A Phase I, Open-Label, Single and Multiple Dose (Twice-Daily), Clinical Trial to Evaluate the Pharmacokinetics, Safety and Tolerability of Aclidinium Bromide 400 μg Administered by Inhalation in Healthy Chinese Participants

A Phase I, single centre, open-label study to investigate the pharmacokinetics (PK), safety and tolerability of single and multiple twice daily doses of inhaled Aclidinium Bromide in healthy Chinese male and female subjects.

Start Date14 Oct 2021

Sponsor / Collaborator

AstraZeneca PLC

CTR20212507 / CompletedPhase 1

评估阿地溴铵 400 μg 吸入给药在健康中国参与者中的药代动力学特性、安全性和耐受性的一项 I 期、开放性标签、单剂和多剂（每日两次）临床试验

[Translation] A Phase I, open-label, single- and multiple-dose (twice daily) clinical trial to evaluate the pharmacokinetic properties, safety, and tolerability of aclidinium bromide 400 μg by inhalation in healthy Chinese participants

主要目的是评估阿地溴铵 400 μg 制剂在中国健康志愿者中单剂给药和多剂（每日二次）给药后，阿地溴铵及其代谢物的药代动力学（PK）特性。次要目的是评估阿地溴铵 400 μg 制剂单剂给药和多剂（每日二次）给药在健康中国参与者中的安全性和耐受性。

[Translation]

The primary objective was to evaluate the pharmacokinetic (PK) properties of aclidinium bromide and its metabolites after single and multiple (twice daily) doses of aclidinium bromide 400 μg formulation in healthy Chinese volunteers. The secondary objective was to evaluate the safety and tolerability of aclidinium bromide 400 μg formulation in healthy Chinese participants after single and multiple (twice daily) doses.

Start Date14 Oct 2021

Sponsor / Collaborator

AstraZeneca AB

[+2]

NCT03290287 / CompletedNot Applicable

Aclidinium Bromide Post-Authorisation Safety Study to Evaluate the Risk of Cardiovascular Endpoints: Common Study Protocol

The purpose of this study is to evaluate the potential cardiovascular safety concerns and all-cause mortality described in the risk management plan for aclidinium bromide, through sequential, nested case-control studies for each endpoint of interest

Start Date01 Mar 2017

Sponsor / Collaborator

AstraZeneca PLC

[+1]

100 Clinical Results associated with Aclidinium Bromide

100 Translational Medicine associated with Aclidinium Bromide

100 Patents (Medical) associated with Aclidinium Bromide

221

Literatures (Medical) associated with Aclidinium Bromide

01 Jan 2024·Drug safety

Chronic Obstructive Pulmonary Disease Adverse Event Signals Associated with Potential Inhibitors of Glutathione Peroxidase 1: A Sequence Symmetry Analysis

Article

Author: Pratt, Nicole L ; Janetzki, Jack L ; Ward, Michael B ; Sykes, Matthew J

BACKGROUND AND OBJECTIVE:

Prior molecular modelling analysis identified several medicines as potential inhibitors of glutathione peroxidase 1 (GPx1) which may contribute to development or progression of chronic obstructive pulmonary disease (COPD). This study investigates 40 medicines (index medicines) for signals of COPD development or progression in a real-world dataset.

METHODS:

Sequence symmetry analysis (SSA) was conducted using a 10% extract of Australian Pharmaceutical Benefits Scheme (PBS) claims data between January 2013 and September 2019. Patients must have been initiated on an index medicine and a medicine for COPD development or progression within 12 months of each other. Sequence ratios were calculated as the number of patients who initiated an index medicine followed by a medicine for COPD development or progression divided by the number who initiated the index medicine second. An adjusted sequence ratio (aSR) was calculated which accounted for changes in prescribing trends. Adverse drug event signals (ADEs) were identified where the aSR lower 95% confidence interval (CI) was greater than 1.

RESULTS:

Twenty-one of 40 (53%) index medicines had at least one ADE signal of COPD development or progression. Signals of COPD development, as identified using initiation of tiotropium, were observed for atenolol (aSR 1.32, 95% CI 1.23-1.42) and naproxen (aSR 1.14, 95% CI 1.06-1.23). Several signals of COPD progression were observed, including initiation of fluticasone propionate/salmeterol following initiation of atenolol (aSR 1.44, 95% CI 1.30-1.60) and initiation of aclidinium/formoterol following initiation of naproxen (aSR 2.21, 95% CI 1.34-3.65).

