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While the Phase II portion of the study evaluating AN2’s epetraborole met the primary endpoint, it failed in a “key” secondary endpoint prompting trial termination. Image Credit: kora_sun / Shutterstock. AN2 Therapeutics has implemented cost-saving measures after “disappointing” topline results from Phase II part of the Phase II/III trial evaluating its lead antibiotic, epetraborole. The antibiotic’s development suffered a major setback a few months ago after AN2 voluntarily stopped enrolment in the Phase III portion of the trial. The decision followed a blinded aggregate data analysis indicating “potentially lower than expected efficacy”. Following the news, AN2’s stock was down by over 22.7% in premarket trading today (9 August), compared to the market close on 8 August. The company’s stock has been floundering since it took a nosedive in February after AN2 announced plans to pause enrolment in the Phase III portion of the trial. AN2 plans to cut 50% of its workforce by the end of the year. The restructuring is expected to cost approximately $2m – $3m. Furthermore, AN2’s chief medical officer, Dr Paul Eckburg, will leave the company by 30 August as part of the restructuring. The cost savings measures are expected to provide AN2 a cash runway through 2027. With the announcement of job cuts, AN2 joins the likes of FibroGen , Aerovate Therapeutics and Allakos , all of which have reduced their headcounts after trial failures this year. See Also: Bavarian Nordic wins positive CHMP opinion to amend Imvanex approval EAN 2024: anti-CGRPs more effective than onabotulinumtoxinA in chronic migraine prevention in real world Epetraborole is a bacterial leucyl-tRNA synthetase inhibitor. AN2 licensed the therapy from Pfizer , who gained it as part of a $5.2bn acquisition of Anacor Pharmaceuticals . AN2 was evaluating epetraborole as a treatment for refractory mycobacterium avium complex (MAC) lung disease. The placebo-controlled Phase II/III trial (NCT05327803) enrolled 80 patients with treatment refractory MAC lung disease. Although the Phase II portion met its primary endpoint of patient-reported response, there was no significant difference between the treatment and placebo arms in a “key” secondary endpoint of sputum culture conversion at six months. Whilst AN2 has shut down the development of epetraborole in MAC lung disease, it plans to start a Phase II trial evaluating the therapy in melioidosis, a bacterial infection. Another therapy in AN2’s pipeline is AN2-502998 for the treatment of Chagas disease , an infectious illness caused by a parasite transmitted by ticks.

MicuRx showcased the latest research progress on their pipeline products, MRX-5 and MRX-8, at the 7th World Bronchiectasis Conference Three significant study results further support the potential of MRX-5 and MRX-8 in treating Nontuberculous Mycobacteria (NTM) lung disease and Pseudomonas aeruginosa infections DUNDEE, Scotland, July 18, 2024 /PRNewswire/ -- Shanghai MicuRx Pharmaceutical Co., Ltd. ("MicuRx"，688373.SH) presented the latest research progress on their novel antibiotic pipeline products, MRX-5 and MRX-8, at the 7th World Bronchiectasis Conference (WBC) held in Dundee, Scotland, from July 4 to 6, 2024. These research results provide new hope for the future treatment of Nontuberculous Mycobacteria (NTM) lung disease and Pseudomonas aeruginosa infections. Conference Background Continue Reading The World Bronchiectasis Conference is a leading global academic conference focused on the research and treatment of bronchiectasis. This conference brings together top scientists and clinical experts from around the world to discuss the latest research developments, clinical management strategies, and the development of new therapies for bronchiectasis. Research Highlights As a biopharmaceutical company dedicated to developing innovative anti-infective drugs, MicuRx presented three significant research results in poster presentation at the conference. These studies further support the potential of MRX-5 and MRX-8 in the treatment of specific infections： In Vitro and In Vivo Activity of A Novel Leucyl-tRNA Synthetase Inhibitor Against Mycobacterium Abscessus The active drug MRX-6038 was very potent against M. abscessus clinical isolates in vitro with MIC90 0.5 mg/L while the control drug clarithromycin MIC90 was 4 mg/L. MRX-6038 greatly reduced the resistance frequency of standard of care drugs (Ethambutol, Clarithromycin, Rifabutin, Clofazimine, Amikacin, Imipenem, Ciprofloxacin) by more than 10 to 100,000 folds, demonstrating the potential for combination with the background therapy. Oral prodrug MRX-5 was tested in mice with lung infections due to M. abscessus isolates, and efficacy was demonstrated against infections with both clarithromycin-sensitive and clarithromycin non-susceptible isolates. In Vitro Activity of Novel Leucyl-tRNA Synthetase Inhibitor Against Mycobacterium Avium Complex MRX-6038, the major activedrug of MRX-5, has demonstrated potent in vitro activity against Mycobacterium avium clinical isolates including isolates not susceptible to clarithromycin. When MRX-6038 was combined with Clarithromycin, Rifabutin, Amikacin, and Ethambutol, the resistance frequency of these standard of care drugs was greatly reduced to below 6.5×10-11. Further studies are warranted for the evaluation of MRX-6038 for the treatment of Mycobacterium avium pulmonary disease. In