Trust (SET:PROSPECT) THB7.20 THB14.35 49.8% Maxscend Microelectronics (SZSE:300782) CN¥69.87 CN¥139.59 49.9% KeePer Technical Laboratory (TSE:6036) ¥3375.00 ¥6748.76 50% Good Will Instrument (TWSE:2423) NT$43.40 NT$86.69 49.9% Forum Engineering (TSE:7088) ¥1195.00 ¥2373.59 49.7% Duk San NeoluxLtd (KOSDAQ:A213420) ₩33600.00 ₩66906.69 49.8% Click here to see the full list of 268 stocks from our Undervalued Asian Stocks Based On Cash Flows screener. Let's review some notable picks from our screened stocks. Overview: Genscript Biotech Corporation is an investment holding company involved in the manufacture and sale of life science research products and services across the United States, Europe, Mainland China, Asia Pacific, and internationally, with a market cap of HK$33.16 billion. Operations: The company's revenue is primarily derived from Life Science Services and Products ($454.95 million), Biologics Development Services ($95.02 million), and Industrial Synthetic Biology Products ($53.69 million). Estimated Discount To Fair Value: 31.1% Genscript Biotech is trading at HK$15.22, significantly below its estimated fair value of HK$22.09, suggesting it may be undervalued based on cash flows. Recent payments totaling US$213.8 million from ProBio bolster its cash reserves, enhancing financial stability and core competencies. While earnings are forecast to grow substantially at 65.8% per year and revenue growth outpaces the Hong Kong market, a low return on equity of 7.1% in three years presents a potential concern for investors seeking high returns. Our expertly prepared growth report on Genscript Biotech implies its future financial outlook may be stronger than recent results. Dive into the specifics of Genscript Biotech here with our thorough financial health report. Overview: Suzhou Nanomicro Technology Co., Ltd. manufactures and supplies spherical, mono-disperse particles for various industries worldwide, with a market cap of CN¥9.13 billion. Operations: The company's revenue segments include the production and distribution of spherical, mono-disperse particles for diverse industrial applications globally. Estimated Discount To Fair Value: 15.5% Suzhou Nanomicro Technology is trading at CN¥22.77, below its estimated fair value of CN¥26.96, indicating potential undervaluation based on cash flows. Earnings are expected to grow significantly at 37.9% per year, outpacing the broader Chinese market's growth rate. Recent financial results show revenue increased to CN¥188.59 million from CN¥154.1 million a year ago, with net income rising to CN¥29.22 million from CN¥16.89 million, supporting its growth trajectory despite a forecasted low return on equity of 11%. The analysis detailed in our Suzhou Nanomicro Technology growth report hints at robust future financial performance. Click here and access our complete balance sheet health report to understand the dynamics of Suzhou Nanomicro Technology. Overview: SBS Holdings, Inc. offers logistics services both in Japan and internationally, with a market cap of ¥126.90 billion. Operations: The company generates revenue from its Logistics Business, which accounts for ¥429.82 billion, and its Real Estate Business, contributing ¥10.09 billion. Estimated Discount To Fair Value: 35.5% SBS Holdings, trading at ¥3195, is significantly undervalued with a fair value estimate of ¥4956.46 according to discounted cash flow analysis. Despite profit margins declining from 1.9% to 1.3%, earnings are projected to grow at 22.44% annually, surpassing the Japanese market growth rate of 7.5%. However, the dividend yield of 2.66% isn't well covered by free cash flows and debt coverage by operating cash flow remains weak amidst planned strategic acquisitions like Bridgestone Logistics Co., Ltd.'s stock. In light of our recent growth report, it seems possible that SBS Holdings' financial performance will exceed current levels. Click here to discover the nuances of SBS Holdings with our detailed financial health report. Unlock our comprehensive list of 268 Undervalued Asian Stocks Based On Cash Flows by clicking here. Already own these companies? Bring clarity to your investment decisions by linking up your portfolio with Simply Wall St, where you can monitor all the vital signs of your stocks effortlessly. Invest smarter with the free Simply Wall St app providing detailed insights into every stock market around the globe. Explore high-performing small cap companies that haven't yet garnered significant analyst attention. Diversify your portfolio with solid dividend payers offering reliable income streams to weather potential market turbulence. Fuel your portfolio with companies showing strong growth potential, backed by optimistic outlooks both from analysts and management. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include SEHK:1548 SHSE:688690 and TSE:2384. This article was originally published by Simply Wall St. Have feedback on this article? Concerned about the content? with us directly. Alternatively, email editorial-team@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Health Line