CONCLUSION:

ADE signals were generated for several potential GPx1 inhibitors; however, further validation of signals is required in large well-controlled observational studies.

01 Jan 2024·Journal of pharmaceutical and biomedical analysis

Investigation of aclidinium bromide degradation by stability-indicating HPLC methods, characterization of impurities by NMR, and identification of degradation products by LC-MS

Article

Author: Narin, İbrahim ; Yılmaz, Erkan ; Aydın Özel, Fatma Gözde ; Bellur Atici, Esen ; Yazar, Yücel

Aclidinium bromide (ACL) is a long-acting muscarinic receptor antagonist used for the long-term treatment of chronic obstructive pulmonary disease (COPD). The aim of this study was to investigate the degradation of aclidinium bromide under stress and stability testing conditions, for which we developed and validated the first stability-indicating, specific, precise, accurate, and robust assay and related substances HPLC methods. Nine of the compounds used as reference standards were synthesized and fully characterized by ¹H and ¹³C NMR, MS, and FTIR techniques. Two of these molecules, namely ACL-dimer and ACL-desphenyl, are novel compounds and reported herein for the first time. Hydrolysis of aclidinium resulted in major degradation via the formation of ACL-desDTG and DTGA metabolites. ACL-desphenyl and phenol were observed only under oxidative conditions at very low levels (< 0.10%), while ACL-hydroxy, known as a metabolite of aclidinium and confirmed by LC/QDa and LC/Q-TOF m/z data, formed under oxidative stress-testing conditions, UV light, and daylight. The identification of two impurities formed only when aclidinium bromide was treated with hydrogen peroxide was done by LC/QDa and LC/Q-TOF studies and the novel structures were proposed as ACL-bromophenoxy and ACL-bromothiophenyl formed via bromination of the phenyl and thiophene ring on the aclidinium, respectively. The stress and photostability testing studies showed that the aclidinium bromide drug substance is not sensitive to elevated temperature (105 °C, 10 days), slightly sensitive to daylight and UV-radiation, and it showed significant degradation under all hydrolysis and oxidizing conditions. The related substances HPLC method reported herein is also capable to monitor the potential genotoxic impurity 3-bromopropoxybenzene (3-BPB), a class 2 impurity according to ICH M7, and ensures that the impurity remains below the threshold of toxicological concern (TTC) limit, making it safe for patients.

01 Dec 2023·International journal of pharmaceutics: X

The effect of lung emptying before the inhalation of aerosol drugs on drug deposition in the respiratory system

Article

Author: Kugler, Szilvia ; Farkas, Árpád ; Tomisa, Gábor ; Szénási, Georgina ; Nagy, Attila ; Füri, Péter ; Varga, János ; Horváth, Alpár

The amount of drug depositing in the airways depends, among others, on the inhalation manoeuvre and breathing parameters. The objective of this study was to quantify the effect of lung emptying before the inhalation of drugs on the lung doses. Thirty healthy adults were recruited. Their breathing profiles were recorded while inhaling through six different emptied DPI devices without breathe-out and after comfortable or forced exhalation. The corresponding emitted doses and aerosol size distributions were derived from the literature. The Stochastic Lung Model was used to estimate the deposited doses. In general, forceful exhalation caused increased flow rate and inhaled air volume. Increased flow rate led to the increase of the average lung dose for drugs with positive lung dose-flow rate correlation (e.g. Symbicort®: relative increase of 6.7%, Bufomix®: relative increase of 9.2%). For drugs with negative correlation of lung dose with flow rate (all the studied drugs except the above two) lung emptying caused increased (Foster® by 2.7%), almost unchanged (Seebri®, Relvar®, Bretaris®) and also decreased (Onbrez® by 6.6%) average lung dose. It is worth noting that there were significant inter-individual differences, and lung dose of each drug could be increased by a number of subjects. In conclusion, the change of lung dose depends on the degree of lung emptying, but it is also inhaler and drug specific. Forceful exhalation can help in increasing the lung dose only if the above specificities are taken into account.

