Peptilogics Announces Successful Completion of Phase 1 Clinical Trial of PLG0206, a First-in-Class Anti-Infective Peptide Therapy

Study demonstrates safety and tolerability and favorable pharmacokinetics in healthy volunteers

PITTSBURGH, PA, USA I April 13, 2021 I Peptilogics, a biotechnology platform company leveraging computational design to discover novel peptide therapeutics, today announced the completion of a Phase 1 clinical trial for its lead compound PLG0206, a potent, broad-spectrum anti-infective that has been granted FDA Orphan Drug Designation and Qualified Infectious Disease Product Designation for its initial focus on the treatment of prosthetic joint infections (PJI). In the randomized, double-blinded, placebo-controlled trial, PLG0206 demonstrated a positive safety profile and favorable pharmacokinetics. The company plans to initiate a subsequent human proof of concept study evaluating PLG0206 in PJI patients this year.

"Completion of our first clinical study is an important milestone for the company, and we are highly encouraged by the data as they validate Peptilogics' approach to peptide design," said Jonathan Steckbeck, PhD, MBA, Founder and CEO of Peptilogics. "One of the challenges with systemic delivery of linear peptides is achieving a long half-life in the body without the use of modifications. When we designed PLG0206, we encoded this attribute into the peptide sequence itself. On a broader scale, our design approach has the potential to optimize drug discovery and development to more efficiently target areas of significant unmet medical need, beyond our start in PJIs."

PLG0206 has demonstrated best-in-class, rapid and broad-spectrum activity against pathogens identified by the World Health Organization and the Centers for Disease Control as critical, urgent, or high priority targets. Unlike existing antibiotics, PLG0206 directly addresses the biofilm and the persister pathogens that make PJI so difficult to treat and can be administered locally to the infected site, while maintaining a very low resistance profile.

"Prosthetic joint infections are extremely challenging to address and represent an area of high unmet need. Standard antibiotics fail to penetrate the infected joint space due to lack of blood supply to the infected joint as well as difficult to treat bacterial biofilms that resist standard treatments," said David Huang, MD, PhD, and CMO of Peptilogics. "Because of this, treatment failure rates can be as high as 40-50%, often resulting in additional surgery, amputation, or even death. Completion of Peptilogics' Phase 1 clinical trial for PLG0206, the first-in-human cationic antibiotic peptide, is an important step in bringing new treatments to the field of PJIs."

The design of PLG0206 served as the blueprint for Peptilogics' proprietary drug discovery platform that enables drug design for multiple desired objectives – safety, efficacy, synthesizability, and intellectual property, among others. Peptilogics' computational approach unlocks novel chemical space and reduces discovery cost and time, in contrast to existing technologies such as high throughput screening methods that suffer from high attrition rates and rely on screening of existing chemical libraries.

"Peptilogics' clinical data not only validates the translational strength of the company's internal anti-infectives pipeline, but also illustrates our drug design philosophy: that we can create remarkable peptide therapeutics by combining biology, artificial intelligence, and laboratory innovations to systematically understand and optimize their sequence and function," said Nicholas Nystrom, Peptilogics' SVP, Computation and Data.

About Prosthetic Joint Infections
Peptilogics' initial focus is on prosthetic joint infections (PJI), a rare life-threatening condition that may result from arthroplasty or joint replacement procedures. More than 1.4 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, patients who develop a PJI face a serious life-threatening condition with few to no effective treatment options available and often require major surgery to resolve the infection. High failure rates of current treatments are primarily due to the presence of biofilm bacteria which makes the eradication of the infecting pathogen extremely difficult.

About Peptilogics 
Peptilogics is a clinical-stage biotechnology platform that designs and develops novel peptide therapeutics. Through its computational platform, Peptilogics is advancing drug discovery to uncover new, previously unexplored chemical design space while ensuring biological viability and scalable manufacturing. Peptilogics' internal anti-infectives pipeline includes a novel clinical stage anti-infective, PLG0206, that has been granted FDA Orphan Drug Designation and Qualified Infectious Disease Product Designation for its initial focus on the treatment of prosthetic joint infections, an unmet medical need. More information on Peptilogics can be found at www.peptilogics.com as well as on Twitter and LinkedIn.

SOURCE: Peptilogics

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