2 hours ago
- Health Line
The Four Stages of Chronic Obstructive Pulmonary Disease (COPD)
Key takeaways COPD is a progressive lung disease with mild symptoms in the early stages that gradually worsen. Early diagnosis and treatment can help preserve lung function. The GOLD system previously classified COPD from stages 1 to 4 based on lung capacity as measured by a spirometry test. New guidelines now combine spirometry results with symptom severity to assess risk and determine staging. Quitting smoking and avoiding secondhand smoke after receiving a diagnosis of COPD can improve your life expectancy and outlook. People with COPD often have trouble breathing, a persistent cough, and shortness of breath. COPD can be subdivided into stages or grades, depending on how far it has progressed. It is most common in smokers and people over the age of 40. Keep reading to learn about the four stages of COPD. We'll discuss the symptoms you can expect at each stage and potential treatment options. What is the GOLD system for categorizing COPD severity? The Global Initiative for Chronic Obstructive Lung Disease (GOLD) is a program started by the National Heart, Lung, and Blood Institute (NHLBI) and the World Health Organization (WHO). Countries around the world use its guidelines and recommendations for diagnosing and treating COPD. The GOLD system previously classified COPD from stages 1 to 4 solely based on your lung capacity measured by a spirometry test. But the newest GOLD guidelines combine your spirometry results with subjective measures of your symptom severity to determine your level of risk based on their ABCD rubric. A spirometer test involves exhaling into a machine called a spirometer. The machine measures how hard and quickly you can exhale. Your doctor examines two numbers in your results: your force vital capacity (FVC) and your force expiratory volume in one second (FEV1). Your FVC is the total amount of air you can breathe out and FEV1 is the amount you breathe out in one second. A ratio of your FEV1/FVC needs to be less than 0.7 for a diagnosis of COPD. Doctors grade your spirometry results from grade 1 (least severe) to grade 4 (most severe). In the old system, these grades correlate with stage 1 to stage 4 COPD. Doctors determine the severity of your symptoms using either the British Medical Research Council (mMRC) questionnaire or the COPD Assessment Test (CAT). Stage 1: Early Stage 1 COPD is considered mild. At this stage, you may not be aware that you have anything wrong with your lung function. A doctor assigns you with grade 1 COPD if your FEV1 is between 80 and 100% of your predicted value. Symptoms If you score grade 1 on your spirometry test, you may not have any noticeable symptoms. If you do have symptoms, you may develop a cough and increased mucus production. You may mistake the early stages of COPD for the flu. Treatment With stage 1 COPD, your doctor may recommend a bronchodilator medication to open up the airways in your lungs. These medications are usually taken through an inhaler or nebulizer. Your doctor may also recommend getting flu, COVID-19, and pneumonia vaccines to prevent illnesses that may worsen your respiratory symptoms. Changing lifestyle habits that led to the development of COPD can potentially help slow the progression of your COPD. Most people with COPD have a history of smoking. Quitting smoking and avoiding secondhand smoke are two of the most important things you can do to improve your outlook with COPD. Stage 2: Mild Your COPD is considered to be stage 2 when your FEV1 drops to 50 to 79% of your predicted value. Symptoms During stage 2, your symptoms worsen from stage 1. Your coughing and mucus production may become more severe, and you may experience shortness of breath when walking or exercising. Typically, it's in this stage that people realize that something is wrong and seek medical attention from a doctor. Treatment You may be given bronchodilator medication to increase airflow to your lungs. Your doctor may recommend pulmonary rehabilitation, a program designed to increase your awareness about your condition. It's usually offered as a group class where