News (Medical) associated with Aclidinium Bromide

05 Jan 2024

·www.prnewswire.com

Theravance Biopharma Announces Results from the Phase 4 YUPELRI® PIFR-2 Study in Patients with Severe to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

DUBLIN, Jan. 5, 2024 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ: TBPH) today announced results from the Phase 4 PIFR-2 study of YUPELRI® (revefenacin) inhalation solution, the only once-daily, nebulized long-acting muscarinic antagonist (LAMA) approved in the U.S. for maintenance treatment of COPD. The PIFR-2 study aimed to demonstrate greater improvement in lung function for YUPELRI delivered via standard jet nebulizer compared to Spiriva® (tiotropium) delivered via a dry powder inhaler (Spiriva® HandiHaler®) in adults with severe to very severe COPD and suboptimal peak inspiratory flow rate (PIFR). The study did not show a statistically significant difference between YUPELRI and Spiriva HandiHaler on the primary endpoint, change from baseline in trough forced expiratory volume in one second (FEV1) at Day 85. Similar lung function improvement was demonstrated in both arms of the study. YUPELRI demonstrated safety and tolerability consistent with its profile in previous clinical studies. Chief Executive Officer Rick E Winningham said: "While the primary endpoint in the Phase 4 PIFR-2 study was not met, YUPELRI demonstrated an efficacy and safety profile consistent with its performance in other clinical studies. We appreciate the growth opportunities that lie ahead for YUPELRI, which is an important option for COPD maintenance care, and look forward to sharing additional details from PIFR-2 in the future, following additional data analyses." About the PIFR-2 Study The Phase 4 PIFR-2 Study (NCT05165485) is a randomized, double-blind, parallel-group study, comparing improvements in lung function in adults with severe to very severe COPD (FEV1 <50% of predicted) and suboptimal PIFR (<55 L/min) following once-daily treatment over 12 weeks with either YUPELRI (revefenacin) inhalation solution delivered via standard jet nebulizer or Spiriva (tiotropium) delivered via a dry powder inhaler (Spiriva HandiHaler). YUPELRI is approved in the U.S. for the maintenance treatment of patients with COPD; Spiriva HandiHaler is approved in the U.S. for the long-term, once-daily, maintenance treatment of bronchospasm associated with COPD, and for reducing COPD exacerbations. About YUPELRI® YUPELRI® (revefenacin) inhalation solution is a once-daily nebulized long-acting muscarinic antagonist (LAMA) approved for the maintenance treatment of COPD in the U.S. LAMAs are recognized by international COPD treatment guidelines as a cornerstone of maintenance therapy for COPD, regardless of severity of disease. Our market research indicates there is an enduring population of COPD patients in the U.S. that either need or prefer nebulized delivery for maintenance therapy. The stability of revefenacin in both metered dose inhaler and dry powder inhaler ("MDI/DPI") formulations suggests that revefenacin could also serve as a foundation for novel handheld combination products. Important Safety Information What is YUPELRI®? YUPELRI is a prescription medicine used to treat chronic obstructive pulmonary disease (COPD), a long-term (chronic) lung disease that includes chronic bronchitis, emphysema, or both. It is an anticholinergic medicine which helps the muscles around the airway in your lungs stay relaxed to prevent symptoms such as wheezing, cough, chest tightness, and shortness of breath. It is used long-term as 1 vial of YUPELRI, 1 time each day inhaled through your nebulizer to improve symptoms of COPD for better breathing. Who should not use YUPELRI? Do not use YUPELRI if you have sudden breathing problems. Always have a rescue inhaler with you. Do not use YUPELRI if you have had an allergic reaction to revefenacin, or any of the other ingredients in YUPELRI (sodium chloride, citric acid, sodium citrate). Do not use in children. It is not known if YUPELRI is safe and effective in children. Before using YUPELRI, tell your healthcare provider about all your medical conditions, including if you: have eye problems such as glaucoma. YUPELRI may make your glaucoma worse. have prostate or bladder problems, or problems passing urine. YUPELRI may make these problems worse. have liver problems. are allergic to any of the ingredients in YUPELRI, or any other medicines. are pregnant or planning to become pregnant. It is not known if YUPELRI may harm your unborn baby. are breastfeeding. It is not known if the medicine in YUPELRI passes into your breast milk and if it can harm your baby. Tell your healthcare provider about all the medicines you take including prescription and over-the-counter medicines, vitamins, and herbal supplements. YUPELRI and certain other medicines may interact with each other. This may cause serious side effects. Especially tell your healthcare provider if you take: Other anticholinergics (including tiotropium, ipratropium, aclidinium, umeclidinium, glycopyrrolate) Atropine Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine. What are the possible side effects with YUPELRI? YUPELRI can cause serious side effects, including: Sudden breathing problems immediately after inhaling your medicine. If you have sudden breathing problems immediately after inhaling your medicine, stop using YUPELRI and call your healthcare provider right away. New or worsened eye problems including acute narrow-angle glaucoma. Acute narrow-angle glaucoma can cause permanent loss of vision if not treated. Symptoms may include: Red eyes Blurred vision Seeing halos or bright colors around lights Eye pain or discomfort Nausea or vomiting Urinary retention. People who take YUPELRI may develop new or worse urinary retention. Symptoms of urinary retention may include: difficulty urinating urinating frequently urination in a weak stream or drips painful urination If you have any of these symptoms, call your healthcare provider right away before taking another dose. Serious allergic reactions. Call your healthcare provider or get emergency medical care if you get any of the following symptoms of a serious allergic reaction: rash hives severe itching swelling of your face, mouth, and tongue difficulty breathing or swallowing If you have any of these symptoms, stop taking YUPELRI, and call your healthcare provider right away before taking another dose. Common side effects of YUPELRI include: Cough Runny nose Upper respiratory tract infection Headache Back pain Tell your healthcare provider if you get any side effects that bother you or that do not go away. These are not all the possible side effects with YUPELRI. Ask your healthcare provider or pharmacist for more information. