PITTSBURGH--(BUSINESS WIRE)--Peptilogics, a biotech company that engineers peptide therapeutics to radically improve the treatment landscape for patients with life threatening diseases, today presented Phase 1 safety and tolerability data on PLG0206, a unique engineered antibacterial peptide being developed for the treatment of prosthetic joint infection (PJI). The first-in-human trial showed that PLG0206 intravenously administered was well tolerated in healthy volunteers, with linear PK over the dose range. Data were presented at IDWeek 2021.
“The safety, tolerability, and pharmacokinetics observed in this Phase 1 study of PLG0206 intravenously administered is an important milestone for Peptilogics as we come one step closer to providing this potential treatment to PJI patients and the orthopedic and infectious disease communities,” said Jonathan Steckbeck, Ph.D., Founder and CEO of Peptilogics. “With broad-spectrum activity including multidrug resistant pathogens, low rates of resistance, and a favorable safety profile, PLG0206 exemplifies the potential of designing peptide therapeutics for purpose, broadly targeting the biofilm and the persistent pathogens that make PJI so difficult to treat.”
PLG0206 is an investigational, potent, broad-spectrum antibacterial peptide that has been granted FDA Orphan Drug Designation and Qualified Infectious Disease Product Designation for the treatment of PJI. The Phase 1 study enrolled 47 subjects across 6 cohorts of 8 participants receiving escalating single IV infusions of PLG0206 1 mg/kg dose or placebo. Eight participants per cohort were randomized 3:1 to receive either PLG0206 (6 per cohort) or placebo (2 per cohort). Serial pharmacokinetic samples were taken prior to infusion and up to 48 hours post infusion. Safety and tolerability were assessed throughout the study.
“The systemic safety and tolerability data from our first-in-human trial of PLG0206 intravenously administered are highly encouraging and will inform dosing regimens in future studies of PLG0206 in PJI and other indications,” said David Huang, M.D., Ph.D., and Chief Medical Officer of Peptilogics. “We remain on track to initiate a first-in-patient clinical study for the treatment of PJI in the first quarter of 2022.”
Peptilogics presented data from three posters at IDWeek 2021:
A Phase 1 Safety and Tolerability of Single Ascending Doses of a Novel Engineered Cationic Peptide, PLG0206, in Healthy Subjects (Poster #1070720)
- IV infusions of PLG0206 were well tolerated over a range of 0.05 to 1 mg/kg and showed linear PK.
- Most adverse events were mild and similar to the placebo group.
- Therapeutic exposures were achieved at 1 mg/kg and the median terminal half-life suggests once-daily dosing.
Knee explant analysis (KnEA) using PLG0206 in periprosthetic joint infection (KnEA Study) (Poster #1070556)
- 21 infected prosthetics, from patients with chronic periprosthetic joint infections, exposed to PLG0206 1 mg/mL concentration demonstrated a mean 4log10 reduction (range 2 to 7) in bacterial counts.
In vitro activity of PLG0206 against isolates commonly found in periprosthetic joint infections (Poster #1070530)
- PLG0206 was found to have potent antimicrobial activity against coagulase negative staphylococci, E. coli, E. cloacae, C. freundii, P. aeruginosa and A. baumannii, regardless of antibiotic drug resistance phenotypes.
The presentations of Phase 1 results and Peptilogics research can be viewed on-demand by conference attendees through IDWeek’s Interactive Program.
About Prosthetic Joint Infection (PJI)
More than 1 million total joint replacements are performed annually in the U.S., a number that is expected to grow to 4 million annual procedures by 2030 due to an aging and growing population. Following joint replacement, 1-2% of patients will develop a PJI, a serious life-threatening condition which often necessitates a major surgical procedure to resolve the infection. These additional follow-on surgeries carry a 60 percent failure rate and result in substantial numbers of patient deaths, evidenced by a 25% 5-year mortality rate.
PLG0206 is an investigational broad-spectrum, anti-infective which has been granted FDA Orphan Drug Designation for its evaluation for the treatment of PJIs. Engineered with intention and purpose, PLG0206 has a unique mechanism of action that directly addresses the biofilm bacteria and persistent pathogens that can evade conventional antibiotics, targeting and disrupting bacterial membranes to trigger bacterial cell death. PLG0206 has demonstrated best-in-class, rapid, broad-spectrum activity against a variety of pathogens, regardless of resistance phenotype, identified by the World Health Organization and the Centers for Disease Control as critical, urgent, or high priority targets.
Peptilogics engineers peptide therapeutics 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 Thiel Capital, Presight Capital, CARB-X, and Founders Fund. For more information about Peptilogics, visit www.peptilogics.com or follow the company on Twitter and LinkedIn.
This research is supported by Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X). CARB-X funding for this research is supported by the Cooperative Agreement Number IDSEP160030 from ASPR/BARDA and by an award from the Wellcome Trust. The contents are solely the responsibility of the authors and do not necessarily represent the official views of the HHS Office of the Assistant Secretary for Preparedness and Response, or other CARB-X funders.