Caliway Biopharmaceuticals (Caliway) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the investigation of CBL-514 in Dercum's disease treatment. CBL-514 is a lipolysis injection that can reduce local subcutaneous fat by selectively inducing adipocyte apoptosis, and is the first drug to receive Fast Track designation for Dercum's Disease treatment. The FDA's decision was based on Caliway's preclinical and CBL-0201DD Phase 2 (NCT05387733) clinical study results, showing that CBL-514 is the first and only product to demonstrate clinically meaningful and statistically significant in painful lipomas complete clearance or dimensions reduction of more than 50%, as well as significant pain improvement by 4.7 points.

Therefore, the CBL-0201DD phase 2 study demonstrated the substantial improvement over available therapies to address the unmet medical need for Dercum's disease. The Expanded Access Program is a program recognized by the FDA as a follow-on to their Fast Track Designation. An EAP provides a potential pathway for patients with a serious or life-threatening condition to gain access to an investigational drug for treatment outside of a clinical trial, particularly when no comparable or satisfactory alternative therapy options are available.

For physicians that have identified a patient, or have spoken to a patient who contacted contact Caliway at .Caliway's goal is to acknowledge receipt to the requesting physician within (10-12) business days. Dercum's disease is a rare disorder that is characterized by the development of painful lipomas primarily located on the trunk region, and the extremities close to the trunk. The pain is chronic (>3 months), symmetrical, often disabling, and resistant to traditional analgesics.

The main symptoms of Dercum's disease, according to the early reports, are obesity, pain from the lipomas, and numerous psychiatric manifestations, including sleep disturbances, depression, and anxiety. The etiology of Dercum's disease remains unknown. There is no approved drug nor recommended standard treatment for Dercum's disease yet.

The current treatment options, including surgical removal, liposuction, therapy, and inflammation inhibitors, are symptomatic, and the efficacies are limited with numerous adverse events. The clinical need for Dercum's Disease remains unmet. According to the Global Dercum's Disease Market Research Report, the global Dercum's disease treatment market size in 2021 was $11.3 billion.

With a compound annual growth rate (CAGR) of 6.76%, the global market of Dercum's disease treatment in 2030 is estimated to expand to $19.95 billion. CBL-514, a potentially first-in-class small-molecule drug, is an injection lipolysis drug, is an injection liplysis drug, is an injection Lipolysis drug that can reduce local subcutaneously fat by selectively inducing adipocyte cell apoptosis, and is the most common drug that is a rare disease characterized by the growth of painful lipomas, the pain of painful lipomas, and the pain is chronic (CAGR), symmetrical, often disabling and resistant to traditional analgesics, and resistant to traditional analgesic. The main symptoms of Dercum's disease, according to the early reports, are obesity, pain from the lipomas, and numerous psychiatric manifestations, including sleep disturbances, depression, and anxiety.

The etiology of Dercum's disease remains unknown. There is no approved drug nor recommended standard treatment for Dercum's disease yet. The current treatment options, including surgical removal, liposuction, electrotherapy, and inflammation inhibitors, are symptomatic, and the efficacies are limited with numerous adverse events.

The clinical need for Dercum's disease remains unmet.