Vitro and In Vivo Activity of A Novel Antibiotic In The Polymyxin Class Against Pseudomonas Aeruginosa MRX-8 demonstrated potent in vitro activity against P. aeruginosa including tobramycin and amikacin resistant clinical isolates. In mouse models with P. aeruginosa lung infections of both tobramycin-sensitive and tobramycin-resistant isolates, nebulized MRX-8 treatment significantly decreased bacterial load in the lung tissues, demonstrating bactericidal activity. About MRX-8 MRX-8 is a novel polymyxin antibiotic developed by MicuRx, primarily used to treat severe infections caused by multidrug-resistant Gram-negative bacteria. Traditional polymyxins are limited in clinical use due to nephrotoxicity and neurotoxicity. Through meticulous structural design, MRX-8 not only maintains or enhances therapeutic efficacy but also significantly improves safety by reducing these potential toxic risks. In 2022, MRX-8 completed Phase I clinical trials in the United States. In 2023, it completed Phase I enrollment in China, with primary study results released in June 2024. These trial results indicated that MRX-8 achieved the desired therapeutic levels in the human body at the expected clinical doses for infections caused by Escherichia coli, Pseudomonas aeruginosa, and Acinetobacter baumannii. Besides systemic administration, the company plans to explore the development of an inhaled formulation of MRX-8 to uncover its clinical and commercial value in targeted treatment of chronic lung infections. About MRX-5 and NTM MRX-5 is a novel benzoxaborole antibiotic developed by MicuRx for infections caused by NTM. NTM is a common pathogen causing bronchiectasis. In recent years, the incidence of NTM diseases has rapidly increased, becoming a significant public health issue. [1] Among diseases caused by NTM, Mycobacterium avium complex and Mycobacterium abscessus complex account for 70%-95% of NTM diseases. [2] The main clinical symptoms of NTM pulmonary infections include persistent cough, sputum production, chest pain, shortness of breath, fatigue, weight loss, and malaise. [1] Preclinical data indicates that MRX-5 has good antibacterial activity against most common NTM pathogens and has demonstrated good safety in animal studies. Additionally, its characteristics of minimal drug interactions, low resistance potential, and oral availability make it an ideal candidate for the treatment of chronic infections. Currently, MRX-5 is undergoing Phase I clinical trials, offering a promising new treatment option for patients with NTM diseases. About Shanghai MicuRx Pharmaceutical Co., Ltd. MicuRx is a biopharmaceutical company focusing on novel therapeutics for infectious diseases. With global independent intellectual property and competitiveness, we are committed to the discovery, development, and commercialization of innovative drugs for unmet medical needs. Since the company was founded in 2007, MicuRx has adhered to the principle of "Better therapy through superior medicine", focusing on the increasingly serious problem of global antimicrobial resistance. For more information, please visit our website at References： SOURCE MicuRx Pharmaceutical

SHANGHAI, June 19, 2024 /PRNewswire/ -- Shanghai MicuRx Pharmaceutical Co., Ltd. ("MicuRx", 688373.SH), a multi-asset biopharmaceutical company focused on the discovery and development of novel anti-infective therapies for treating life-threatening infections, today announced 3 new studies will be presented at the 7th World Bronchiectasis Conference, taking place from July 4 - 6, 2024 in Dundee, Scotland. The presentations will showcase nonclinical data for MRX-5 and MRX-8. MRX-5 is an oral investigational candidate for the treatment of adults with nontuberculous mycobacteria (NTM) pulmonary diseases. MRX-5 demonstrates potent antimicrobial activity against Mycobacterium avium complex (MAC), the most common NTM pathogen, as well as Mycobacterium abscessus complex (MABC), the more difficult-to-treat NTM. MRX-5 is currently in Phase 1 clinical studies and topline results are expected in late 3Q2024. MRX-8 is a novel compound in the polymyxin class. Nebulized MRX-8 is developed for treating chronic Pseudomonas aeruginosa lung infection in patients with bronchiectasis, including infections caused by drug resistant isolates. Presentations pertaining to MRX-5 and MRX-8: Title: In Vitro And In Vivo Activity Of A Novel Leucyl-Trna Synthetase Inhibitor Against Mycobacterium Abscessus Presenting Author: Regis Vilchez, MD, PhD (MicuRx) Title: In Vitro Activity of Novel Leucyl-tRNA Synthetase Inhibitor Against Mycobacterium Avium Complex Presenting Author: Wen Wang, PhD (MicuRx) Title: In Vitro And In Vivo Activity Of A Novel Antibiotic In The Polymyxin Class Against Pseudomonas Aeruginosa Presenting Author: Wen Wang, PhD (MicuRx) About MicuRx MicuRx is a biopharmaceutical company focusing on novel therapeutics for infectious diseases. With global independent intellectual property and competitiveness, we are committed to the discovery, development, and commercialization of innovative drugs for unmet medical needs. Since the company was founded in 2007, MicuRx has adhered to the principle of "Better therapy through superior medicine", focusing on the increasingly serious problem of global antimicrobial resistance. For more information, please visit our website at View original content to download multimedia: SOURCE MicuRx Pharmaceuticals Company Codes: Shanghai:688373