Switzerland-based Covagen has started a Phase Ib/IIa study of COVA322, the company’s lead bispecific FynomAb developed for the treatment of patients with rheumatoid arthritis, psoriatic arthritis and other inflammatory diseases.
COVA322 is claimed to be first of the company’s bispecific FynomAbs to enter clinical trials.
Phase Ib/IIa study is a randomized, placebo-controlled study designed to evaluate the safety, tolerability and pharmacokinetics of a single ascending dose of COVA322.
The multi-centre, double-blind study will enrol 39 psoriasis patients in Germany. Enrolment in the trial and dosing of COVA322 has begun for the first cohort of patients.
Secondary endpoints of the study include readouts on psoriatic skin lesions as well as biological responses measured in skin biopsies.
Covagen chief development officer Dr Mathias Locher said that with COVA322, the company has moved its first proprietary FynomAb into the clinic.
"COVA322 has a novel mechanism of action by simultaneously inhibiting both TNF and IL-17A," Dr Locher said. "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."
Covagen CEO Dr Julian Bertschinger noted that the company believes 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 its proprietary bispecific FynomAb platform.
"We expect to have top-line data in the first quarter of 2015," Dr Bertschinger said.
In December 2013 and February 2014, Covagen closed a Series B financing round with a total of CHF45m that primarily supports Phase I and Phase II developments of its COVA322.
Image: Magnetic resonance images of fingers in psoriatic arthritis. Photo: courtesy of Stevenfruitsmaak.