Clarus Therapeutics and McGill University Announce Licensing Agreement to Develop and Commercialize Technology to Treat Coenzyme-Q10 Deficiencies
Agreement to accelerate development of potential treatments for rare, endocrine, metabolic, and neurological conditions associated with primary and secondary ubiquinone deficiencies which belong to the wider class of mitochondrial diseases | An estimated 1 in 5,000 adults worldwide has a mitochondrial disease | Clarus to pay McGill $350,000 upfront and up to $10.5 million in potential development and regulatory milestones
NORTHBROOK, Ill. and MONTREAL—Sept. 16, 2021—McGill University, ranked by Maclean’s Magazine as Canada’s top ranked medical doctoral university for 16 consecutive years, today announced a licensing agreement with Clarus Therapeutics Holdings, Inc. (“Clarus”) (Nasdaq:CRXT), a pharmaceutical company dedicated to providing solutions to unmet medical needs by advancing androgen and metabolic therapies for men and women, whereby Clarus will develop and commercialize McGill’s proprietary technology designed to treat conditions associated with CoQ10 deficiencies in humans.
CoQ10 is synthesized in the inner membrane of mitochondria, a cellular organelle whose primary function is to produce the body’s chemical energy. Deficiencies of CoQ10 can lead to severe multiple organ dysfunctions that involve the brain, nerves, kidneys, heart, GI tract and muscle. Oral CoQ10 is largely ineffective because it does not result in intracellular uptake of CoQ10. McGill has identified a method to substantially increase such uptake, thereby forming the basis for a new, and potentially profound, method of addressing deficiencies of CoQ10.
“This collaboration with world-renowned McGill University expands our focus beyond androgen-based medicines to a metabolic therapy for CoQ10 deficiencies that have very limited treatment options,” said Dr. Robert Dudley, Clarus’s Founder, President and Chief Executive Officer. “Knowing the role McGill’s discovery may have to address this important, unmet medical need is a terrific opportunity, and we are excited to get started.”
McGill’s discovery, a combination of CoQ10 plus caspofungin (an FDA-approved antifungal drug for adults and children), was made by Dr. Siegfried Hekimi and his colleague, Dr. Ying Wang. Dr. Hekimi is a Professor of Biology and holds the Robert Archibald & Catherine Louise Campbell Chair in Developmental Biology. He is an expert in aging research and a Fellow of the Royal Society of Canada, which awarded him the Flavelle Medal for his outstanding contribution to biological science.
“Deficiencies of CoQ10 are a major medical challenge, and I am delighted that a discovery from my laboratory has been licensed by Clarus,” said Dr. Hekimi. “We look forward to working with the excellent team at Clarus to bring forward a treatment that could be potentially game changing for individuals afflicted with a severe lack of CoQ10 as well as individuals with other mitochondrial disease.”
Terms of the Agreement
Under the terms of the licensing agreement, Clarus will pay McGill a one-time upfront payment of $350,000 and up to $10.5 million in potential development and regulatory milestone payments. Additionally, McGill would be eligible for up to $30 million in potential commercial milestone payments. The success-based milestones denote important steps associated with building value for these programs.
About Mitochondrial Diseases
Mitochondrial diseases are chronic, genetic diseases that occur when the mitochondria, structures in our body cells that produce energy from oxygen and food, fail to function properly. Mitochondrial diseases can affect almost any area of the body and can occur at any age, making them often misdiagnosed. It is estimated that approximately one in 5,000 adults worldwide has a mitochondrial disease.
About Clarus Therapeutics Holdings, Inc.
Clarus Therapeutics Holdings, Inc. is a pharmaceutical company with expertise in developing androgen and metabolic therapies for men and women – including potential therapies for orphan indications. Clarus Therapeutics’ first commercial product is JATENZO®. For more information, visit www.clarustherapeutics.com and www.jatenzo.com.