Kira Pharmaceuticals, a global biotechnology company pioneering a new generation of complement-targeted therapies to treat immune-mediated diseases, announced that the first healthy volunteer has been successfully dosed in a first-in-human Phase 1 clinical trial for its lead investigational therapy P014. This randomized, double blind, placebo-controlled study will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of escalating single and multiple doses of P014.  These data will guide dose selection as well as provide essential supportive information for the design of trials for patients living with complement-mediated diseases.   

P014 is a bi-functional, first-in-class biologic with a unique mechanism of action. Designed to block two separate rate-limiting steps in the complement activation cascade critical for disease development, P014 provides a powerful and selective approach to inhibit the complement system. P014 has also been engineered to have an extended half-life and potency, with the opportunity for subcutaneous administration at home by the patient.

"Today marks a pivotal milestone for Kira Pharmaceuticals as we transition into a clinical stage company," said Frederick Beddingfield, MD, PhD, CEO at Kira Pharmaceuticals. "The data generated from this Phase 1 study will provide important information about P014's safety and tolerability profile as well as biomarkers and ex-vivo surrogate measurements of drug efficacy data that will inform our understanding of how the drug is impacting target biology. These data will be invaluable as we consider P014 for treatment of a range of complement-mediated diseases."

Founded by some of the foremost experts in complement biology, Kira Pharmaceuticals has designed its LOGIC drug discovery platform (Lead identification, Optimization and attribute Generation, In vivo Confirmation) to overcome the inherent challenges of complement drug discovery. The complement system is a key driver and amplifier of inflammation and tissue damage in many human diseases but is complex and has been historically difficult to target. Kira's LOGIC platform improves target selection and validation and the design and development of therapies with superior efficacy and longer lasting inhibition.  

About Kira Pharmaceuticals

Kira Pharmaceuticals is a clinical stage biotechnology company developing complement-targeted therapies to treat immune-mediated diseases. Enabled by its LOGIC drug discovery platform, the company is committed to advancing first-in-class and best-in-class therapies to transform the lives of patients with complement-driven diseases. With offices in Cambridge, Massachusetts and an R&D center in Suzhou, China, Kira Pharmaceuticals is committed to establishing a global footprint and advancing life-changing therapies to patients around the world.