Antibiotic resistance is one of the greatest threats to global public health. It happens when germs like bacteria develop the ability to defeat the drugs designed to kill them. This can be deadly. In 2019, antimicrobial resistance was estimated to have killed at least 1.27 million people worldwide, and was associated with nearly five million deaths, according to a report released in The Lancet. Therefore, the biotech industry now has a major role to play in the discovery and development of novel therapies to overcome the issue of antibiotic resistance and tackle drug-resistant infections. In this article, we take a look at six companies at the forefront of the antibiotic resistance field.
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Acurx Pharmaceuticals
Acurx Pharmaceuticals is focused on developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections. Its approach is to develop antibiotic candidates that block a new molecular target called DNA polymerase IIIC, thereby inhibiting DNA replication and leading to Gram-positive bacterial cell death. The company’s pipeline includes one clinical stage program and two preclinical candidates that target Gram-positive bacteria, including Clostridioides difficile, Enterococcus, Staphylococcus, and Streptococcus.
The antibiotic company’s lead candidate is called ibezapolstat and is intended to treat patients with C. difficile infection. It is the first of Acurx’s DNA polymerase IIIC inhibitors under development. Acurx has successfully completed a phase 2a and 2b trial of ibezapolstat and, in November 2023, the company announced positive topline efficacy results for it. In a total of 26 patients treated with ibezapolstat in phases 2a and 2b, the clinical cure rate was 96%. Furthermore, the drug was well tolerated and no drug-related serious adverse events were reported.
According to Acurx, planning is now underway with the U.S. Food and Drug Administration (FDA) to advance ibezapolstat into international phase 3 clinical trials, with an end-of-phase 2 meeting with the regulatory agency confirmed to occur in late April 2024 to finalize the phase 3 development plan.
Antabio
Antabio is developing novel and highly differentiated antibacterial treatments for drug-resistant infections as defined by the Centers for Disease Control and Prevention (CDC) and the World Health Organization’s (WHO’s) critical priority pathogens, with a particular focus on life-threatening respiratory infections, including carbapenem-resistant nosocomial pneumonia and chronic pulmonary diseases.
The company’s lead program, MEM-ANT3310, is being developed for the treatment of hospital-acquired infections, such as nosocomial pneumonia caused by carbapenem-resistant Acinetobacter baumannii and carbapenem-resistant Enterobacterales. MEM-ANT3310 combines meropenem (a well-known carbapenem antibiotic) with ANT3310, a serine-beta-lactamase (SBL) inhibitor developed by Antabio. The company says that this combination has been designed to provide unique coverage for priority Gram-negative pathogens, including OXA-carbapenem-resistant A. baumannii, KPC- and OXA-carbapenem-resistant Enterobacterales, and Pseudomonas aeruginosa (PA). The first patients were dosed in a phase 1 trial of MEM-ANT3310 in May last year.
Antabio also recently raised €25 million ($27.2 million) in series B funding. The proceeds from this will be used to support the clinical development of MEM-ANT3310, enabling the company to complete phase 2 clinical studies for the candidate.
BiomX
BiomX is developing both natural and engineered phage cocktails designed to target and destroy harmful bacteria in chronic diseases, such as cystic fibrosis, inflammatory bowel disease, atopic dermatitis, and colorectal cancer. Phages essentially target and rapidly kill their bacterial hosts by amplifying inside bacteria and releasing new phages by bursting through the host cell membrane into the surrounding environment. These newly released phages then infect and kill additional nearby bacterial cells in a reiterative process that leads to the elimination of the target bacteria.
Just yesterday, on March 6, BiomX announced that it had entered into a definitive merger agreement with fellow antibiotic resistance biotech Adaptive Phage Therapeutics (APT) to create a company focused on pushing two engineered phage therapies through the clinic. Following the all-stock transaction, around 55% of the resulting company will be owned by BiomX’s current shareholders, while the remaining 45% will be owned by APT’s shareholders.
In the same press release, BiomX also announced that it will sell $50 million worth of the new entity’s stock. The proceeds from this private placement are expected to provide funding for phase 2 readouts for the company’s two lead programs. These include results from a phase 2b trial that will evaluate BiomX’s lead product candidate, BX004, for the treatment of chronic pulmonary infections caused by Pseudomonas aeruginosa in cystic fibrosis patients – expected in the third quarter of 2025 – and phase 2 results from APT’s clinical-stage product candidate, now named BX211, for the treatment of Staphylococcus aureus infections in diabetic foot osteomyelitis patients – expected in the first quarter of 2025.