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I use YUPELRI? Read the step by step instructions for using YUPELRI in the FDA-approved Prescribing Information and at the end of this Patient Information Leaflet YUPELRI is only for use with a nebulizer. Do not use YUPELRI more often than prescribed. Do not mix YUPELRI with other medicines in your nebulizer. Do not use other medicines that contain an anticholinergic for any reason. Do not stop using YUPELRI, even if you are feeling better, unless your healthcare provider tells you to because your symptoms might get worse. Call your healthcare provider or get emergency medical care right away if your breathing problems get worse. you need to use your rescue inhaler medicine more often than usual. your rescue inhaler medicine does not relieve your symptoms. This summary does not include all the information about YUPELRI and is not meant to take the place of a discussion with your healthcare provider about your treatment. About Theravance Biopharma Theravance Biopharma, Inc.'s focus is to deliver Medicines that Make a Difference® in people's lives. In pursuit of its purpose, Theravance Biopharma leverages decades of expertise, which has led to the development of FDA-approved YUPELRI® (revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Ampreloxetine, its late-stage investigational norepinephrine reuptake inhibitor in development for symptomatic neurogenic orthostatic hypotension, has the potential to be a first in class therapy effective in treating a constellation of cardinal symptoms in multiple system atrophy patients. The Company is committed to creating/driving shareholder value. For more information, please visit . THERAVANCE BIOPHARMA®, THERAVANCE®, and the Cross/Star logo are registered trademarks of the Theravance Biopharma group of companies (in the U.S. and certain other countries). YUPELRI® is a registered trademark of Mylan Specialty L.P., a Viatris company. Trademarks, trade names or service marks of other companies appearing on this press release are the property of their respective owners. About Theravance Biopharma / Viatris Collaboration Theravance Biopharma and Viatris Inc. and their respective affiliates have established a strategic collaboration to develop and commercialize nebulized revefenacin products for COPD. Theravance Biopharma Forward-Looking Statements This press release contains certain "forward-looking" statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives, expectations and future events. Theravance Biopharma intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. Examples of such statements include statements relating to: future YUPELRI sales and sales growth, timing of additional details from PIFR-2, and the ability to provide value to shareholders, the Company's regulatory strategies and timing of clinical studies, and possible safety, efficacy or differentiation of our investigational therapy. These statements are based on the current estimates and assumptions of the management of Theravance Biopharma as of the date of this press release and are subject to risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Theravance Biopharma to be materially different from those reflected in the forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to: whether the milestone thresholds can be achieved, delays or difficulties in commencing, enrolling or completing clinical studies, the potential that results from clinical or non-clinical studies indicate the Company's product candidates or product are unsafe, ineffective or not differentiated, risks of decisions from regulatory authorities that are unfavorable to the Company, dependence on third parties to conduct clinical studies, delays or failure to achieve and maintain regulatory approvals for product candidates, risks of collaborating with or relying on third parties to discover, develop, manufacture and commercialize products, and risks associated with establishing and maintaining sales, marketing and distribution capabilities with appropriate technical expertise and supporting infrastructure, ability to retain key personnel, the ability of the Company to protect and to enforce its intellectual property rights, volatility and fluctuations in the trading price and volume of the Company's shares, and general economic and market conditions. Other risks affecting Theravance Biopharma are in the Company's Form 10-Q filed with the SEC on November 9, 2023, and other periodic reports filed with the SEC. In addition to the risks described above and in Theravance Biopharma's filings with the SEC, other unknown or unpredictable factors also could affect Theravance Biopharma's results. No forward-looking statements can be guaranteed, and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Theravance Biopharma assumes no obligation to update its forward-looking statements on account of new information, future events or otherwise, except as required by law. Theravance Biopharma Contact: [email protected] 650-808-4045 SOURCE Theravance Biopharma, Inc.