you learn how to manage your condition better. If you have a flare-up of symptoms, you may need to take steroids or oxygen. Stage 3: Severe By the time you reach stage 3, COPD is considered severe, and your forced expiratory volume is between 30 to 50 percent of your predicted value. You may have trouble catching your breath doing household chores and may not be able to leave your house. Symptoms By stage 3, you may get more frequent flare-ups, and your shortness of breath and coughing typically get worse. You will likely find you get tired easier than before. Other potential symptoms can include: Treatment The treatment options for stage 3 COPD are similar to stage 2. You're more likely to need oxygen therapy at this stage. Stage 4: Very severe Stage 4 is considered very severe. Your forced expiratory volume is less than 30% of your normal value, and your blood oxygen levels are also low. You're at risk of developing COPD complications like heart or lung failure. Symptoms By stage 4, you'll likely have frequent flare-ups that can be potentially fatal. You may have trouble breathing even when you're resting. Treatment Treatment options during stage 4 are similar to the previous stages. Your doctor may also recommend lung surgery to improve breathing. Surgical options include: lung transplant lung volume reduction surgery bullectomy Is there an end stage to COPD? A grade 4 score on your spirometry test is the highest grade you can receive. This category is also sometimes referred to as end stage COPD. For many people at this stage, quality of life is usually fairly low, and symptom flare-ups can be fatal. What is the life expectancy of someone with COPD? Having COPD lowers your life expectancy. However, the amount that it affects your life expectancy depends on many factors, such as how far your COPD has progressed and whether you quit smoking or change the other lifestyle habits that lead to COPD. An older 2009 study found that COPD led to a small reduction in life span for people who have never smoked, but a larger life span decrease for people who currently smoke or smoked in the past. According to the researchers, a 65-year-old man who smokes would lose 3.5 years from their life expectancy for smoking, plus the following values for having COPD: Stage 1: 0.3 years Stage 2: 2.2 years Stage 3 or 4: 5.8 years For former smokers, the reductions are: Stage 1: 1.4 years Stage 2, 3, or 4: 5.6 years For somebody who never smoked, the reductions are: Stage 2: 0.7 years Stage 3 or 4: 1.3 years In a 2017 study, researchers followed a group of long-term smokers with COPD for 5 years. They found that participants who had died before a 5-year follow-up had a longer average smoking time and a lower prevalence of quitting smoking. The researchers concluded that smoking time may be related to COPD mortality rate, and quitting smoking has the largest potential to influence COPD outlook. A 2020 study of 532 people with COPD at a hospital in Taiwan suggests that loss of life years can vary based on a person's GOLD stage: GOLD stage 1: no reduction GOLD stage 2: 6.2 years GOLD stage 3: 9.3 years GOLD stage 4: 9.4 years This study did not distinguish by smoking history. Can you prevent COPD from progressing? COPD can't be reversed, and it's currently not possible to stop the progression of your COPD completely. You can help slow the progression of COPD as much as possible by working with your doctor and following a proper treatment program. Living with COPD No matter how far your COPD has progressed, it's important to change the lifestyle habits that caused your COPD in the first place. The most important thing you can do is quit smoking. If you don't quit, you'll continue to damage your lungs, and your COPD will progress quicker than it would otherwise. Eating a nutrient-rich eating plan filled with plenty of vegetables, healthy fats, protein, and unprocessed foods may help you manage your symptoms and maintain a healthy weight. Eating foods that cause bloating, like apricots or peaches, may worsen breathing problems in some people. Regular exercise may help decrease symptoms of COPD by strengthening your respiratory muscles and improving your cardiovascular health. Your doctor may be able to suggest exercise that is safe for you.
Yahoo
2 hours ago
- Yahoo
Apollo Hospitals MD on Growth Outlook, Healthtech Arm Spinoff
Apollo Hospitals Managing Director, Suneeta Reddy, says she expects to see 14% growth in company revenue in the next three years. On Bloomberg's Insight with Haslinda Amin, she also told us exclusively about prospects for their planned healthtech arm spinoff.
