Caliway Reports Positive Phase 2 Results for Dercum’s Disease Treatment

In the CBL-0202DD study, patients treated with CBL-514 reported a mean pain-score reduction of 3.1 points at Week 20, outperforming the 1.9-point reduction observed in the placebo group. The efficacy of the treatment proved durable, with pain scores continuing to improve through Week 24. Notably, an exploratory analysis revealed that 90% of participants achieved a meaningful reduction of at least 3 points across the majority of their treated lipomas.

The drug, a small-molecule injection designed to induce adipocyte apoptosis, was well-tolerated by participants. Investigators reported no serious adverse events related to the medication, with only mild-to-moderate injection-site reactions noted. These findings are particularly significant given that Dercum’s Disease, which involves the accumulation of painful adipose masses, has historically relied on surgical interventions that offer only temporary relief.

Caliway is now looking beyond this rare disorder, identifying Lipedema as a strategic expansion target. With Lipedema affecting an estimated 10% of women globally, the company sees a potential market opportunity exceeding US$30 billion. Leveraging the positive data from the Dercum’s study, the firm intends to consult with clinical experts to map out a development strategy for this larger patient population, aiming to address significant unmet medical needs in adipose tissue disorders.