Clinical ResultDrug ApprovalPhase 3

25 Jan 2023

·www.prnewswire.com

The Worldwide Chronic Obstructive Pulmonary Disease (COPD) Industry is Expected to Reach $22.9 Billion by 2028

DUBLIN, Jan. 25, 2023 /PRNewswire/ -- The "Chronic Obstructive Pulmonary Disease (COPD) Market, Global Forecast 2023-2028, Industry Trends, Growth, Insight, Impact of Inflation, Company Analysis" report has been added to ResearchAndMarkets.com's offering. The Global Chronic Obstructive Pulmonary Disease (COPD) Market will increase to around USD 22.91 Billion by 2028 according to the publisher. Chronic inflammatory lung disease causes breathing difficulties. It is a group of progressive lung diseases. The most common diseases are emphysema and chronic bronchitis. COPD, if left untreated, can lead to worsening respiratory infection, heart problems, and the progression of various other diseases. COPD is commonly caused due to smoking tobacco-related products. The longer and more tobacco products an individual smokes, the greater risk of having COPD. Cigarette smoking, cigar smoke, pipe smoke, and second-hand smoke can also cause COPD. According to World Health Organization (WHO), COPD is considered the third leading cause of death worldwide, and nearly 90% of Global Chronic Obstructive Pulmonary Disease deaths in those under 70 years of age occur in low and medium income countries (LMIC). Worldwide Chronic Obstructive Pulmonary Disease Market will grow at a CAGR of 5.73% from 2022 to 2028 The rise in the incidence of COPD is the major contributor to the market's growth. In addition, people's lifestyle change is responsible for increasing habits like smoking and drinking. The other factors that influence the growth of the COPD market are a rise in demand for medications for the treatment of COPD symptoms, an increase in funding for R&D and drug production by government and pharmaceutical companies, growing awareness among people across developing and underdeveloped countries, are boosting the growth of the market companies. Nevertheless, the high cost of COPD treatment and lack of knowledge about COPD is anticipated to hinder the market's growth. Also, factors like patent expiry for medical devices will restrict the development of the market. Chronic Bronchitis will lead in Chronic Obstructive Pulmonary Disease Market Based on type, the global COPD market is categorized into; chronic bronchitis and emphysema. The chronic bronchitis category dominates the market share of the worldwide COPD market. The reason for its dominance is the growing incidence and prevalence of chronic bronchitis worldwide, due to the rise in the consumption of cigarettes and the increase in industrialization, which results in air pollution and the release of harmful gases into the environment. Drug remain the most important segment in Treatment Type Based on treatment, the global COPD market is divided into; drugs, oxygen therapy, surgery, and others. The drugs segment has a higher market share in the market, owing to the increasing use of drugs as the first line of treatment for COPD to make breathing easier by widening airways. The oxygen therapy market is also expected to surge at a significant CAGR rate in the forecast period. The growth can be attributed to factors like the rapid growth of the geriatric population, the rising prevalence of tobacco smoking, the development of respiratory disorders, the increase in the usage of home-based oxygen therapy, and technological advancements. Rise in Number of COPD Therapeutics Dispensed to boost the hospital Segment The distribution channels can be segmented into; hospital pharmacies, retail pharmacies, and online pharmacies. The hospital pharmacies segment has a high market share. The dominance due to the rising number of patients suffering from chronic