Senhwa Announces IND Submission to India's CDSCO of a Phase II Clinical Study for Silmitasertib as a Potential COVID-19 Treatment

Senhwa Biosciences, Inc., a clinical-stage biopharmaceutical company focused on developing first-in-class therapeutics for the treatment of cancer, rare conditions, and novel coronaviruses, today announced that it has submitted an Investigational New Drug (IND) application to India's Central Drugs Standard Control Organization (CDSCO) to evaluate its investigational drug, Silmitasertib, for the treatment of COVID-19. The trial is a phase II multi-center, randomized-controlled interventional prospective study. It is designed to assess the safety, clinical benefit, and anti-viral activity of Silmitasertib in up to 50 patients hospitalized with COVID-19.

Currently, India's health infrastructure has been hit by a catastrophic second wave, reporting nearly 30 million coronavirus infections, including more than 380,000 people killed by the virus as of June 2021. "It is obvious that despite many countries, including India, making good progress in vaccination, long-term effects and disease sequelae in COVID-19 survivors will become another challenge; so development of new antiviral drugs is still a top priority for the entire world," said Tai-Sen Soong, Chief Executive Officer of Senhwa Biosciences.

Like other RNA viruses, SARS-CoV-2 is constantly evolving through random mutations. Any new mutations can potentially increase or decrease infectiousness, virulence, and the virus's ability to evade adaptive immune responses from past SARS-CoV-2 infection or vaccination. "The Indian trial provides an expansion of Silmitasertib's clinical program to evaluate anti-viral activity and clinical benefits. Variant strains are unlikely to affect either the anti-viral or anti-inflammatory efficacy of Silmitasertib since our drug does not directly target coronavirus proteins, but the host protein kinase CK2 (casein kinase 2) pathway, which is important for virus survival and replication. 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.

From the preclinical studies, Silmitasertib not only showed the potential to fight against SARS-CoV-2, but also demonstrated decent inhibition of HCoV-229E in the anti-viral assay, one of the other seven known coronaviruses to infect humans.

Senhwa's Silmitasertib is an oral medication, which challenges both the virus' ability to replicate quickly and spread to nearby healthy cells, and the body's uncontrolled inflammatory response to SARS-CoV-2 infection. Currently, there are two ongoing Phase II COVID-19 Investigator-Initiated Trials in the US. Silmitasertib is also provided under compassionate use for patients with severe COVID-19 in Taiwan, China Region of China (treatment was initiated in June 2021).

About Silmitasertib

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 an Orphan Drug Designation for treatment of Cholangiocarcinoma in December 2016, a Rare Pediatric Disease Drug Designation for treatment of Medulloblastoma in July 2020, and an eIND for treatment of a patient with severe COVID-19 in August 2020.

About Senhwa Bioscience

Senhwa Biosciences, Inc. is a leading clinical-stage company focusing on developing first-in-class, next-generation DDR therapeutics for patients with unmet medical needs in oncology. Headquartered in Taiwan, China Region of China, 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, China Region of China.