Precisio Biotix Therapeutics Inc. has marked a significant milestone with the first-in-man dosing of its staph lysin, ClyO (LYSG101), to a patient suffering from a prosthetic joint infection. This patient had previously shown no response to conventional treatments, highlighting the urgent need for alternative therapeutic approaches. The treatment was administered following approval under a compassionate care Investigational New Drug (IND) application, filed by Mayo Clinic. Early reports indicate that the patient tolerated the treatment well, experiencing no adverse events, though full efficacy assessment is still underway. This initial success represents a crucial step forward in expanding treatment options, particularly for patients whose conditions are refractory to traditional methods.

Dr. Raymond Schuch, VP and Director of US Operations at Precisio, emphasized the company's core mission: the systematic engineering of native lysins to create optimized, drug-like solutions against antimicrobial-resistant human pathogens. These pathogens are associated with significant unmet medical needs. Dr. Schuch noted the team's unique expertise in developing and transitioning lysins from research into clinical studies and ultimately into patient care. While previous efforts concentrated on respiratory, skin, and vaginal infections, the successful administration of ClyO to a patient with a prosthetic joint infection expands the scope of infections Precisio believes it can effectively treat.

Mark Engel, Founder and CEO of Precisio, described the company as a "platforms plus products" entity. He highlighted the critical role of proprietary, high-tech tools—including advanced bioinformatics, machine-learning, and AI platforms such as Zeus™-LysiThru™—in developing what he describes as "best-in-world lysins." These advanced technologies enable Precisio to develop lysin products capable of combating a wide range of infections, including those that are resistant to standard antibiotics. Engel expressed optimism about future announcements, stating that this initial patient at Mayo Clinic is expected to be the first of many examples to be shared in the coming months, responding to a global demand from doctors for compassionate use treatments.

The urgency of Precisio's work is underscored by the global health crisis of drug-resistant infections. Dr. Assaf Raz, VP of Research and Development, cited alarming statistics from the UN Ad hoc Interagency Coordinating Group on Antimicrobial Resistance, noting that such infections currently cause at least 700,000 deaths annually, a figure projected to rise to 10 million by 2050 without decisive action. Precisio's research team is dedicated to developing new lysin therapeutics that circumvent antibiotic resistance, swiftly creating effective solutions for multidrug-resistant pathogens to improve patient outcomes and combat this growing threat.

Mr. Engel further articulated the broader impact of the engineered lysins. He believes they will serve as invaluable additional tools for both treating and preventing infections, effective against both gram-positive and gram-negative bacteria. The efficiency of Precisio's development process allows for the production of lysins in highly stable formulations with low cost-of-goods, making them accessible to both developed markets and low- and middle-income countries (LMIC). This global accessibility presents a profound opportunity to dramatically enhance health outcomes worldwide. Precisio is actively seeking strategic and financial support to accelerate its progress, driven by the knowledge that every day of delay could mean lives lost.

Lysins represent a promising new class of antimicrobials, known as direct lytic agents. Unlike traditional antibiotics, lysins function by actively hydrolyzing the bacterial cell wall, leading to extremely rapid lysis and cell death. This unique mechanism of action allows lysins to be highly targeted to specific pathogens, effectively degrade challenging bacterial biofilms, and remain effective against bacteria that have developed resistance to conventional antibiotics. Critically, and in stark contrast to traditional antibiotics, lysins do not induce bacterial resistance, offering a sustainable solution to the evolving challenge of antimicrobial resistance.

Precisio Biotix Therapeutics Inc. is a US-based clinical-stage biotechnology company focused on creating lower-cost, novel precision-engineered biological antibacterials. Its initial therapeutic areas include respiratory, skin, lung, and prosthetic joint infections. Operating as a platform-plus-product company (encompassing both Rx and consumer applications), Precisio maintains additional R&D operations across India, China, and the UK. The company's management team boasts a track record of multiple successful exits and is currently seeking strategic partners to advance various aspects of its business. Recent achievements for Precisio include a grant award from the Gates Foundation for the development of lysins targeting Bacterial Vaginosis and regulatory approval for a topical Lysin in the European Union.