Revidia Therapeutics Inc., a cardiac regenerative medicine company developing first-in-class small molecule drug therapies for heart injury, has announced that it has expanded its leadership team in preparation for an FDA Investigational New Drug (IND) application and clinical trials.
Michael Christensen, Ph.D., will serve as Revidia’s new executive vice president for business development and Michael Stein, M.D., F.A.C.C., will serve as the company’s new vice president for clinical development. Christensen and Stein are highly experienced drug developers who bring over 50 years of combined expertise in clinical trial development and execution, regulatory and medical affairs, and business and marketing operations to the Revidia team. Ed Turnley, J.D., will serve as the new vice president for legal and regulatory affairs.
Kevin Strange, Ph.D., Revidia’s founder, president and CEO, also announced that Revidia has been awarded its second National Heart, Lung, and Blood Institute (NHLBI) Direct to Phase II Small Business Innovation Research (SBIR) grant.
Revidia’s lead drug candidate, MSI-1436, is the only small molecule in development that activates the innate regenerative and repair mechanisms in damaged heart muscle, offering new hope for patients with heart failure and other types of heart disease and injury. Revidia is initially advancing MSI-1436 into clinical trials as a treatment for heart injury in Duchenne muscular dystrophy (DMD) patients.
“We are extremely grateful for the additional support from the NHLBI,” Strange said. “This new, non-dilutive funding will allow us to finalize FDA-required safety and toxicity testing of our lead drug candidate, MSI-1436. We anticipate filing our first IND application within twelve months and launching clinical trials soon after.”
“Revidia’s second peer-reviewed NHLBI award underscores our enthusiasm for the company’s novel science, the potential clinical impact of its lead drug candidate, and its outstanding CEO and lead scientist, Dr. Kevin Strange,” said Christensen, who is also CEO of Prometheus Cardiology and Rare Disease (PCRD), a cardiac regenerative medicine company that recently completed a partnership deal with Revidia.
DMD is a rare and fatal genetic disorder caused by mutations in the dystrophin gene that leads to severe degeneration of heart and skeletal muscle. Most DMD patients die in their late twenties from heart failure. There are no FDA-approved therapies for this fatal condition.
MSI-1436 functions by inhibiting protein tyrosine phosphatase 1B (PTP1B) via a novel mechanism. PTB1B disrupts signaling pathways that control intrinsic regeneration and repair processes in damaged tissues and acts as a “brake” on the heart’s natural repair mechanisms. By releasing this brake, MSI-1436 stimulates the repair and regeneration of damaged heart muscle and improves heart function.
“We have demonstrated in three unrelated animal models and six types of cardiac injury that MSI-1436 stimulates cardiac tissue regeneration and repair and improves heart function,” Strange said. “Importantly, improvement in heart function is long lasting after cessation of MSI-1436 treatment.”
Most companies in the DMD space are focused on treating skeletal muscle, rather than heart muscle, damage. Many are developing genetic therapies designed to partially restore dystrophin function with the goal of reducing symptoms associated with skeletal muscle degeneration.
“While hopeful, these experimental genetic treatments have not yet shown clear and consistent clinical efficacy,” Stein said. “Furthermore, the heart is fraught with many challenges to the effective delivery of gene therapies. Failure to treat heart injury concomitantly with skeletal muscle damage could lead to increased cardiac morbidity and mortality.”
Revidia’s MSI-1436 clinical trials will target DMD patients with impaired heart function. “Our studies will quantify heart function directly, as well as biomarkers of cardiac injury caused by dystrophin mutations,” Stein said. “We are excited to test our lead drug candidate as a treatment to repair and regenerate damaged heart muscle in DMD patients who currently have no effective options.”
About Revidia Therapeutics Inc.
Revidia Therapeutics was founded to address the limitations of stem cell and gene-centric research and development in cardiac regenerative medicine. Our paradigm-shifting approach utilizes novel animal models to identify drug candidates with the ability to reactivate innate regenerative capacity in damaged heart muscle, offering new hope for patients with heart failure and other serious cardiac conditions. Revidia’s first-in-class drug candidate, MSI-1436, is being developed for the treatment of heart failure in patients with Duchenne muscular dystrophy and other life-threatening forms of heart injury. For more information, please visit www.revidiatherapeutics.com.
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Stefanie Matteson