Endevica Bio Initiates Phase 2 Trial for Cancer Weight Loss Drug

27 December 2024
Endevica Bio, a privately owned pharmaceutical company based in Northbrook, Illinois, has initiated a Phase 2 clinical trial for their innovative peptide drug, TCMCB07 (B07). This trial aims to assess the drug's ability to prevent weight loss in patients with stage 4 metastatic colorectal cancer who are undergoing chemotherapy. The trial has received authorization from the U.S. Food and Drug Administration and involves administering B07 to 100 patients both before and during their chemotherapy treatment. The primary goal is to evaluate B07's effectiveness in mitigating weight loss, a prevalent side effect of chemotherapy that can lead to cachexia. Cachexia is a severe wasting syndrome associated with chronic conditions like cancer and affects millions globally.

Russell Potterfield, the Chief Executive Officer and Executive Chair of Endevica Bio, highlighted the significance of this trial as a major step forward in addressing weight loss during cancer treatment. He expressed optimism that B07 could become a groundbreaking solution for this condition, which currently lacks effective treatment options. Following the successful completion of a Phase 1 trial earlier this year, where B07 demonstrated promising safety and efficacy, there is renewed hope. Additionally, a study published in the Journal of Clinical Investigation in November indicated that B07 can enhance appetite and maintain lean and fat mass in rodent models undergoing cancer chemotherapy. These findings suggest that B07 has strong potential to counteract chemotherapy-induced weight loss and anorexia for a vast number of patients.

Chemotherapy is a standard treatment for advanced cancers, but its side effects significantly affect patients' quality of life and their ability to complete their treatment regimens. Addressing chemotherapy-induced anorexia and weight loss is crucial, as it can improve patients' overall outcomes by enhancing their treatment tolerance and independence. Dr. Daniel Marks, Chief Medical and Scientific Officer at Endevica Bio, emphasized the trial's objective to demonstrate that a proactive approach, starting before chemotherapy, can prevent weight loss leading to cachexia. This, in turn, could enhance patients' treatment success and quality of life.

TCMCB07, the drug under investigation, is a melanocortin-3/4 antagonist peptide designed to treat cachexia. It represents a first-in-class peptide drug capable of crossing the blood-brain barrier and interacting with previously unreachable target receptors. By doing so, it aims to modulate the body's behavioral and metabolic responses to chronic illnesses. Pre-clinical trials in animals have shown that TCMCB07 can significantly retain lean muscle mass, effectively reversing the cachectic condition across various types of chronic diseases.

Endevica Bio is dedicated to developing first-in-class peptide drug candidates. The company's proprietary technology platform, safeguarded by a series of patents and pending applications, enables the modification of peptides to influence crucial drug targets behind the blood-brain barrier. This innovative approach holds promise for addressing unmet medical needs in the treatment of chronic diseases.

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