Endevica Bio Begins Phase 2 Trial for Drug Targeting Weight Loss in Cancer Patients
Endevica Bio, a private company focused on innovative peptide therapeutics, has announced the commencement of a Phase 2 clinical trial for its experimental peptide drug TCMCB07 (also referred to as B07). This trial aims to address weight loss issues in patients battling stage 4 metastatic colorectal cancer who are receiving chemotherapy. The recent authorization from the U.S. Food and Drug Administration (FDA) marks a crucial step in Endevica's journey to offer potential relief to cancer patients facing severe weight loss due to treatment.
The trial will involve 100 participants diagnosed with colorectal cancer. These patients will be administered B07 before and during their chemotherapy regimens. Weight loss is a common side effect of chemotherapy that can lead to cachexia—an alarming syndrome that causes severe muscle mass and fat loss, resulting in a significantly diminished quality of life and poor treatment outcomes.
Russell Potterfield, CEO of Endevica, stated, "This is a pivotal step in finding a solution for those who suffer from weight loss when they undergo treatment for cancer. 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."
In preparation for this pivotal trial, Endevica has successfully completed a Phase 1 clinical trial earlier this year, validating B07's safety and efficacy. Preliminary results showed promising outcomes, supporting the hypothesis that B07 could effectively mitigate the weight loss associated with cancer treatment.
Moreover, a recent study published in the Journal of Clinical Investigation highlighted that B07 had a significant positive effect on rodent models. It improved appetite and preserved both lean mass and fat mass, showcasing its potential to combat chemotherapy-induced anorexia—a major concern for cancer patients.
Chemotherapy is a common treatment for advanced malignancies, yet the side effects can be debilitating, often leading to reduced treatment adherence. Patients suffering from cachexia face limited treatment options which directly affect their recovery and overall quality of life. Addressing these issues proactively can significantly enhance treatment outcomes.
Dr. Daniel Marks, the Chief Medical and Scientific Officer of Endevica, emphasized the urgency of the situation. He pointed out that initiating treatments like B07 before the onset of chemotherapy could mitigate significant weight loss, thus potentially improving patients' experiences and outcomes. "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," he explained.
TCMBC07 is regarded as a melanocortin-3/4 antagonist peptide candidate specially designed for treating cachexia. The drug's unique ability to cross the blood-brain barrier allows it to affect target receptors that were previously inaccessible, modulating the body’s response to chronic illnesses. Preclinical trials have shown that patients administered this peptide retained significant lean muscle mass during treatment.
Endevica Bio is pioneering the development of first-in-class peptide drug candidates. Supported by a robust technology platform and a comprehensive portfolio of patents and applications, Endevica is dedicated to modifying peptides for optimal therapeutic effect. More information about the company and its innovative work can be accessed on their official website: Endevica Bio.
The trial will involve 100 participants diagnosed with colorectal cancer. These patients will be administered B07 before and during their chemotherapy regimens. Weight loss is a common side effect of chemotherapy that can lead to cachexia—an alarming syndrome that causes severe muscle mass and fat loss, resulting in a significantly diminished quality of life and poor treatment outcomes.
Russell Potterfield, CEO of Endevica, stated, "This is a pivotal step in finding a solution for those who suffer from weight loss when they undergo treatment for cancer. 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."
In preparation for this pivotal trial, Endevica has successfully completed a Phase 1 clinical trial earlier this year, validating B07's safety and efficacy. Preliminary results showed promising outcomes, supporting the hypothesis that B07 could effectively mitigate the weight loss associated with cancer treatment.
Moreover, a recent study published in the Journal of Clinical Investigation highlighted that B07 had a significant positive effect on rodent models. It improved appetite and preserved both lean mass and fat mass, showcasing its potential to combat chemotherapy-induced anorexia—a major concern for cancer patients.
Chemotherapy is a common treatment for advanced malignancies, yet the side effects can be debilitating, often leading to reduced treatment adherence. Patients suffering from cachexia face limited treatment options which directly affect their recovery and overall quality of life. Addressing these issues proactively can significantly enhance treatment outcomes.
Dr. Daniel Marks, the Chief Medical and Scientific Officer of Endevica, emphasized the urgency of the situation. He pointed out that initiating treatments like B07 before the onset of chemotherapy could mitigate significant weight loss, thus potentially improving patients' experiences and outcomes. "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," he explained.
About TCMCB07
TCMBC07 is regarded as a melanocortin-3/4 antagonist peptide candidate specially designed for treating cachexia. The drug's unique ability to cross the blood-brain barrier allows it to affect target receptors that were previously inaccessible, modulating the body’s response to chronic illnesses. Preclinical trials have shown that patients administered this peptide retained significant lean muscle mass during treatment.
About Endevica Bio
Endevica Bio is pioneering the development of first-in-class peptide drug candidates. Supported by a robust technology platform and a comprehensive portfolio of patents and applications, Endevica is dedicated to modifying peptides for optimal therapeutic effect. More information about the company and its innovative work can be accessed on their official website: Endevica Bio.
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