respiratory diseases and rising awareness about these diseases. Furthermore, the availability of various diagnostics and treatment facilities and higher purchasing power has contributed to the segment's growth. North American area dominates the COPD Industry The report divides the region into; North America, Europe, Asia-Pacific, Latin America, and Middle-East & Africa. The North American area dominates the market share. This can be attributed to increased investment in R&D activities to develop innovative drugs for treating diseases. Also, the rise in an older population, rising incidence and prevalence of chronic respiratory diseases, technological advancement, growing healthcare sectors, and massive presence of leading market players are some of the major factors that boost the COPD Market in the region. The Asia-Pacific region is forecasted to have significant growth, owing to increasing focus on the development of healthcare infrastructure, rising prevalence of various chronic respiratory diseases along with lifestyle diseases, rise in industrialization, changes in the lifestyle, and increase in the patient population suffering from COPD in the developing nations such as China, and India. According to our research report, Worldwide Chronic Obstructive Pulmonary Disease (COPD) Market was at US$ 16.40 Billion in 2022. Key Players in Chronic Obstructive Pulmonary Disease Market COPD market is consolidated with the presence of a small number of key players. Also, the key players are constantly involved in product innovation and development, technological advancements, agreements, mergers, and acquisitions to procure a higher market share. The key players in the market are; AstraZeneca, Pfizer Inc., GlaxoSmithKline Plc, Novartis AG, Astellas Pharma, Abbott Laboratories, Boehringer Ingelheim International GmbH, and Almirall. For instance, In Nov 2021, AstraZeneca announced that sold rights to sell Tudorza, also known as Eklira abroad, and Duaklir to the Switzerland-based pharmaceutical company CovisPharma Group for US$ 270 Mn. These products are indicated for treating chronic obstructive pulmonary disease (COPD). Key Topics Covered: 1. Introduction 2. Research & Methodology 3. Executive Summary 4. Market Dynamics 4.1 Growth Drivers 4.2 Challenges 5. Global Chronic Obstructive Pulmonary Disease Copd Market 6. Market Share - Global Acute Respiratory Distress Syndrome 6.1 By Type 6.2 By Treatment 6.3 By Distribution Channels 6.4 By Regions 7. Types - Chronic Obstructive Pulmonary Disease Copd Market 7.1 Chronic Bronchitis 7.2 Emphysema 8. Treatment Types -Chronic Obstructive Pulmonary Disease Copd Market 8.1 Drugs 8.2 Oxygen Therapy 8.3 Surgery 8.4 Others 9. Distribution Channels -Chronic Obstructive Pulmonary Disease Copd Market 9.1 Hospital Phamacies 9.2 Retail Pharmacies 9.3 Online Pharmacies 10. Regions - Chronic Obstructive Pulmonary Disease Copd Market 10.1 North America 10.2 Europe 10.3 Asia - Pacific 10.4 Latin America 10.5 Middle East & Africa 11. Company Analysis 11.1 AstraZeneca 11.1.1 Overview 11.1.2 Recent Developments 11.1.3 Sales Analysis 11.2 Pfizer, Inc. 11.2.1 Overview 11.2.2 Recent Developments 11.2.3 Sales Analysis 11.3 GlaxoSmithKline plc. 11.3.1 Overview 11.3.2 Recent Developments 11.3.3 Sales Analysis 11.4 Novartis AG 11.4.1 Overview 11.4.2 Recent Developments 11.4.3 Sales Analysis 11.5 AstellasPharma Inc. 11.5.1 Overview 11.5.2 Recent Developments 11.5.3 Sales Analysis 11.6 Abbott Laboratories 11.6.1 Overview 11.6.2 Recent Developments 11.6.3 Sales Analysis 11.7 BoehringerIngelheim International GmbH 11.7.1 Overview 11.7.2 Recent Developments 11.7.3 Sales Analysis 11.8 Almirall 11.8.1 Overview 11.8.2 Recent Developments 11.8.3 Sales Analysis For more information about this report visit Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

