Calluna Pharma Launches Phase 2 Trial
Calluna Pharma is developing first-in class antibodies for inflammatory and fibrotic diseases and has just announced the launch of their Phase 2 AURORA Trial of the CAL101 asset. The AURORA study is enrolling patients across multiple sites around the world.
AURORA is a randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of CAL101 in patients with idiopathic pulmonary fibrosis (IPF).
The study aims to enroll 150 individuals with IPF across more than 50 sites, primarily in the US, UK, EU, Turkey and South Korea. After an initial 28-day screening period, patients will be randomized to receive seven monthly intravenous infusions of CAL101 or placebo at a randomization ratio of 3:2, respectively. The study’s primary endpoint is lung function, measured by forced vital capacity, or how much air can forcibly be exhaled, versus an individual’s baseline.