During IDWeek 2024 in Los Angeles, California, novel antimicrobials in the development pipeline that are poised to make a difference were highlighted.
Gonorrhoea, a sexually transmitted infection (STI) caused by the bacterium Neisseria gonorrhoea, is the second most prevalent bacterial STI. Between 2009 and 2020, the global incidence of gonorrhoea increased by 111%. Furthermore, 2023 had the highest incidence of gonorrhoea in the UK since recording first began in 1918. Zoliflodacin is a first-in-class, spiropyrimidinetrione antibiotic, indicated for the treatment of uncomplicated gonorrhea. Zoliflodacin is an oral, single-dose medication, which works by targeting the GyrB subunit of DNA gyrase to inhibit DNA replication. A pivotal Phase III trial of zoliflodacin reported positive safety and efficacy data. Zoliflodacin was found to be non-inferior to the active comparator, ceftriaxone + azithromycin, with microbiological cure rates of 90.9% in patients with urogenital gonorrhoea, 79.2% in patients with pharyngeal infections, and 87.3% in patients with rectal infections. This was compared to 96.2%, 78.6%, and 86.6%, respectively, in patients taking ceftriaxone + azithromycin. If approved, zoliflodacin could be a valuable treatment option, particularly as there was no emergence of zoliflodacin resistance detected during the study, and zoliflodacin has demonstrated in vitro activity against multidrug-resistant strains of gonorrhoea.
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Invasive fungal infections are another top concern, as outlined by the World Health Organization’s Fungal Priority Pathogens List. Fosmanogepix is a first-in-class, broad-spectrum antifungal, which can be administered orally or intravenously. Fosmanogepix has demonstrated potent activity against Candida spp., Aspergillus spp., Fusarium spp., Scedosporium spp., Lomentospora spp., Cryptococcus spp., as well as endemic moulds such as Blastomyces dermatitidis and Histoplasma capsulatum, other rare moulds such as Cladosporium spp. and Scopulariosis spp., and other rare yeasts such as Trichosporon asahii, Exophiala dermatitidis, and Malassezia furfur. Three Phase II studies were completed, all of which demonstrated positive efficacy and safety data. Global response rates from the three studies ranged from 40% to 89% by the end of the study treatment. Fosmanogepix has been available since April 2020 under an expanded access program (NCT06433128) for patients with serious invasive fungal infections and no other available treatment options. One Phase III trial began several weeks ago, and another Phase III trial is expected to begin at the end of 2024. Fosmanogepix has received qualified infectious disease product (QIDP) and fast track designations from the FDA for invasive candidiasis, invasive aspergillosis, scedosporiosis, fusariosis, mucormycosis, cryptococcosis, and coccidioidomycosis.
Two other antimicrobials that were highlighted were CMTX-101 and AIC468. CMTX-101 is an anti-biofilm therapeutic, which is intended to be administered along with the applicable standard of care (SOC). CMTX-101 was able to demonstrate in vitro activity against all bacterial biofilms, including the ESKAPE pathogens (Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumanii, Pseudomonas aeruginosa, and Enterobacter spp.). Topline data from a Phase Ia/Ib trial showed that all doses were well tolerated, no neutralising antibodies were seen in healthy individuals, and select biomarkers appeared to improve in a dose-dependent fashion. CMTX-101 has just begun Phase II dosing. AIC468 is a first-in-class antiviral antisense oligonucleotide (ASO) for the treatment of BK virus (BKV) in kidney transplant recipients. Preclinical testing of AIC468 in a mouse model demonstrated significant in vivo reduction of T-Ag mRNA expression, and that AIC468 reaches the target organ at high concentrations and with a long tissue half-life. A Phase I trial is set to begin later this month.
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