Endevica Bio has received FDA authorization to initiate a Phase 2 clinical trial evaluating TCMCB07 (B07) for the prevention of weight loss in cancer patients undergoing chemotherapy. The study will enroll 100 patients diagnosed with stage 4 metastatic colorectal cancer, administering the peptide drug both before and during chemotherapy treatment.
Weight loss is a common and serious side effect of chemotherapy that can progress to cachexia, a life-threatening wasting syndrome estimated to affect millions of people worldwide with chronic diseases including cancer. Currently, there are no effective treatments available for this condition.
"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."
Promising Clinical Development Path
Endevica Bio completed a Phase 1 clinical trial of B07 earlier this year, with preliminary findings supporting its safety and efficacy profile for cancer-related cachexia. Additionally, a study published in November in the Journal of Clinical Investigation demonstrated that B07 improved appetite and preserved both lean mass and fat mass in rodent models undergoing cancer chemotherapy.
The preclinical research highlighted B07's potential to alleviate chemotherapy-induced anorexia and weight loss, which could benefit millions of patients worldwide who struggle with these debilitating side effects.
Addressing a Critical Unmet Need
Chemotherapy remains the standard of care for most advanced malignancies, but its side effects significantly impact patients' quality of life and often prevent completion of full treatment regimens. By proactively addressing chemotherapy-induced anorexia and weight loss, B07 could potentially improve overall outcomes by enhancing patients' ability to tolerate treatments and maintain self-sufficiency.
"Patients who develop cachexia face limited treatment options due to fat and muscle wasting," explained 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."
Innovative Mechanism of Action
TCMCB07 is a melanocortin-3/4 antagonist peptide designed to cross the blood-brain barrier and act on previously inaccessible target receptors. This novel approach aims to modulate the body's behavioral and metabolic response to chronic illness.
The drug candidate has shown significant lean muscle mass retention in preclinical animal trials, effectively reversing cachectic conditions. These results have been consistent across cachexia arising from various chronic diseases, suggesting potential broader applications beyond cancer-related weight loss.
Endevica Bio's technology platform, protected by a family of patents and pending applications, focuses on the modification of peptides to modulate activity of important drug targets behind the blood-brain barrier. This approach represents a potential breakthrough in addressing the challenging condition of cachexia, for which current therapeutic options remain severely limited.
