Aclidinium Bromide/Formoterol Fumarate

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.

China’s Clover Biopharmaceuticals has begun construction on a new R&D center. The state-of-the-art facility will be built over 25,000 square meters of real estate. Construction is expected to be completed in the second half of 2022. Clover is building its new site in Zhangjiang Biotech and Pharmaceutical Industrial Base, which has been dubbed“Zhangjiang Pharma Valley.” The valley is located in Zhangjiang Hi-Tech Park in Pudong, Shanghai. The valley is one of China’s top biohubs with more than 1,000 companies located in the area. The new facility will include new preclinical research laboratory facilities, manufacturing process development labs, and a GMP pilot manufacturing plant, Clover said in its announcement. With the new facility, Clover said it intends to bring on hundreds of new employees. Joshua Liang, chief executive officer of Clover Biopharmaceuticals said, the new site will allow the company to expand its R&D capabilities and accelerate its innovative pipeline. The Shanghai site is the first of several planned across the globe, Liang said in a statement. Elsewhere around the globe: Universe Pharmaceuticals – Also based in China, Universe Pharmaceuticals has entered into two strategic cooperation agreements with Jiangxi Province Institute of Materia Medical. The company authorized Jiangxi IMM to conduct six studies on the quality standard of formula granules of traditional Chinese medicine, including Isatis Root Granule, Epimedium, Sophora Flavescens, Ginseng, Angelica, and Astragalus. The company will provide related materials and samples to Jiangxi IMM for these studies. Centogene N.V. – Germany’s Centogene announced the global release of CentoCloud, a SaaS platform that provides for decentralized analysis, interpretation, and reporting of genomic variants linked to rare diseases. By providing a decentralized workflow, CentoCloud aggregates Next Generation Sequencing (NGS) data from laboratories into the cloud. From there, automated, curated, bioinformatic analysis and AI-based genomic variant prioritization and classification generate high quality reporting of high value. Ayala Pharmaceuticals – Israel-based Ayala announced key objectives for 2022, which includes expected data from the pivotal Phase II/III Ringside trial in Desmoid tumors. If successful RINGSIDE, which is assessing AL102, will be used as a registrational study. Roni Mamluk, CEO of Ayala, expressed the belief that 2022 will be a pivotal year for the company. In addition to desmoid tumors, the company is studying AL101 programs in adenoid cystic carcinoma and triple negative breast cancer. Oryzon Genomics SA – Based in Spain, Oryzon received approval from the Serbian Medicines and Medical Devices Agency to conduct a Phase IIb clinical trial with vafidemstat in patients with Borderline Personality Disorder (BPD) in that country. The trial is already active and recruiting patients in Spain, Bulgaria, Germany and the U.S. The trial, dubbed PORTICO, is a multicenter, double-blind, randomized, placebo-controlled, Phase IIb trial. The trial has two primary independent objectives: to reduce agitation and aggression and an overall improvement of BPD. Oryzon believes that vafidemstat could be transformative in the treatment and lives of BPD patients. Vafidemstat’s was designed to inhibit LSD1, reducing aggression, enhancing sociability and mitigating social withdrawal. The candidate demonstrated such capabilities in several preclinical models, the company said. Arch Biopartners, Inc. – Based in Toronto, Arch Biopartners announced that the Research Ethics Board at the Sunnybrook Research Institute has approved the amendment to the CATCO protocol to include its lead drug candidate, LSALT Peptide in a new arm of the CATCO human trial. Santhera Pharmaceuticals – Switzerland-based Santhera has entered into an exclusive license agreement with Sperogenix Therapeutics, a China-based company specializing in orphan diseases. Sperogenix has in-licensed vamorolone for rare disease indications, including Duchene Muscular Dystrophy. Sperogenix plans to initiate a regulatory filing for vamorolone for DMD in China upon approval from the U.S. Food and Drug Administration, which could lead to market entry in China as early as in 2024. There are currently no approved treatments for DMD in China. Sperogenix intends to proactively engage with the health authorities in China in order to achieve an accelerated regulatory pathway for vamorolone. Relief Therapeutics – Also based in Switzerland, Relief Therapeutics announced its partner NeuroRx, Inc. filed a provisional composition of matter patent application with the U.S. Patent and Trademark Office entitled, "Stable, Buffer-free Compositions of Vasoactive Intestinal Peptide (VIP)." Relief and NeuroRx are collaborating on the development of aviptadil. According to the announcement, the provisional application describes compositions of vasoactive intestinal peptide, the synthetic form of which is aviptadil, that are both shelf stable and biologically active when used to treat COVID-19 and other diseases. ProQR – Netherlands-based ProQR announced that the last patient completed the last visit in the Phase II/III ILLUMINATE trial, which is assessing sepofarsen for CEP290-mediated Leber Congenital Amaurosis 10 caused by the p.Cys998X mutation. The primary endpoint for ILLUMINATE is mean change from baseline in best-corrected visual acuity (BCVA) at Month 12. Everest Medicines – China’s Everest Medicines Limited announced that the Taiwan Food and Drug Administration (TFDA) has accepted the submission of a New Drug Application for sacituzumab govitecan (SG) in adult patients with unresectable locally advanced or metastatic TNBC who have received two or more prior systemic therapies, at least one of them for metastatic disease. SG has been granted Pediatric and Rare Severe Disease Priority Review Designation by the Taiwan FDA. SG has been previously approved under accelerated approval in the United States where it is sold as Trodelvy. Covis Pharma Group – Based in Switzerland, Covis announced it has completed the acquisition of Eklira (aclidinium bromide), which is known as Tudorza in the U.S. and marketed as Bretaris in some countries. The company also gained Duaklir (aclidinium bromide/formoterol), which is marketed as Brimica in some countries. Both drugs were gained from AstraZeneca. In addition, Covis announced it has entered into an exclusive promotion and distribution agreement with Novartis Pharmaceuticals Canada Inc. for the distribution of Seebri, Breezhaler and Ultibro Breezhaler in that country. PhoreMost – U.K.-based PhoreMost Limited and N.C.-based Polaris Quantum Biotech announced a collaboration to study oncology targets currently considered undruggable. Together, this partnership aims to discover and develop the next generation of oncology therapies. InflaRx NV – Germany-based InflaRx announced the initiation of the Phase III program with vilobelimab in hidradenitis suppurativa (HS) patients with active draining tunnels. The new primary endpoint, called modified HiSCR will include measuring the reduction of all three types of lesions – inflammatory nodules, abscesses and draining tunnels. F-Star Therapeutics – U.K.-based F-Star announced that Ares Trading S.A., an affiliate of Merck KGaA, Darmstadt, Germany, has exercised a fourth licensing option to develop another bispecific program under the ongoing immuno-oncology collaboration. Under the terms of the agreement, Merck KGaA, Darmstadt, Germany will be responsible for all future development and commercialization costs and will pay future success-based milestones and royalties on any net sales, resulting from programs covered by the agreement.