Plazomicin Sulfate

Mumbai: Respiratory drugs major Cipla has launched Plazomicin a novel treatment for drug resistant complicated Urinary Tract Infections (cUTI) including pyelonephritis in India. The novel injectable was in-licensed by Cipla from a US-based biopharmaceutical company Achaogen and the Indian drug maker US-arm had acquired the drug worldwide rights in 2019 (excluding Greater China) with its allied assets and limited liabilities. In India the drug has been launched under its global brand name ‘ Zemdri ’. As per the company the novel injectable approval was supported by data from the EPIC (Evaluating Plazomicin In cUTI) clinical trial, which was the first randomized controlled study of once-daily aminoglycoside therapy for the treatment of cUTI, including pyelonephritis. The drug has shown promising activity against Indian multi-drug resistant (MDR) isolates including those expressing PBP-3 inserts and Cipla has generated Indian-specific pathogen data to address this urgent need, it added. “We are proud to be the first pharmaceutical company to launch Zemdri in India and remain committed to developing a robust antimicrobial portfolio , forging partnerships with thought leaders and industry alliances to ensure global access to antimicrobial drugs for a healthier life,” Umang Vohra , Managing Director and Global CEO, Cipla, commented. Plazomicin is a new intravenous (IV) aminoglycoside indicated in patients 18 years of age or older for the treatment of cUTIs including pyelonephritis caused by the susceptible microorganisms such as Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Enterobacter cloacae. The injectable during protein synthesis binds the 30S subunit of bacterial ribosomes and disrupts the misreading of mRNA. The novel antibiotic is stated to be effective against some of the cUTI-causing gram-negative bacteria that are resistant to beta-lactam antibiotics including carbapenems. A cUTIs (complicated UTIs) occur in those with underlying problem in the urinary tract, such as structural or functional abnormality, like kidney stones or diabetes and currently, the condition affects around 150 million patients each year across the globe. By Online Bureau ,

One year after BARDA backed ContraFect’s MRSA treatment, the Yonkers, NY-based biotech said Wednesday it will stop its Phase III trial of the asset early due to futility. The data safety monitoring board reviewed clinical response data from 84 patients, looking at superiority over the control arm at two weeks, and recommended the trial be stopped, the company said in a press release . The Phase III trial was originally designed to test exebacase — a lysin treatment that would dissolve bacteria cell walls — in 350 patients with bacteremia from MRSA, including those with right-sided heart inflammation. “This disappointing news reflects the long history of difficulties in treating life-threatening infections like MRSA bacteremia in patients with heterogeneous co-morbidities, and who are in need of immediate life-saving treatments,” ContraFect president and CEO Roger Pomerantz said in a statement. SVB Securities analysts Roanna Ruiz and Nik Gasic noted the unique trial design: ContraFect had designed its trial for superiority as opposed to non-inferiority in a risky bet to make exebacase an earlier treatment option for MRSA, a difficult-to-treat bacteria infection that led to some 20,000 deaths in 2017, according to the CDC. Why make that ambitious bet? When new antibiotics are approved on non-inferiority, they’re deemed a last resort , resulting in low returns for the developer. In 2019, Achaogen went bankrupt despite winning approval for Zemdri, its antibiotic for complicated urinary tract infections. BARDA had previously backed ContraFect on exebacase with an initial $9.8 million alongside $77 million in future payments. In reaction to the trial stoppage, ContraFect’s stock $CFRX all but collapsed, falling over 80% to around $0.50 this morning. In an email to Endpoints News , ContraFect CFO Michael Messinger said the biotech has not planned any non-inferiority trials for any of its programs, writing that “clinical superiority is critically important for new antibacterial therapies.” He added that ContraFect will “continue to evaluate the medical opportunities for exebacase, whether it remains in bacteremia or in another indication like prosthetic joint infections.” The antibiotic biotech plans to do its own analysis of the exebacase Phase III data before detailing future plans, according to the press release. On the financial end, Messinger noted the biotech was funded through 2022 prior to stopping enrollment in the study and is evaluating how its runway could be extended depending on the results of said analysis. This story was updated to include comment from Michael Messinger.