Novel Antibiotic Zosurabalpin In Final Clinical Trial
The Swiss multinational pharmaceutical and diagnostics company Roche’s ambitious research project novel antibiotic, zosurabalpin, is in phase 3 testing. The first new antibiotic in 50 years, the zosurabalpin is considered effective for carbapenem-resistant Acinetobacter baumannii (CRAB), a ‘superbug’ considered an ‘urgent threat’, Pharmaphorum.com reported.
The leap is considered a big step forward in the fight against antimicrobial resistance (AMR). The superbug bacteria are currently resistant to most of the antibiotics, making the standard treatment ineffective, and these bacteria could cause 60% mortality. In 2019, India recorded 2,97,000 deaths directly attributable to anti-microbial resistance, according to a report published by the University of Washington. CRAB is a specific example of antimicrobial resistance, which refers to the broader phenomenon of bacteria becoming resistant to various types of antibiotics, including carbapenems.
The report regarding the pivotal testing phase comes less than 18 months after Roche started human testing of zosurabalpin, which could become the first new treatment for Gram-negative bacterial infections in around 50 years if it makes it through to regulatory approval.
The Swiss pharma firm is targeting CRAB due to the desperate need for new antibiotics to treat the infection, which the WHO says is one of the highest priority pathogens among those most threatening public health.
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The third trial is scheduled to start towards the end of this year or early in 2026, and it will enroll around 400 patients around the world who are hospitalized with invasive CRAB infections and who are at risk of dying from their infection, the report said.
However, the new antibiotic will be compared to standard-of-care treatment for CRAB infections, which kill thousands of people every year.
As per Roche, the decision to move into phase 3 testing follows the completion of various phase 1 studies that backed the drug’s safety, tolerability, and pharmacokinetics.
Zosurabalpin works by inhibiting the trafficking of LPS from the interior of the bacteria into the outer membrane. Blocking tha process causes the bacteria to die, thus working to dismantle the bacteria.
Zosurabalpin will not be affected by pre-existing resistance mechanisms, and its discovery could lay the foundations for future efforts to tackle AMR. AMR could cause up to 10 million deaths annually by 2050, as per some estimates, making it a menace as equalling current fatalities from cancer.
“Zosurabalpin is a so-called ‘narrow spectrum’ antibiotic, meaning that it has activity against Acinetobacter specifically,” the report quoted Roche’s head of immunology product development Larry Tsai.
The pharma group expects that further clinical trials will show that zosurabalpin can help tackle the rising issue of antibiotic resistance and addresses the major disease.
