Dover, DE — Precisio Biotix Therapeutics said it has treated a patient with a chronic, multidrug-resistant prosthetic joint infection using its staph lysin ClyO, also known as LYSG101, under an FDA-approved expanded-access protocol.
The company said dosing began June 1 under an expanded-access investigational new drug application. The treatment follows a four-month protocol with at least six months of follow-up.
Precisio said the program will track safety, improvements in clinical signs and symptoms, and whether the infection is durably eradicated or sustainably suppressed. The company said the patient had not achieved those outcomes over the past seven years despite multiple standard-of-care surgeries and long-term antibiotic suppression therapy.
After more than one month of treatment with ClyO, Precisio said dosing has been safe and well tolerated, with no adverse events. The company said it is too early to fully assess efficacy, but the patient’s previously infected knee joint remains culture-negative, meaning no bacteria have been detected.
Lysins are enzyme-based antimicrobials being developed as an alternative approach to treating infections, including those involving antibiotic-resistant bacteria and biofilms. Prosthetic joint infections, especially those caused by methicillin-resistant Staph bacteria, can be difficult to treat and may require repeated surgery, long-term antibiotics and chronic pain management.
“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,” said Dr. Raymond Schuch, VP, Director of US Operations. “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 rising numbers of knee and hip replacements are contributing to an increase in prosthetic joint infections.
“Knee and hip replacements are soaring in the US and globally, bringing with them an increasing incidence of prosthetic joint infections,” Engel said. “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.”
Engel said the company’s engineered lysins are being developed to treat and prevent gram-positive and gram-negative infections and could be produced in stable formulations at a low cost of goods.
“The engineered lysins we are developing, that do not cause antibiotic resistance, will have a tremendous impact,” Engel said. “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.”
