TAIPEI and SAN DIEGO, Aug. 16, 2021 -- Senhwa Biosciences, Inc. (TPEx: 6492), a new drug development company focused on human efficacy and innovation of first-in-class therapeutics for oncology, rare diseases, and novel coronaviruses, today announced that its novel oral drug, Silmitasertib, has reached the enrollment goals for its Phase 2 investigator initiated trial (IIT). Silmitasertib targets the protein kinase CK2 pathway and is regarded as possessing great clinical potential in treating COVID-19.
The study enrolled a total of 20 patients with moderate COVID-19 at 2 clinical sites within the United States. The open-label, randomized, 2 arm parallel-group controlled, interventional prospective study is evaluating the safety, tolerability and pharmacokinetics of Silmitasertib 1000 mg taken twice daily in patients diagnosed with moderate COVID-19. This trial also seeks to compare time to clinical recovery and clinical benefit across the treatment groups.
“We are excited to have the Phase 2 IIT fully enrolled and once all patients have completed the study we are eager to start evaluating the safety and efficacy of Silmitasertib.” said Tai-Sen Soong, Chief Executive Officer of Senhwa Biosciences.
As of August 4th, 2021 the total number of COVID-19 cases worldwide has surpassed 200 million and the highly contagious Delta variant has accounted for more than 93 percent of all new COVID-19 cases in the United States, according to the U.S. Centers for Disease Control and Prevention. “The Delta variant or any other variant strains are unlikely to affect either the anti-viral or anti-inflammatory efficacy of Silmitasertib since it does not directly target coronavirus proteins, but the host protein kinase CK2 pathway, which the virus uses to replicate. CK2 protein kinase does not mutate and as such, it is an excellent target for the design of a potent antiviral agent," said Dr. John Soong, Chief Medical Officer of Senhwa Biosciences.
Silmitasertib is safe, and easily administered due to its oral formulation. In preclinical studies it has been shown to inhibit viral replication in infected cells, as well as reducing the body’s over active inflammatory response to the SARS-CoV-2 infection. Currently, there is another ongoing Phase 2 IIT of Silmitasertib which is treating patients with severe COVID-19 in the United States. Silmitasertib is also being provided under compassionate use for patients with severe COVID-19 in Taiwan (treatment was initiated in June 2021).