Caliway Announces U.S. FDA IND Clearance for CBL-0302, Its Second Global Pivotal Phase 3 Study of CBL-514

Asia-Pacific Phase 2 Study CBL-0206 Also Approved by Australia HREC and Taiwan TFDA, Accelerating Global Dual-Track Strategy

• U.S. FDA Clearance: The Investigational New Drug (IND) application for CBL-0302 (SUPREME-02), Caliway's second multi-country pivotal Phase 3 study for its localized fat reduction candidate CBL-514, has successfully passed the FDA's 30-day review period.
• Enrollment Imminent: Both global pivotal Phase 3 studies, CBL-0301 and CBL-0302, are expected to begin patient enrollment shortly, with topline results anticipated in 2027 to support a future New Drug Application (NDA).
• Asia-Pacific Expansion: Taiwan's TFDA and Australia's HREC have approved CBL-0206, an Asia-Pacific Phase 2 study of CBL-514, further bolstering Caliway's "global and regional parallel" development strategy.
• Robust Regulatory Pathway: Parallel advancement of global Phase 3 studies and Asia-Pacific trials aims to solidify CBL-514's regulatory foundation and maximize its long-term commercial potential worldwide.

NEW TAIPEI CITY, May 22, 2026 /PRNewswire/ -- Caliway Biopharmaceuticals (TWSE: 6919), a clinical-stage biopharmaceutical company advancing innovative small-molecule therapies for aesthetic medicine and metabolic diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for CBL-0302 (SUPREME-02). As the second multi-country pivotal Phase 3 clinical study of CBL-514—a first-in-class drug candidate for the reduction of abdominal subcutaneous fat—the IND passed the 30-day review period on May 18.

Caliway plans to initiate both global pivotal Phase 3 studies, CBL-0301 and CBL-0302, in the near term, anticipating clinical results in 2027. CBL-0302 utilizes a randomized, double-blind, placebo-controlled design and expected to enroll approximately 320 participants across the United States, Canada, and Australia to evaluate the efficacy, safety, and tolerability of the CBL-514 injection. Clinical study applications for CBL-0302 have also been submitted to Health Canada and Australia.

The primary efficacy endpoints of CBL-0302 are uniquely rigorous, comprising (1) abdominal subcutaneous fat volume change as measured objectively by MRI, and (2) abdominal fat level improvement assessed by the Patient-Reported Abdominal Fat Rating Scale (PR-AFRS). These endpoints and the study's design are strongly supported by Caliway's previously completed Phase 2b clinical studies, CBL-0204 and CBL-0205, which successfully met all primary endpoints.

Establishing a New Standard in Aesthetic Medicine
By including objective MRI measurements of fat volume change as a primary efficacy endpoint, CBL-514 differentiates itself from the current aesthetic market, where existing drugs and devices are typically approved based primarily on subjective "Improvement in Appearance" claims. This quantifiable approach to fat reduction data is expected to significantly strengthen CBL-514's product positioning, medical value, and global market competitiveness.

Accelerating Asia-Pacific Clinical Strategy
In parallel with the global pivotal Phase 3 program, Caliway continues to aggressively advance its regional clinical strategy. On May 19, the Taiwan Food and Drug Administration (TFDA) approved CBL-0206, an Asia-Pacific Phase 2 study of CBL-514. The study previously received approval from Australia's Human Research Ethics Committee (HREC).

Expected to enroll approximately 250 participants in Taiwan and Australia, CBL-0206 utilizes a randomized, placebo-controlled, two-stage design. Stage 1 involves a 4:1 randomization (CBL-514 vs. placebo), while Stage 2 will provide CBL-514 treatment to all participants. Efficacy assessments align with the global strategy, utilizing MRI for fat volume change and AFRS for fat level improvement.

Expanding beyond the predominantly Western populations in previous trials, CBL-0206 will generate critical safety and efficacy data for Asian demographics. This will broaden the overall participant database and establish a comprehensive clinical foundation for future NDA submissions, regional market strategies, and international licensing collaborations.

Looking ahead, Caliway intends to submit a Phase 3 clinical study application for CBL-0304 in China during the second half of 2026. Through this dual-track strategy, Caliway aims to deepen CBL-514's global regulatory footprint and commercialization readiness.

About CBL-514
CBL-514, developed by Caliway, is a first-in-class 505(b)(1) small-molecule injectable lipolysis drug. It is the world's first localized fat reduction therapy designed to induce adipocyte apoptosis without systemic safety risks, demonstrating an excellent tolerability profile. To date, 10 clinical trials involving 544 subjects have been completed, meeting all efficacy and safety endpoints. CBL-514 is currently in development for multiple indications, including non-surgical localized fat reduction and moderate-to-severe cellulite. A differently formulated counterpart, CBL-514D, is being studied for additional indications such as Dercum's disease.

About Caliway Biopharmaceuticals
Caliway Biopharmaceuticals (TWSE: 6919) is a clinical-stage biopharmaceutical company driven by the discovery and development of breakthrough novel small-molecule therapeutics. Caliway aims to become an innovative pharmaceutical leader in aesthetic medicine and other diseases with significant unmet medical needs. For more information, please visit: https://www.caliwaybiopharma.com/en/ 

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