Covagen today announced it has initiated a Phase Ib/IIa study with COVA322, a bispecific TNF/IL-17A inhibitor. COVA322 is Covagen's lead bispecific FynomAb® developed for treatment of patients with rheumatoid arthritis, psoriatic arthritis and other inflammatory diseases. The trial will enroll 39 patients with psoriasis and evaluate safety as well as biological activity of COVA322. Enrollment in the trial and dosing of COVA322 has begun for the first cohort of patients.
"With COVA322, Covagen has moved its first proprietary FynomAb into the clinic," said Mathias Locher, Ph.D., chief development officer of Covagen. "COVA322 has a novel mechanism of action by simultaneously inhibiting both TNF and IL-17A. This dual inhibition has the potential to result in superior efficacy compared to current treatment options for rheumatoid arthritis, psoriatic arthritis and other inflammatory diseases."
Julian Bertschinger, Ph.D., chief executive officer of Covagen added: "We believe this first clinical study with COVA322 in psoriasis patients may indicate its significant potential to improve the treatment of inflammatory diseases and help to validate the capabilities of our proprietary bispecific FynomAb platform. We expect to have top-line data in the first quarter of 2015."
The primary aim of the Phase Ib/IIa trial is to evaluate the safety, tolerability and pharmacokinetics of a single ascending dose of COVA322. The randomized, double-blind, placebo-controlled, multi-center study will be conducted in Germany in 39 patients with psoriasis. Secondary endpoints include readouts on psoriatic skin lesions as well as biological responses measured in skin biopsies.