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Endevica Bio Announces First Patient Dosing in Phase 2 Trial in Patients with Stage 4 Metastatic Colorectal Cancer

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Endevica Bio Announces First Patient Dosing in Phase 2 Trial in Patients with Stage 4 Metastatic Colorectal Cancer

Endevica Bio Announces First Patient Dosing in Phase 2 Trial in Patients with Stage 4 Metastatic Colorectal Cancer

Apr 17, 2025

NORTHBROOK, Ill., April 17, 2025 /PRNewswire/ -- Endevica Bio, a privately held company developing first-in-class peptide drug candidates, announced today the dose administration for the first patient in a Phase 2 trial for its experimental drug TCMCB07 (B07) to prevent weight loss in cancer patients undergoing chemotherapy.

The trial, being conducted in partnership with WuXi Clinical, will include 20 sites and 100 patients who are diagnosed with stage 4 metastatic colorectal cancer.

In the trial, patients are dosed with B07 as they begin chemotherapy and during the first several rounds of chemotherapy. The primary endpoint is preventing weight loss, which can lead to a debilitating condition called cachexia, a life-threatening wasting syndrome associated with chronic diseases, including cancer.

"This marks an important milestone in our commitment in developing a potentially life changing treatment for cachexia," said Russell Potterfield, Chief Executive Officer and Executive Chair of Endevica. "Each trial brings us closer to offering a viable solution for this debilitating disease, and we remain dedicated to making a lasting impact on the lives of those affected."

"We are incredibly excited to have our first patient dosed with B07 in individuals diagnosed with metastatic colorectal cancer who are undergoing chemotherapy," said Dr. Daniel Marks, Chief Medical and Scientific Officer of Endevica Bio. "Since there is no FDA approved therapeutic for cancer cachexia, this trial is a crucial step to provide a therapy for an area of huge unmet clinical need, and we look forward to the results."

In 2024, Endevica Bio completed its Phase 1 clinical trial with preliminary findings supporting its strong safety and efficacy. Last November, the Journal of Clinical Investigation, showed that B07 improved the appetite and preserved lean mass and fat mass in rodent models of cancer and its associated combination chemotherapy. This same study showed the strong potential of B07 to alleviate chemotherapy-induced anorexia and weight loss for millions of patients worldwide.

About TCMCB07
TCMCB07 is a melanocortin‐3/4 antagonist peptide candidate in clinical development for the treatment of cachexia. It is designed to be a first-in-class peptide drug with the ability to cross the blood-brain barrier and act on previously inaccessible target receptors to modulate the body's behavioral and metabolic response to chronic illness. Pre-clinical animal trial results show significant lean muscle mass retention (e.g., a reversal of the cachectic condition) during administration of the drug. The results are consistent in cachexia arising from many different types of chronic disease.

About Endevica Bio
Endevica Bio creates first-in-class peptide drug candidates. Endevica Bio's technology platform, protected by a family of patents and pending applications, allows for the modification of peptides to modulate activity of important drug targets behind the blood-brain barrier.

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