19 Apr Cantex and Michigan Medicine Announce Initiation of a Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Clinical Study to Determine the Safety and Efficacy of Azeliragon in the Treatment of Patients Hospitalized for COVID-19

WESTON, FL and ANN ARBOR, MI April 19, 2023 – Cantex Pharmaceuticals, Inc., a clinical-stage pharmaceutical company focused on developing transformative therapies for cancer and other life-threatening medical conditions, and Michigan Medicine, a part of the University of Michigan and one of the nation’s leading academic medical centers, announced today the initiation of a randomized double-blind, placebo-controlled, multicenter, phase 2/3 clinical study to evaluate the safety and efficacy of azeliragon in decreasing the incidence of acute kidney injury and other life-threatening complications in patients hospitalized for COVID-19.

Cantex’s azeliragon is an orally administered inhibitor of the receptor for advanced glycation end products (known as RAGE). Excessive activation of RAGE has been strongly implicated in life-threatening complications of COVID-19 infection, including lung and kidney failure. A protein produced by the immune system, known as “suPAR”, at high levels predisposes patients to acute kidney injury during critical illnesses, including severe COVID-19. In pre-clinical studies, suPAR’s effects are blocked by azeliragon.

“Our research into suPAR’s role in health and disease has indicated that suPAR plays a role in a broad range of cardiovascular and kidney diseases,” said Salim Hayek, M.D., the Medical Director of University of Michigan Health Frankel Cardiovascular Center Clinics. “Cantex’s azeliragon, by inhibiting the suPAR signaling that produces harmful effects, has potential not only as a treatment of severe COVID-19, but also as a treatment of a broad range of life-altering and life-threatening kidney diseases in which suPAR clearly plays a role.”

“We are pleased to collaborate with Dr. Hayek and his colleagues at Michigan Medicine on this important clinical trial. Dr. Hayek is known for his groundbreaking research identifying suPAR as a causative agent and as an important target for prevention and treatment of a broad range of acute and chronic kidney diseases,” said Stephen G. Marcus, M.D., Chief Executive Officer of Cantex. “With this study initiation, Cantex expands the indications for which azeliragon is being investigated, beyond numerous major cancer indications for which new treatments are needed, including primary and metastatic brain cancer, neoadjuvant therapy of breast cancer, and metastatic pancreatic cancer, to life-threatening inflammatory conditions including severe COVID-19 and acute kidney injury in critically ill patients.”

About Azeliragon
Azeliragon, previously known as TTP488, is an orally active, small molecule, antagonist of the receptor for advanced glycation end products (RAGE) licensed by Cantex from vTv Therapeutics Inc. (NASDAQ:VTVT). vTv Therapeutics discovered azeliragon and carried out phase 3 clinical trials for Alzheimer’s disease. Although these trials did not demonstrate efficacy in Alzheimer’s disease, clinical safety data from these trials, involving over 2000 patients dosed for periods up to 18 months, indicate that azeliragon is very well tolerated. A broad range of evidence indicates that RAGE—ligand interactions play a critical role in cancer and its complications as well as in a range of inflammatory diseases.

About Cantex Pharmaceuticals, Inc.
Cantex Pharmaceuticals, Inc. is a privately held, clinical-stage pharmaceutical company focused on developing transformative therapies for cancer and other life-threatening medical conditions for which new treatments are urgently needed. For more information, please visit www.cantex.com.

About Michigan Medicine

At Michigan Medicine, we advance health to serve Michigan and the world. We pursue excellence every day in our five hospitals, 125 clinics and home care operations that handle more than 2.3 million outpatient visits a year, as well as educate the next generation of physicians, health professionals and scientists in our U-M Medical School.

Michigan Medicine includes the top ranked U-M Medical School and University of Michigan Health, which includes the C.S. Mott Children’s Hospital, Von Voigtlander Women’s Hospital, University Hospital, the Frankel Cardiovascular Center, Kellogg Eye Center, University of Michigan Health West and the Rogel Cancer Center. The U-M Medical School is one of the nation’s biomedical research powerhouses, with total research funding of more than $500 million.

More information is available at www.med.umich.edu.

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Cantex Pharmaceuticals, Inc.:
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