CONSTANT THERAPEUTICS TXA127 FOR COVID-19 TO ENTER NIH-FUNDED CLINICAL TRIAL AT 60 SITES AROUND THE U.S.
As the focus on the COVID-19 pandemic shifts to raising the number of vaccinated people around the world, U.S. researchers, funded by the NIH, are undertaking a large new clinical trial to find effective treatments, in the belief that while controllable, SARS-Cov-2 and its variants will continue to cause endemic disease in many parts of the world.
“While vaccine effectiveness continues to decrease hospitalizations in the U.S., those patients who are hospitalized with COVID-19 are still in need of therapies that improve symptoms and decrease oxygen dependency. This trial will help us understand how TXA127 hastens recovery in patients with COVID-19 and will contribute to our understanding of how restoring balance to the Renin Angiotensin Aldosterone System (RAAS) impacts patient outcomes.” said Sean Collins, MD, MSci, Principal Investigator of the ACTIV-4d trial, Co-Director of the Vanderbilt Coordinating Center and Professor of Emergency Medicine, Vanderbilt University Medical Center (VUMC).
TXA127 targets RAAS which is thrown out of balance by SARS-CoV-2, the virus that causes COVID-19. Binding of the virus to the enzyme ACE2 leads to a reduction in the human peptide Angiotensin-(1-7), which is the active ingredient in TXA127. This results in life-threatening complications, including pulmonary edema, thromboembolic complications and severe cardiac injury.
TXA127 has been shown to reduce fibrosis, stabilize endothelial and epithelial barrier function and reduce inflammation in preclinical models, including models of acute lung injury. "Supplementing Angiotensin-(1-7) with TXA127 has the potential to reverse the disruption caused by Covid-19," said Dr. Rick Franklin, founder and CEO of Constant Therapeutics. "The scientific rationale is compelling. Beyond the acute distress that characterizes COVID-19, other longer-term pathologies associated with the disease include inflammation, large vessel strokes, microthrombosis and effects on the central nervous system, all of which may be the result of reduced levels of Angiotensin-(1-7) in infected patients and may be treatable with TXA127."
The trial will test several compounds, each against a placebo group. The TXA127 segment will involve 300 patients treated with the peptide and will be conducted at some 60 sites nationwide.
The effect of binding of SARS-CoV-2 to ACE2 and the subsequent reduction in levels of Angiotensin-(1-7) is not unique to the SARS-CoV-2 virus. All of the current variants as well as a number of viruses that have caused epidemics in the past employ this same mechanism and should be treatable with TXA127.
About TXA127
TXA127 is a pharmaceutical formulation of the naturally occurring human peptide angiotensin- (1‐7). In addition to its specific effects in lung injury, TXA127 has shown therapeutic activity in animal models of chronic stroke, Duchenne Muscular Dystrophy (DMD), Limb‐Girdle Muscular Dystrophy (LGMD), Congenital Muscular Dystrophy (MDC1A), Marfan Syndrome and Epidermolysis Bullosa.
About Constant Therapeutics LLC
Constant Therapeutics LLC is a private biopharmaceutical company developing peptide and small molecule drugs that are agonists of the alternative renin angiotensin system, the protective arm of the renin angiotensin system (RAS). This protective pathway involves the enzyme ACE2, its principal product, the peptide angiotensin-(1-7), and the peptide’s targets, the Mas and MrgD receptors. Constant’s lead drug candidate is TXA127. For more information on Constant Therapeutics, please visit our website at www.constanttherapeutics.com.