Early Positive Phase 2 efficacy and safety data are both statistically significant and clinically meaningful.
No SAE related to Silmitasertib was reported.
Silmitasertib is a host-directed antiviral and an anti-inflammatory investigational therapy expected to be effective against emerging SARS-CoV-2 variants.
Silmitasertib is the first Taiwan biotech company's innovative drug to demonstrate efficacy in COVID-19 patients.
TAIPEI and SAN DIEGO, Sept. 27, 2021 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and novel coronaviruses, today announced the acceptance of early positive Phase 2 efficacy and safety data abstract for Silmitasertib in moderate COVID-19 patients at the ISIRV-WHO Virtual Conference-COVID-19, Influenza and RSV: Surveillance-informed prevention and treatment being held on 19-21 October, 2021. The ongoing Phase 2 trial data will be presented at the conference.
The conference will address the evolution, epidemiology and impact of SARS-CoV-2, influenza, RSV and other respiratory viruses, implications for surveillance strategies and progress on vaccines, antivirals, immunomodulators and other countermeasures.
"We are very pleased with the early efficacy and safety results of this Phase 2 study, which demonstrated statistically significant and clinical meaningful reduction in relevant endpoints, including time to recovery and normalization of clinical signs. We believe Silmitasertib in its significant potential in treating COVID-19, both as antiviral and anti-inflammatory agent, helping to prevent effects that lead to severity or death," said Tai-Sen Soong, Chief Executive Officer of Senhwa Biosciences.
The efficacy and safety of Silmitasertib was evaluated in a randomized, open-label, 2 arm parallel-group controlled interventional prospective phase 2 study conducted in two sites in the US. Participants were randomized if they had signs or symptoms of moderate COVID-19 and a positive SARS-CoV-2 RT-PCR or equivalent testing. 20 participants were randomized in a 1:1 ratio to receive 1,000 mg BID oral dose Silmitasertib in addition to SOC/best supportive care or SOC/best supportive care alone for 14 days. During the study, no patients on the Silmitasertib arm received concomitant COVID-19 therapies.
Senhwa Biosciences is the first and only Taiwan based company to demonstrate human efficacy against SARS-CoV-2 with its investigational anti-COVID19 therapy. Silmitasertib targets host cell protein, Casein Kinase 2, and this unique and strategic clinical approach is expected to be effective against the emerging SARS-CoV-2 variants.
Silmitasertib is a first-in-class small molecule drug that targets the CK2 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. US FDA granted Silmitasertib key drug designations, an Orphan Drug Designation for the treatment of Cholangiocarcinoma in December 2016, a Rare Pediatric Disease Drug Designation and a Fast Track Designation for the treatment of Medulloblastoma in July 2020 and August 2021 respectively and an eIND for the treatment of a patient with severe COVID-19 in August 2020. All clinical trial data and rights of Silmitasertib belong to Senhwa Biosciences.
About Senhwa Bioscience
Senhwa Biosciences, Inc. is a leading clinical-stage biotechnology company focusing on developing first-in-class, next-generation DNA Damage Response therapeutics for patients with 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.
Development is currently focused on two lead products Silmitasertib (CX-4945) and Pidnarulex (CX-5461) with novel mechanisms of action and for multiple indications. Clinical trials are currently ongoing in Australia, Canada, United States, Korea and Taiwan.
Visit Senhwa Biosciences website for more details: www.senhwabio.com
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SOURCE Senhwa Biosciences, Inc.