POL7306 belongs to a new class of peptidomimetic outer-membrane-protein-targeting antibiotics with a novel mechanism of action. POL7306 is in development for the treatment of infections caused by antimicrobial-resistant Gram-negative bacteria and has demonstrated low cytotoxicity and nephrotoxicity.

Methods:

A total of 891 isolates were collected by the SENTRY Antimicrobial Surveillance Program from 134 medical centres in Europe (n = 424; 41 centres in 18 nations), the USA (n = 411 isolates from 67 centres), the Asia-Pacific region (n = 24; 15 centres in 6 nations) and Latin America (n = 32; 11 centres in 9 nations) and included 558 Enterobacterales, 310 non-fermenters and 23 fastidious organisms. Susceptibility testing was performed using the reference broth microdilution method and the medium was supplemented with 0.002% polysorbate-80 for testing POL7306. Resistant subsets were characterized by WGS.

Results:

POL7306 demonstrated potent in vitro activity against Enterobacterales [including carbapenem-resistant (MIC50/90, 0.06/0.25 mg/L), ESBL-producing (MIC50/90, 0.06/0.12 mg/L), KPC-producing (MIC50/90, 0.12/0.25 mg/L), MBL-producing (MIC50/90, 0.06/0.25 mg/L), colistin-non-susceptible, mcr-negative (MIC50/90, 0.5/2 mg/L) and mcr-positive (MIC50/90, 0.12/0.25 mg/L) Enterobacterales], Pseudomonas aeruginosa (MIC50/90, 0.25/0.25 mg/L), Acinetobacter baumannii (MIC50/90, 0.06/0.12 mg/L) and Stenotrophomonas maltophilia (MIC50/90, 0.06/0.25 mg/L).

Conclusions:

POL7306 demonstrated potent activity against a large collection of Gram-negative organisms collected worldwide that included colistin-resistant, XDR and ESBL- and carbapenemase-producing isolates for which there are currently limited treatment options.

项与 POL-7306 相关的新闻（医药）

2024-01-15

·Pharmaceutical Technology

Basilea buys Spexis’ preclinical antibiotics programme for $2.3m

Antimicrobial resistance (AMR) has been a growing issue in recent years, with the World Health Organisation (WHO) declaring it one of the top global public health and development threats. Image Credit: veronikalove / Shutterstock. Switzerland-based Basilea Pharmaceutica has entered into an asset purchase agreement with Spexis to acquire the latter’s preclinical program of antibiotics in a deal worth SFr2m ($2.3m). Basilea will pay up to SFr2m in upfront, asset transfer and milestone-based payments. Furthermore, Basilea will also assume licencing rights and obligations from Spexis, royalties on sales which were promised under licensing agreements, as per a 15 January press release. Following the news, the stock for Switzerland based Spexis went up by over 16.7% during trading on 15 January. Spexis’ antibiotic programme was developed using its outer membrane protein targeting antibiotics (OMPTA) technology that selectively disrupts the lipopolysaccharide transport bridge. The new OMPTA class of antibiotics binds dually to lipopolysaccharide and outer-membrane proteins. These proteins are responsible for providing structural integrity and a permeability barrier to protect the gram-negative bacterial cell. Its disruption can cause the bacteria to die. Spexis’ OMPTA class molecule POL7306 is currently in pre-clinical development. The Spexis’ antibiotic programme was funded in part by Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), a global non-profit partnership established to accelerate antibacterial products to address drug-resistant bacteria. Basilea’s pipeline consists of multiple antifungals and antibiotics. The company is seeking approval from the US Food and Drug Administration (FDA) for its antibiotic ceftobiprole. The Prescription Drug User Fee Act (PDUFA) goal date for the new drug application (NDA) for ceftobiprole is set for 3 April 2024. Concurrently, the company is also seeking a partner to commercialise the drug in the US . Antimicrobial resistance (AMR) has been a growing issue in recent years, with the World Health Organisation (WHO) declaring it one of the top global public health and development threats. In August 2023, the UK pledged up to £210m ($267.7m) to help track antibiotic-resistant bacteria across Asia and Africa. The investment aimed to identify dangerous superbugs before they arrived in the country. In recent months, multiple companies have invested in developing antibiotic therapies. In September 2023, Novo Holding acquired Boston-based Paratek Pharmaceuticals to bolster its AMR expertise. Paratek’s portfolio consisted of Nuzyra (omadacycline), a marketed once-a-day oral and intravenous antibiotic indicated for CABP and ABSSSI.