Statistically significant 133% faster time to COVID-19 clinical symptoms recovery versus standard of care (SOC)/best supportive care.
Statistically significant 114% faster time to reach EQ-5D-5L Q6 ≥ 90% versus SOC/best supportive care.
Statistically significant 57% faster time to normalization of COVID-19 related clinical signs versus SOC/best supportive care.
Silmitasertib is a host-directed antiviral and an anti-inflammatory investigational therapy expected to be effective against emerging SARS-CoV-2 variants.
Oral daily dosing was well tolerated with a good safety profile.
TAIPEI and SAN DIEGO, Oct. 20, 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 positive efficacy and safety results from an investigator-initiated, Phase 2 clinical trial of Silmitasertib in approximately 20 patients with moderate COVID-19.
"We are very pleased with the preliminary results of this Phase 2 study, which demonstrated statistically significant and clinically meaningful improvement in relevant endpoints, including time to clinical symptoms recovery and normalization of clinical signs. We believe Silmitasertib in its significant potential in treating COVID-19, both as antiviral and anti-inflammatory agent," said Tai-Sen Soong, Chief Executive Officer of Senhwa Biosciences.
"With the current therapeutic options available are infused and require access to healthcare facility, treatments that can be taken at home are critically needed. We are very encouraged by the results from this study and hope Silmitasertib can make a profound impact in controlling the pandemic," said Dr. Chris Recknor, who led the trial at the Center for Advanced Research and Education (CARE) in Gainesville, Georgia.
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.
Currently, Senhwa Biosciences is the only Taiwanese based company to demonstrate human efficacy against SARS-CoV-2 with its investigational anti-COVID-19 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. Complete safety and efficacy data will be presented after completion of this Phase 2 study.
This open-label, randomized, 2 arm parallel-group controlled, interventional prospective study is evaluating the safety, tolerability and pharmacokinetics of Silmitasertib 1,000 mg BID oral dose in patients diagnosed with moderate COVID-19. The trial also seeks to compare time to clinical recovery and other indicators to demonstrate clinical benefit across the treatment groups.
In the Intent to Treat (ITT) population, Silmitasertib showed a statistically significant and clinically meaningful 133% faster time in recovery of COVID-19-related clinical symptoms (Median: 6 days vs 14 days, p=0.0167, one-sided Type-1 error 0.20), 114% faster in time to reach EQ-5D-5L Q6 ≥ 90% versus SOC/best supportive care (Median: 14 days vs 30 days, p=0.1835, one-sided Type-1 error 0.20) and 57% faster in time to normalization of COVID-19-related clinical signs versus SOC/best supportive care (Median: 7 days vs 11 days, p=0.0557, one-sided Type-1 error 0.20).
Silmitasertib was well tolerated with a good safety profile. No SAEs related to Silmitasertib treatment group were observed.
Silmitasertib and SOC/Best Supportive Care:
The efficacy and safety of Silmitasertib was evaluated in a randomized, open-label, 2 arm parallel-group controlled interventional prospective phase II 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, the standard of care included treatment with dexamethasone and/or other therapies under an Emergency Use Authorization. No patients on the Silmitasertib arm received concomitant COVID-19 therapies.
Regulatory Discussions and Further Study:
We will be providing the safety and efficacy data of this phase II study to the US National Institute of Health (NIH) for further evaluation under the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Program. The ACTIV public-private partnership has evaluated hundreds of available therapeutic agents with potential application for COVID-19, prioritized the most promising candidates, designed and harmonized adaptive master protocols for ACTIV clinical trials, and selected numerous NIH-supported networks to launch these clinical trials to test prioritized therapeutic candidates.
The Company will also seek funding from The Biomedical Advanced Research and Development Authority of the US Department of Health and Human Services (BARDA) and other agencies to fund the estimated amount of commercial drug to supply the needs of the US population, assuming confirmatory positive clinical results and FDA approval.
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 for the treatment of Medulloblastoma in July 2020, and an eIND for the treatment of a patient with severe COVID-19 in August 2020. All clinical trial data belongs to Senhwa Biosciences and IIT studies do not preclude licensing and partnership opportunities.
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.