Clarametyx Biosciences
Launched in 2020 to advance a novel, immune-enabling antibody technology licensed from Nationwide Children’s Hospital, Clarametyx Biosciences is combating persistent infections through a technology platform targeting the biofilm – a protective layer around bacteria – to enable a more effective immune response and antibiotic intervention. The company is currently building a pipeline of immune-enabling therapies and vaccines for life-threatening bacterial infections associated with biofilms, with a near-term focus on challenging respiratory infections.
Clarametyx’s lead candidate is an immune-enabling antibody therapy known as CMTX-101. It is intended to be administered at the same time as a wide range of standard-of-care antibiotics that target both Gram-negative and Gram-positive bacteria and is designed to precisely and rapidly destroy the universal underlying structure of bacterial biofilms. Because biofilms are universally present across bacteria, the therapy can be employed to treat a range of bacterial infections, many of which are characterized by the presence of multiple types of bacteria.
In January, the company announced that it had raised $33 million in series A financing, which will now enable it to accelerate efforts across its pipeline, including evaluating the potential of CMTX-101 to combat infection in people with cystic fibrosis. In coordination with the fundraising, Clarametyx also initiated a phase 1b/2a clinical trial evaluating CMTX-101 in people with cystic fibrosis.
MinervaX
MinervaX was established to develop a prophylactic vaccine against Group B Streptococcus (GBS) based on research from Lund University. MinervaX is developing a GBS vaccine for maternal immunization – as GBS can cause potentially devastating infection in newborn infants – with trial data suggesting superior efficacy compared with other GBS vaccine candidates in development, which are based on traditional capsular polysaccharide (CPS) conjugate technology. By contrast, MinervaX’s vaccine is a protein-only vaccine based on fusions of highly immunogenic and protective protein domains from selected surface proteins of GBS.
The company’s maternal GBS vaccine is in phase 2 of development, with MinervaX currently progressing two phase 2 clinical trials in 470 pregnant people across Denmark (where the company is based), the U.K., Uganda, and South Africa. Initial data from these clinical trials are positive and demonstrate that the vaccine has an acceptable safety profile, is highly immunogenic, and gives rise to functionally active antibodies. In addition to pregnant women, the vaccine is also being explored in a phase 1 trial for use in older adults, where GBS causes significant disease, such as sepsis, pneumonia, cellulitis, and soft tissue infections.
In October 2023, MinervaX raised €54 million ($58.9 million) in upsized financing, which will enable the antibiotic resistance company to progress its GBS vaccine towards phase 3 clinical trials at some point in 2024.
Venatorx
Venatorx is focused on improving health outcomes for patients with multidrug-resistant bacterial infections, as well as hard-to-treat viral infections. Venatorx’s lead program, cefepime-taniborbactam, is a clinical-stage antibiotic that completed a phase 3 study in adults with complicated urinary tract infections (cUTI), including pyelonephritis. Cefepime is a widely used beta-lactam antibiotic that works against susceptible gram-negative and gram-positive bacteria. Meanwhile, taniborbactam is a beta-lactamase inhibitor (BLI) that, in combination with cefepime, could be used as a potential treatment option for patients with serious bacterial infections caused by antibiotic-resistant gram-negative bacteria.
Venatorx is also developing an oral antibacterial, known as ceftibuten-ledaborbactam etzadroxil, for the treatment of cUTI caused by certain bacteria in adult patients with limited treatment options. The candidate is currently completing phase 1 of development and will advance directly to a global phase 3 cUTI trial.
In October 2022, BARDA awarded Venatorx a contract of up to $318 million for the development and procurement of cefepime-taniborbactam for the treatment of melioidosis and multi-drug resistant infections. Furthermore, in the same year, the antibiotic company was also one of the first beneficiaries of the AMR Action Fund’s $1 billion fund to address drug-resistant bacterial infections. And, late last year, Ventarox was awarded a third antibiotic BARDA contract that included a total award of up to $167 million for the development of ceftibuten-ledaborbactam etzadroxil.
AMR Action Fund: major investment in biotech to help combat antibiotic resistance
Because antimicrobial resistance is now such a major health threat around the world, there has been a big push in recent years to find novel ways of combating the issue. Biotech is at the forefront of this fight, as the AMR Action Fund was set up specifically to combat antibiotic resistance by investing $1 billion into clinical-stage companies to help bring new antibiotics to market. The concept was developed by the International Federation of Pharmaceutical Manufacturers & Associations and its member biopharmaceutical companies, in collaboration with WHO, the European Investment Bank, and the Wellcome Trust. Ultimately, the hope is that this initiative will allow biotech companies to more rapidly bring their clinical candidates to market in order to alleviate the threat of antimicrobial resistance.