Peptilogics Announces First Patient Dosed in Phase 1b Study of PLG0206 for Periprosthetic Joint Infection

PITTSBURGH–(BUSINESS WIRE)–Peptilogics, a clinical stage biotech company engineering peptide therapeutic solutions for patients with life-threatening diseases, today announced it has dosed its first patient with PLG0206 in the LOGIC-1 trial for the treatment of periprosthetic joint infections (PJI) occurring after a total knee arthroplasty (TKA). PLG0206 was designed with a unique mechanism of action intended to directly address persistent bacterial pathogens within the biofilm that evade standard of care antibiotics. PLG0206, an investigational product, has been granted FDA Orphan Drug, Fast Track and Qualified Infectious Disease Product (QIDP) Designations for the treatment of PJI.

“We are pleased with the dosing of the first patient in the Phase 1b study of our lead peptide candidate, PLG0206, which we believe has the potential improve clinical outcomes for patients suffering and dying from PJIs after a joint replacement. We believe PLG0206 has the potential to change the treatment paradigm for PJI,” said David Huang, M.D., Ph.D, Chief Medical Officer of Peptilogics.

Matthew Dietz, M.D., Coordinating Investigator for the study, WVU Medicine Orthopaedic Surgeon, and Associate Professor at the WVU School of Medicine, and his team were the first in the country to provide a patient PLG0206 in the clinical treatment setting of prosthetic joint infection. “We are excited to help advance the care of patients who have been diagnosed with prosthetic joint infection. The use of PLG0206, the engineered antimicrobial peptide, allows us to hopefully retain hip and knee replacements while effectively treating the patient’s infection. This is a big step in finding a solution that has plagued the orthopedic community for years.”

Each year, close to three million total joint replacements are performed in the U.S., a number that is expected to significantly increase by 2030 due to an aging and active population. Following joint replacement, the most devastating complication a patient can face is contracting a PJI, a serious life-threatening condition, which often necessitates continuous antibiotic usage, multiple high-risk surgical procedures, and implant removal with limited ability to resolve the infection. The current standard of care has up to a 60% failure rate at 4 years and a 25% five-year mortality rate. Given the high unmet need, Peptilogics is working to shift the treatment paradigm, differentiating PLG0206 from current therapeutic options.

“As we continue to reimagine the future of peptide therapeutic discovery, it is incredibly promising to have reached this milestone with our first program,” said Jonathan Steckbeck, Ph.D., Founder and CEO of Peptilogics. “PLG0206 has demonstrated potential best-in-class, rapidly bactericidal, broad-spectrum activity against a variety of biofilm pathogens in both in vitro and non-clinical studies, and safety in a previously completed Phase 1 study in healthy volunteers. Now we have the opportunity to determine its impact on patients with PJI, who have limited and often ineffective treatment options. I am excited for the precedent this sets for future programs to follow.”

LOGIC-1 is a Phase 1b open-label, dose-escalating study in people undergoing a debridement, antibiotics, and implant retention (DAIR) surgical procedure for the treatment of PJI occurring after total knee arthroplasty (TKA). For additional information about the trial, please visit www.clinicaltrials.gov using the study identifier NCT05137314.

About PLG0206

PLG0206 is an investigational, broad-spectrum, non-traditional antibiotic peptide therapeutic currently in Phase 1b clinical development for the treatment of periprosthetic joint infection (PJI). PLG0206 has the potential to rapidly target bacteria and persistent pathogens that produce biofilm and evade conventional antibiotics. It was engineered with a unique mechanism of action to target and disrupt bacterial cell membranes, without causing lysis or targeting human cell membranes at therapeutic doses, thereby reducing the potential for inflammation and cytotoxicity. In both in vitro and non-clinical studies, PLG0206 has demonstrated potent activity against both Gram positive and Gram negative antibiotic resistant bacteria with a low risk of developing resistance to PLG0206. Development plans include franchise expansion to three indications across global markets. PLG0206 has been granted FDA Orphan Drug designation and Fast Track designation for the treatment of PJI and has also been designated as a Qualified Infectious Disease Product (QIDP).

About Periprosthetic Joint Infection (PJI)

Joint replacement is the most common operative procedure with seven million hip and knee replacements anticipated globally in 2030. PJI is the most common complication of joint replacement surgery and, if diagnosed with PJI, patients currently require an average of three surgeries to treat. With up to 60% recurrence and a five-year mortality of 25% associated with this condition, PJI is a catastrophic and growing problem with no effective therapeutic solution. The disease also leads to a substantial economic burden, where in the U.S. the average per patient cost is significant to treat PJI, making this a major challenge for hospitals and payers alike.

About Peptilogics

Peptilogics engineers peptide therapeutic candidates to radically improve the treatment landscape for patients with life-threatening diseases. Through biological and pharmaceutical expertise, novel artificial intelligence algorithms, and purpose-built super-computing, Peptilogics is advancing an extensive therapeutic pipeline and accelerating discovery efforts at a pace and scale that was previously impossible. Peptilogics is backed by visionary investors in life science and technology including Peter Thiel, Presight Capital, Founders Fund, CARB-X, and Cystic Fibrosis Foundation. For more information about Peptilogics, visit www.peptilogics.com.

Disclaimer:

Research reported in this press release is supported by CARB-X. CARB-X’s funding for this project is provided by Federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority; Antibacterials Branch under agreement number: 75A50122C00028, and by an award from Wellcome (WT224842). The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views of CARB-X or any of its funders.

Contacts

Media Contact:
Liz Boten

SVP Communications, Evoke Canale

Email: [email protected]

Peptilogics Contact:
Jodie Gillon

SVP Corporate Affairs & Patient Advocacy

Email: [email protected]