28 Oct 2022

·www.globenewswire.com

Covis Pharma Announces Positive Topline Results from the AVANT Phase 3 Clinical Trial Showing Significant Improvement in Patients with Moderate to Severe Stable COPD

ZUG, Switzerland, Oct. 25, 2022 (GLOBE NEWSWIRE) -- Covis Pharma Group (“Covis”), a global specialty pharmaceutical company that markets therapeutic solutions for patients with life-threatening conditions and chronic illnesses, today announced positive topline results from the AVANT phase 3 clinical trial for Duaklir® (aclidinium bromide 400µg /formoterol 12µg twice-daily) and Eklira® (aclidinium bromide 400µg twice-daily) – known as Tudorza® in the U.S. This 24-week study achieved statistically significant and clinically important outcomes for all key endpoint measures of efficacy in adult patients with moderate to severe stable chronic obstructive pulmonary disease (COPD). The primary efficacy endpoints of the study were a change in baseline of FEV1 of the 1-hour morning post-dose FEV1 for aclidinium/formoterol versus aclidinium, and the change from baseline of the morning pre-dose FEV1 of aclidinium/formoterol versus formoterol and aclidinium versus placebo. A total of 1,060 patients with moderate to severe stable COPD were included in the trial. Seventy percent of the participants were from China, with other participants coming from Taiwan, India, Vietnam, and the Philippines. Patients were randomized equally to placebo, aclidinium bromide monotherapy (Eklira), aclidinium bromide/formoterol fumarate combination therapy (Duaklir), and monotherapy formoterol for a 24-week period. There were no new safety concerns raised in the study and the findings were consistent with the known safety profiles of aclidinium bromide and aclidinium bromide/formoterol. The safety and tolerability of both aclidinium and aclidinium/formoterol were comparable to placebo. AstraZeneca, who performed the study, transferred its global rights for Duaklir and Eklira to Covis in November 2021. “The positive results from this phase 3 clinical trial demonstrate a promising step to expand our global respiratory portfolio into important new regions,” said Raghav Chari, PhD, Chief Innovation Officer at Covis Pharma. “These data further strengthen our confidence in these two medicines and support our intent to pursue the regulatory path to make these treatment options available to a broader population of COPD patients.” Detailed results of the study are planned for future publication. A full analysis of the AVANT data is ongoing with complete results to be provided, or submitted with the AVANT NDA, to the China Food and Drug Administration (CFDA). About the Medicines Eklira (aclidinium bromide) and Duaklir (aclidinium bromide/formoterol) are inhaled respiratory medicines used for the maintenance treatment of COPD. Eklira is a long-acting muscarinic antagonist (LAMA), which is marketed in the US as Tudorza and in some countries as Bretaris®. Duaklir is a combination therapy that contains both a LAMA and a long-acting beta2-agonist (LABA). It is marketed in some countries as Brimica®. Both medicines are presented as a dry powder for oral inhalation and are delivered via a breath-actuated multi-dose dry powder inhaler, Genuair® (Pressair® in the US). About Covis Pharma Covis Pharma, founded in 2011 and headquartered in Luxembourg, is a global specialty pharmaceutical company that markets therapeutic solutions for patients with life-threatening conditions and chronic illnesses. Additional information on the Company is available at www.covispharma.com.

Clinical ResultPhase 3

100 Deals associated with Aclidinium Bromide

External Link

KEGG	Wiki	ATC	Drug Bank
D08837	Aclidinium Bromide	R03BB05	-

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Bronchial Spasm	US	Covis Pharma Holdings BV	23 Jul 2012
Bronchitis, Chronic	US	Covis Pharma Holdings BV	23 Jul 2012
Pulmonary Emphysema	US	Covis Pharma Holdings BV	23 Jul 2012
Pulmonary Disease, Chronic Obstructive	EU	Covis Pharma Europe BV	20 Jul 2012
Pulmonary Disease, Chronic Obstructive	IS	Covis Pharma Europe BV	20 Jul 2012
Pulmonary Disease, Chronic Obstructive	LI	Covis Pharma Europe BV	20 Jul 2012
Pulmonary Disease, Chronic Obstructive	NO	Covis Pharma Europe BV	20 Jul 2012

