Precisio Biotix Therapeutics, Inc. (Precisio) Announces the Use of Its ClyO (Staph Lysin) to Treat a Multi Drug-Resistant Prosthetic Joint Infection (PJI) Under an Expanded Access Chronic Care Management Protocol

• Lysins are a promising new family of enzyme-based antimicrobials which offer unique properties compared to antibiotics
• Orthopedic infections, especially those caused by methicillin-resistant Staph bacteria, are increasingly problematic because of biofilms and antibiotic resistance, requiring drastic surgical interventions and often resulting in long-term chronic pain and disability
• Precisio’s lysin-based solutions can provide both novel treatments and chronic care, importantly without causing antibiotic resistance – often without surgery

DOVER, Del.--(BUSINESS WIRE)--Precisio announced the continuation of its expanded access program, with dosing of a staph lysin called ClyO (LYSG101) to a patient with chronic prosthetic joint infection. Under an FDA-approved expanded-access IND, administration of ClyO was initiated on June 1. The treatment follows a 4 month protocol with a minimum 6 month follow-up. Outcomes to be tracked include safety, improvements of clinical signs and symptoms, and either durable eradication or sustained suppression of infection. For this patient, these outcomes were not achievable over the last 7 years, through multiple standard-of-care surgical procedures and long-term antibiotic suppression therapies. After 1 plus months of treatment with ClyO, the dosing has been safe and well-tolerated with no adverse events. While it is too early to fully assess efficacy, the patient’s previously infected knee joint remains culture-negative (i.e., no bacteria detected).

Dr. Raymond Schuch, VP, Director of US Operations, notes “Precisio’s ability to discover and then uniquely engineer potent lysins for human medicinal use without causing resistance, places us at the forefront of a revolution in precision antimicrobial therapies to target infections and diseases in which antibiotics fail and alternatives are diminishing. The Precisio team brings together unique backgrounds in protein engineering, lysin microbiology and drug development to address this problem, with ClyO a lead compound and with multiple others following. The expansion of our compassionate care program with ClyO under a chronic care management format brings us another exciting step toward helping people with life-altering infections.”

Mark Engel, Founder and CEO of Precisio said “Knee and hip replacements are soaring in the US and globally, bringing with them an increasing incidence of prosthetic joint infections. These infections, particularly those caused by Staph organisms, devastate patient forcing them to face prolonged antibiotic courses, repeat surgeries, and rising costs. ClyO brings a fundamentally different approach, killing bacteria regardless of antibiotic resistance or biofilms. Under chronic care management, lysins offer the possibility of cure or at worst long-term suppression. We believe that patients who receive our treatment will be able to live a normal life. And, as an additional benefit, our treatments will result in savings to hospital systems.”

Overall, Mr. Engel summarizes that “ The engineered lysins we are developing, that do not cause antibiotic resistance, will have a tremendous impact. Our lysins will be effective at treating and preventing infections, both gram-positive and gram-negative. Because we are so efficient in developing them, we will be able to produce these lysins in highly stable formulations with a low cost-of-goods, thereby making them available to both developed markets and in the LMIC markets. Our current pipeline addresses about $55 billion in unmet medical needs. This presents an opportunity to dramatically change health outcomes associated with infections around the globe. We are now seeking both strategic and financial support to more rapidly move forward.”

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, vaginal, 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.