14 September 2020 | News
The first eIND Silmitasertib treated severe COVID-19 patient discharged following five days of treatment
Photo Credit: Freepik
Taiwan's Senhwa Biosciences, Inc., a clinical-stage biopharmaceutical company focused on next-generation DNA Damage Response (DDR) therapeutics for the treatment of cancer, has announced that the first patient with severe COVID-19 demonstrated remarkable recovery after treatment with the Company's investigational drug, Silmitasertib.
On August 27, 2020, the Food and Drug Administration (FDA) approved the first emergency IND and authorized use of Silmitasertib in a patient with severe COVID-19 pneumonia requiring supplemental oxygen.
The patient had been treated with multiple therapeutics, including Remdesivir, Dexamethasone, Ceftriaxone, Azithromycin and Enoxaparin within two weeks, but remained hypoxic and required up to 2 liters of supplemental oxygen daily. As none of the available therapeutics worked well for this patient, the investigator decided to try Senhwa's investigational drug, Silmitasertib.
Within 24 hours of the first dose the patient showed significant clinical improvement and the oxygen requirement was weaned to room air. The patient was discharged from the hospital five days after starting Silmitasertib.
Marilyn Glassberg Csete, MD, Chief of Pulmonary, Critical Care, and Sleep Medicine at University of Arizona College of Medicine/Banner – University Medical Center Phoenix and Esa Rayyan, DO, her co-investigator, are now looking for five to ten more patients with severe COVID-19 to treat with Silmitasertib with a plan for a randomized clinical trial in the near future.
Banner – University Medical Center Phoenix is also planning to start a Phase 2, Investigator-Initiated Trial (IIT) of 40 patients. Another Phase 2 IIT will be conducted at the Center for Advanced Research and Education (CARE) in Gainesville, Georgia. The CARE trial will seek to enroll 10 patients once it is approved by the FDA.