Senhwa Completes Enrollment of a Phase 2 Investigator Initiated Trial of Silmitasertib as Novel Oral Drug for COVID-19


TAIPEI and SAN DIEGO, Aug. 16, 2021 /PRNewswire/ — 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).

About Silmitasertib

Silmitasertib is a first-in-class small molecule drug that targets the CK2 (casein kinase 2) pathway and acts as a CK2-inhibitor. It is safe and well-tolerated in humans. In addition to COVID-19, Silmitasertib is currently under development in several oncology programs in adults and children with recurrent/advanced or metastatic cancer. To date, three Phase I trials and one Phase II trial of Silmitasertib in cancer patients have been completed; currently, there are two ongoing Phase II studies of Silmitasertib in cancer patients. US FDA granted Silmitasertib an Orphan Drug Designation for the treatment of Cholangiocarcinoma in December 2016, a Rare Pediatric Disease Drug Designation for the treatment of Medulloblastoma in July 2020, and an eIND for the treatment of a patient with severe COVID-19 in August 2020.

About Senhwa Bioscience

Senhwa Biosciences, Inc. is a new drug development company focusing on human efficacy and innovation of first-in-class DNA Damage Response therapeutics, addressing unmet medical needs in oncology. Headquartered in Taiwan, with an operational base in San Diego, California, Senhwa is well-positioned to oversee the development of its compounds.

Silmitasertib (CX-4945) and Pidnarulex (CX-5461), both with novel mechanisms of action as anti-cancer drugs for the treatment of multiple indications, are the core products in Senhwa Bioscience’s pipeline. Clinical trials are currently ongoing in Australia, Canada, United States, Korea and Taiwan.

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Source: Senhwa Biosciences, Inc.