NEW YORK, April 16, 2020 (GlobeNewswire) — CERESPIR INCORPORATED, a pharmaceutical company engaged in the discovery and development of disease modifying therapeutics for the treatment of neurodegenerative diseases, announced today it has identified a possible heretofore unknown link between COVID-19 induced brain inflammation and Acute Respiratory Stress Syndrome (ARDS), the most common cause of death among infected patients. The company aims to test its clinical stage compound itanapraced as a possible early intervention treatment for COVID-19 patients showing evidence of brain infection.
A retrospective study of COVID-19 patients in Wuhan, China recently published in JAMA Neurology suggests that as many as 34% of patients with COVID-19 showed neurologic signs and symptoms. These phenomena have also been reported in the United States and other countries, and include headache, nausea, vomiting, loss of taste and smell, delirium, and seizures. Rare cases of encephalitis have been reported, and together the findings suggest that the virus may invade the central nervous system (CNS), as was reported for the previous Coronavirus-induced disease Severe Acute Respiratory Syndrome (SARS). The brain’s innate immune system has been shown to be critical in preventing Coronavirus-induced CNS infection in animals but can also result in a harmful “cytokine storm” when immune cells overreact to fight off infection. The blood-brain barrier is present throughout the approximately 400 miles of vessels in the human brain and its integrity is essential to allow for proper neuronal function, as well as protect the brain from toxins, pathogens, injury, and disease. Neuroinflammation can result in damage to the barrier even without a cytokine storm. Breakdown of the barrier following brain injury has been proposed to explain the high incidence (20% to 30%) of ARDS in patients with moderate to severe traumatic brain injury (TBI). CereSpir believes the same may also be true for COVID-19 patients whose brains are infected with the virus. Its compound, itanapraced, was shown to prevent the accumulation of activated immune cells in the injured brain and attenuated both neurological and acute lung injury in a preclinical model of TBI.
“The mechanism we have identified could potentially explain why some people are more susceptible to neurological and pulmonary complications of the disease than others,” stated Dr. Daniel G. Chain PhD, CereSpir’s Founder. “It may also explain why some patients appear to recover initially before ultimately succumbing to the disease. This outcome could occur because, untreated, the infected brain continues to leak proinflammatory factors into the circulation.
“Our hypothesis that COVID-19 infection in the brain could cause ARDS by damage to the blood-brain barrier opens up a new therapeutic strategy that deserves to be explored systematically in controlled human studies,” stated Dr. Adrian N. Hobden PhD, CereSpir’s CEO and President. He added, “We are fortunate to have a promising clinical stage compound, itanapraced, that is all but ready for testing in COVID-19 patients.”
Itanapraced is an orally available, brain-penetrant small molecule that has been tested in over 200 subjects in several Phase 1 studies and a Phase 2 study in mild cognitive impairment (MCI), with favorable results. In addition to good safety and tolerability, itanapraced produced beneficial dose-related differences in cerebrospinal fluid levels of two important neuroinflammatory mediators, TNF-α and soluble CD40L, as well as in levels of total tau, a recognized marker of neurodegeneration. Patients also exhibited stable cognition throughout the duration of the trial. Itanapraced has also been reported to have numerous beneficial effects in preclinical models of Alzheimer’s disease, Parkinson’s disease, TBI and TBI-induced ARDS. Thus, itanapraced appears to be effective in a broad range of disease indications, pointing to a common mechanism linked by neuroinflammation.
CERESPIR is a privately held, science-driven pharmaceutical company with an innovative approach to treating neurodegenerative disorders. The company is seeking academic and commercial partners to help accelerate the development and commercialization of itanapraced for the treatment of COVID-19 and other indications. For more information visit www.cerespir.com.
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