New Taipei City – September 23, 2026 -- Caliway Biopharmaceuticals (TWSE: 6919) said on September 21 that its Phase 2 CBL-0202DD trial of CBL-514 met its primary efficacy endpoint, delivering statistically significant pain reduction in patients with Dercum's Disease compared with placebo, in both the Full Analysis Set (FAS) and Per-Protocol (PP) populations.
CBL-514 Cuts Pain Scores by 3.1 Points at Week 20 Versus Placebo
In the FAS population, patients treated with CBL-514 achieved a mean pain-score reduction of 3.1 points at Week 20, versus 1.9 points for placebo (p=0.005). In the PP population, the same 3.1-point reduction was measured against a 1.4-point placebo response (p=0.0002).
Secondary Endpoints Show Treatment Effect Increasing Through Week 24
At Weeks 16 and 24, FAS patients on CBL-514 recorded pain-score reductions of 3.5 and 4.1 points, respectively, versus 1.7 points for placebo at both time points (p=0.0017 and p0.0001). PP patients showed identical 3.5- and 4.1-point reductions against a 1.2-point placebo response (p=0.0001 and p0.0001). An exploratory analysis found roughly 90% of FAS patients achieved a clinically meaningful pain reduction of at least 3 points in more than half of their treated lipomas. No drug-related serious adverse events were reported; the most common side effects were mild-to-moderate injection-site reactions.
Dercum's Disease Market Projected to Reach $19.96 Billion by 2030
No approved therapies currently exist for Dercum's Disease, a rare disorder marked by painful lipomas that can persist beyond three months. Surgical removal, the primary current option, offers only temporary relief with undesirable side effects. Market research cited by Caliway estimates the global Dercum's Disease market at approximately $11.3 billion in 2021, growing to roughly $19.96 billion by 2030 at a 6.76% CAGR.
Caliway Targets Lipedema, a Market Opportunity Exceeding $30 Billion
Following the CBL-0202DD results, key opinion leaders and potential pharmaceutical partners have flagged CBL-514's potential in Lipedema, a chronic disorder affecting an estimated 10% of women globally and characterized by abnormal fat accumulation in the lower extremities. No curative therapies for Lipedema are currently approved, and weight loss alone does not resolve the underlying fat pathology. Caliway plans to work with clinical experts to evaluate a development strategy for CBL-514 in this indication. The drug is designed as a first-in-class, small-molecule 505(b)(1) injection that selectively induces adipocyte apoptosis. More than 544 subjects have participated in CBL-514 trials to date, with all primary and key secondary efficacy endpoints met across 10 completed studies with finalized statistical reports.