DOVER, Del.: Precisio announced a first-in-man dosing of its staph lysin called ClyO (LYSG101) to a patient with a prosthetic joint infection that had not responded to other treatments. The FDA approved this treatment under a compassionate care IND filed by Mayo Clinic. The patient appears to have tolerated the treatment without any adverse events. It is too early to assess full efficacy, but this is certainly a significant step toward providing additional options to patients, particularly when traditional treatments have failed.

Dr. Raymond Schuch, VP, Director of US Operations, notes, “Our sole company 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. Our team possesses unique experience of developing these lysins and transitioning lysins into clinical studies and into patients. To date, our efforts have focused on respiratory, skin, and vaginal infections. We are excited to add prosthetic joint infections to the portfolio of infections we think that we can effectively treat.”

Mark Engel, Founder and CEO of Precisio said, “We are a platforms plus products company. The key to developing best-in-world lysins is that we use multiple self-developed high-tech proprietary tools. These include tools in bioinformatics, machine-learning, and AI (Zeus™-LysiThru™). We are now at a point where we think we 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. 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.”

Dr. Assaf Raz, VP of Research and Development noted: “Drug-resistant infections are a pressing global health issue, causing 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. 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.”

Mr. Engel summarizes that, “The engineered lysins we are developing will have a tremendous impact as additional tool for treating and preventing infections. We think that our lysins will be effective against both gram-positive and gram-negative bacteria. Because we are so efficient in developing them, we will be able to produce our lysins in highly stable formulations with low cost-of-goods, thereby making them available to both developed markets and in the LMIC markets. This presents an opportunity to dramatically change health outcomes around the globe. We are now seeking both strategic and financial support to move forward more rapidly. Our team is highly motivated since we know that every day wasted means lives lost.”

About Lysins: Lysins are members of a promising new class of antimicrobials - direct lytic agents. Unlike traditional antibiotics, lysins actively hydrolyze the bacterial cell wall, causing extremely rapid lysis and cell death. Due to this unique mechanism of action, lysins are targeted to specific pathogens, can effectively degrade biofilms, and are effective against bacteria resistant to traditional antibiotics. Critically, unlike traditional antibiotics, they do not cause bacterial resistance.

About Precisio Biotix Therapeutics Inc. (https://www.precisiobiotix.com): Precisio is a US clinical stage biotech company creating lower-cost novel precision engineered biological antibacterials, with an initial focus on respiratory, skin, lung, and prosthetic joint infections. Precisio is a platform-plus-product company (Rx and consumer). The Company has additional R&D operations in India, China, and the UK. Management has had multiple previous successful exits and currently seeks strategic partners for all aspects of the business. Recent news includes (1) a grant award from the Gates Foundation for the development of lysins to treat Bacterial Vaginosis and (2) regulatory approval of a topical Lysin in the EU.

Fonte: Business Wire