Endevica Bio to Start Phase 2 Clinical Trial of Drug to Prevent Weight Loss in Cancer Patients

A peptide called TCMCB07 will be administered to patients who are diagnosed with stage 4 metastatic colorectal cancer and will undergo chemotherapy.

NORTHBROOK, Ill., Dec. 20, 2024 /PRNewswire/ -- Endevica Bio, a privately held company developing first-in-class peptide drug candidates, today announced the start of a Phase 2 clinical trial of its experimental drug TCMCB07 (B07) to prevent weight loss in certain cancer patients undergoing chemotherapy.

The U.S. Food and Drug Administration recently authorized the trial, which will include 100 patients who are diagnosed with stage 4 metastatic colorectal cancer. B07 will be given to patients before they begin chemotherapy and during chemotherapy to measure its effectiveness in preventing weight loss, a common side effect of the cancer treatment. Weight loss can lead to cachexia, a life-threatening wasting syndrome associated with chronic diseases including cancer. Cachexia is estimated to affect millions of people worldwide.

"This is a pivotal step in finding a solution for those who suffer from weight loss when they undergo treatment for cancer," said Russell Potterfield, Chief Executive Officer and Executive Chair of Endevica. "We are excited to offer hope to patients and their families to address a condition for which there are no effective treatments available. We believe that B07 could be the breakthrough solution and are excited to begin enrolling patients in our trial."

Endevica Bio this year completed a Phase 1 clinical trial of B07, a peptide, for cancer-related cachexia, with preliminary findings supporting its strong safety and efficacy. A separate study, published in November in the Journal of Clinical Investigation, showed that B07 improved the appetite and preserved lean mass and fat mass in rodent models of cancer chemotherapy. The study showed the strong potential of B07 to alleviate chemotherapy-induced anorexia and weight loss for millions of patients worldwide.

Chemotherapy is the standard of care when treating most advanced malignancies. The side effects have a significant detrimental impact on a patient's quality of life and decrease the ability of patients to complete their full chemotherapy routine. Proactively treating chemotherapy-induced anorexia and weight loss can provide an overall better outcome for patients by improving their ability to tolerate treatments and allowing them greater self-sufficiency.

"Patients who develop cachexia face limited treatment options due to fat and muscle wasting," said Dr. Daniel Marks, Chief Medical and Scientific Officer at Endevica Bio. "In our Phase 2 clinical trial, we hope to demonstrate that by taking a proactive approach before chemotherapy begins, we will prevent weight loss that can lead to cachexia and ultimately improve patients' outcomes during treatment."

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. More information can be found at www.endevicabio.com.

Media Contact:

Dan Childs

Next Solutions Group (NSG)

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SOURCE Endevica Bio