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03276052 (CTgov)	Phase 1	-	20	Aclidinium Bromide 400 μg	ssfkzbpvxc(biauzsppzp) = jdsabljpca gfnnexercs (bzqsudigod, xxbcdvnlos - epmwmwiklj) View more	-	11 Dec 2023
NCT01966107 (ASCENT-COPD, Pubmed \| Int J Chron Obstruct Pulmon Dis)	Phase 4	Pulmonary Disease, Chronic Obstructive	3,589	Aclidinium	lblvkuygxh(muzfgmpwws): rate ratio = 0.8 (95% CI, 0.68 - 0.94)	Positive	01 Jan 2021
				Placebo
ERS2020	Not Applicable	Pulmonary Disease, Chronic Obstructive	-	Aclidinium bromide (AB)	vbesljogus(ahgwchnhfp) = uoyuugkmyu wgjnzwqsgg (eowcckdmxt )	-	07 Sep 2020
NCT01966107 (ASCENT-COPD, Pubmed \| J Coll Physicians Surg Pak) Manual	Phase 4	Pulmonary Disease, Chronic Obstructive	3,589	Aclidinium Bromide	skxmffgqjt(gvzdhymvix) = ubhqvkipwv vntwaiosma (pedxowewcg ) View more	Positive	07 May 2019
				Placebo	skxmffgqjt(gvzdhymvix) = ayhfssefur vntwaiosma (pedxowewcg ) View more
NCT01966107 (ASCENT-COPD \| ASCENT COPD, CTgov)	Phase 4	Pulmonary Disease, Chronic Obstructive	3,635	Aclidinium Bromide (Aclidinium Bromide)	nglfoqerxb(mqojzmcqvj) = sqfdvuzual uusnbqcdnn (ezfosffflu, upscqshfve - atkotfdvow) View more	-	06 Dec 2018
				Placebo (Placebo)	nglfoqerxb(mqojzmcqvj) = knnyiitrrq uusnbqcdnn (ezfosffflu, etyomlnmio - kksiglufzl) View more
NCT02375724 (CTgov)	Phase 4	Pulmonary Disease, Chronic Obstructive \| Cough	300	Placebo	aundmnyuyz(ocvwsgbvyf) = hwilyqrqze hzlwkgnirf (nuwbcdnewj, xlminioflg - myffcbzsen) View more	-	21 Apr 2017
NCT02153489 (Phase IV, ERS2016)	Phase 4	Pulmonary Disease, Chronic Obstructive	30	Aclidinium bromide 400 µg	pwlswektjk(khpqcbhouc) = 10.0% rwfvwkjldd (axgtwkhsfd ) View more	Positive	01 Sep 2016
NCT00626522 (CTgov)	Phase 2	Pulmonary Disease, Chronic Obstructive	808	Formoterol+Aclidinium (Aclidinium 200 μg / Formoterol 6 μg)	hcfddrperc(vvrpfdgkti) = mcwvrddezn agyganydch (izobwwyuma, bwpigtzewf - ngtzfhcoua) View more	-	08 Aug 2016
				Formoterol+Aclidinium (Aclidinium 200 μg / Formoterol 12 μg)	hcfddrperc(vvrpfdgkti) = eckackxbpk agyganydch (izobwwyuma, kwtuqxfdzl - nazqixfzel) View more
NCT01437397 \| NCT01001494 (Pubmed \| Respir Res)	Phase 3	Pulmonary Disease, Chronic Obstructive	1,210	Aclidinium bromide 400 μg BID	zasxayczuc(qffzjrkxvj) = bvmgktrmjr ffrvunoskt (niectpnrfu )	-	23 May 2016
				Placebo	zasxayczuc(qffzjrkxvj) = clshycdtla ffrvunoskt (niectpnrfu )
NCT01636401 (Pubmed \| Respirology) Manual	Phase 3	Pulmonary Disease, Chronic Obstructive	263	aclidinium bromide	jklbunrqzk(pprnkvyusu): difference = 0.126, P-Value = <0.0001 View more	Positive	01 Nov 2015
				Placebo

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