Endevica Reports Positive TCMCB07 Data from Single Ascending Dose Portion of Phase 1 Clinical Trial in Cachexia

NORTHBROOK, Ill.–()–Endevica Bio, a company developing first-in-class peptide drug candidates with better safety and efficacy properties, reports initial positive results from the single ascending dose (SAD) arm of the Phase 1 study of its melanocortin‐3/4 antagonist peptide candidate, TCMCB07, for the treatment of cachexia. The study was designed to assess the safety, tolerability, and pharmacokinetics of TCMCB07 in healthy volunteers. Data from the SAD arm showed that TCMCB07 was well-tolerated at a dose above the anticipated therapeutic dose. There were no significant adverse events observed. A multiple ascending dose (MAD) arm is ongoing and is expected to be completed by the end of December 2022.

“This is an exciting milestone for what we believe could be a first-in-class cachexia therapeutic,” said Russ Potterfield, CEO and Executive Chairman of Endevica. “Our mission is to create the next generation of peptide drugs with better safety and efficacy properties. The data that we have seen so far suggest that TCMCB07 will continue to advance in clinical development, furthering this mission.”

Cachexia is a life-threatening aspect to many diseases. The symptoms of this disease include lack of appetite and a loss of muscle disproportionate to the reduction in caloric intake. People suffering from cachexia often have a more difficult time doing day-to-day tasks, fatigue, a reduced quality of life and reduced survival. In advanced cases, cachexia can lead to multi-organ failure due to high metabolic rate-induced apoptosis. According to the American Society of Clinical Oncology, cachexia is highly prevalent across malignancies, impacting approximately half of patients with advanced cancer.

Daniel Marks, M.D., Ph.D., Chief Medical Officer of Endevica said, “It is gratifying to see more than a decade of scientific work move through a successful Phase 1 clinical trial. Cachexia is a common condition that leads to a great deal of human misery. It is exciting to think that we are a step closer to offering patients relief from this devastating condition.”

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 gain (e.g., a reversal of the cachectic condition) during the 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’s technology platform, protected by a family of patents and pending applications, allows for the modification of peptides to modulate activity of G-protein coupled receptors behind the blood-brain barrier. Endevica’s initial drug candidate, TCMCB07, is designed to treat cachexia, which is caused by many diseases like cancer, renal failure and congestive heart failure. More information can be found at www.endevicabio.com.

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