Endevica Reports the U.S. FDA Accepted Its Investigational New Drug (IND) Application for TCMCB07, a Melanocortin‐4 Antagonist Peptide

Clinical Studies of TCMCB07 as a Treatment for Cancer Cachexia to Commence

NORTHBROOK, Ill.--(BUSINESS WIRE)--Endevica Bio, a company developing first-in-class peptide drug candidates with better safety and efficacy properties, announced the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) Application for its lead investigational product, TCMCB07, allowing the company to proceed with initiating clinical studies. TCMCB07 is an investigational melanocortin‐4 antagonist peptide designed to treat cachexia in people that have cancer and other chronic diseases. Endevica Bio plans to initiate Phase 2 clinical studies in pancreatic cancer in 2Q 2023.

“The acceptance of the IND means that Endevica begins its next chapter on our quest to improve the lives of people who are suffering from the effects of cachexia. We have been so encouraged by the pre-clinical data on TCMCB07 that have been generated to date and are looking forward to the next phase of its development,” said Russ Potterfield, CEO and Executive Chairman of Endevica.

“People with cachexia are suffering as their bodies can’t adequately process the nutrients they need to survive. The current standard of care, appetite stimulants and corticosteroids, are not adequate in effectively mitigating this condition,” said Daniel Marks M.D., Ph.D., Chief Medical Officer of Endevica. “TCMCB07 has a lot of promise in its ability to modulate the body’s behavioral and metabolic response to chronic illness, and we are hopeful that it will be proven to be a safe and effective treatment option.”

“We designed TCMCB07 to be a first-in-class peptide drug. We are confident that its ability to cross the blood-brain barrier and act on previously inaccessible target receptors will be profoundly beneficial for patient outcomes. This is just the first product in our pipeline of next-generation peptide therapeutics,” said Kenneth Gruber Ph.D., Chief Scientific Officer and Founder of Endevica.

With the IND in place, Endevica will be finalizing its Phase 2a protocol for a multi-national trial, which is expected to generate robust data about this potentially life-saving compound.

About Endevica Bio

Endevica Bio was formed to create first-in-class peptide drug candidates that form an entirely new class of therapeutics. 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 cancer cachexia, which is the cause of death for up to 40% of cancer patients. More information can be found at www.endevicabio.com.