Precisio Biotix Therapeutics announced the successful first-in-human dosing of its engineered staph lysin ClyO (LYSG101) to treat a patient with a multi-drug resistant prosthetic joint infection that had failed to respond to conventional treatments. The FDA approved this compassionate care treatment under an Investigational New Drug (IND) application filed by Mayo Clinic.
The patient appears to have tolerated the treatment without any adverse events, though the company notes it is too early to assess full efficacy. This milestone represents a significant step toward providing additional therapeutic options for patients when traditional treatments have failed.
Novel Antimicrobial Mechanism
ClyO belongs to a promising new class of antimicrobials called direct lytic agents. Unlike traditional antibiotics, lysins actively hydrolyze the bacterial cell wall, causing extremely rapid lysis and cell death. This unique mechanism of action allows lysins to be targeted to specific pathogens, effectively degrade biofilms, and remain effective against bacteria resistant to traditional antibiotics.
Critically, lysins do not cause bacterial resistance, addressing a major limitation of conventional antimicrobial therapy. Dr. Raymond Schuch, VP and Director of US Operations at Precisio, explained that the company's "sole focus is the systematic engineering of native lysins and generation of drug-like, optimized and engineered lysins vs. antimicrobial-resistant human pathogens that are associated with high unmet medical needs."
Addressing Global Health Crisis
The treatment addresses a pressing global health issue. According to Dr. Assaf Raz, VP of Research and Development at Precisio, drug-resistant infections cause at least 700,000 deaths each year. Without decisive action, this number could rise to 10 million annually by 2050, according to the UN Ad hoc Interagency Coordinating Group on Antimicrobial Resistance.
"Our research team is dedicated to developing new lysin therapeutics for large areas of need that bypass antibiotic resistance," Dr. Raz noted. "We are highly encouraged that our technologies allow us to rapidly create effective solutions for multidrug-resistant pathogens, combating resistant infections and improving patient outcomes."
Platform Technology and Future Applications
Precisio utilizes multiple proprietary high-tech tools including bioinformatics, machine-learning, and AI platforms called Zeus™-LysiThru™ to develop optimized lysins. Mark Engel, Founder and CEO of Precisio, emphasized that the company has reached a point where it can develop lysin products against many infections, including those resistant to standard antibiotics.
"This patient at Mayo Clinic is the first of what we hope are many examples that we announce in the coming months," Engel said. "Doctors around the globe are anxious to start using our treatments on a compassionate basis since large numbers of patients are not responding to existing treatments."
The company's efforts have previously focused on respiratory, skin, and vaginal infections, with prosthetic joint infections now added to their therapeutic portfolio. Precisio believes their engineered lysins will be effective against both gram-positive and gram-negative bacteria.
Manufacturing and Global Access
Engel highlighted the potential for global impact, stating that the company's efficiency in developing lysins will enable production in highly stable formulations with low cost-of-goods, making them available to both developed markets and low- and middle-income countries. This approach presents an opportunity to dramatically change health outcomes around the globe.
The clinical-stage biotech company, based in Dover, Delaware, operates as a platform-plus-product company with additional R&D operations in India, China, and the UK. Recent achievements include a grant award from the Gates Foundation for developing lysins to treat bacterial vaginosis and regulatory approval of a topical lysin in the European Union.
