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June 24, 2021

Senhwa seeks India’s CDSCO approval for Phase II Covid-19 drug trial

The trial will assess the safety, clinical benefit and anti-viral activity of Silmitasertib in 50 hospitalised Covid-19 patients.

Senhwa Biosciences has filed an investigational new drug (IND) application seeking India’s Central Drugs Standard Control Organization’s (CDSCO) approval to initiate a Phase II trial of its experimental drug, Silmitasertib, for Covid-19.

An oral small molecule drug, Silmitasertib acts on the casein kinase 2 (CK2) pathway and was found to be safe and well-tolerated.

The multi-centre, randomised, controlled interventional prospective Phase II study will evaluate the safety, clinical benefit, and anti-viral activity of the drug in up to 50 Covid-19 patients who are in hospital.

Senhwa Biosciences chief medical officer Dr John Soong said: “The Indian trial provides an expansion of Silmitasertib’s clinical programme to evaluate antiviral 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 pathway, which is important for virus survival and replication.”

In preclinical trials, Silmitasertib demonstrated the potential to address Covid-19 and hinder HCoV-229E, a coronavirus that infects humans, in the anti-viral assay.

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At present, the drug is being studied in two Phase II Covid-19 investigator-initiated trials in the US, as well as in other trials for treating recurrent/advanced or metastatic cancer.

In another development, the US Food and Drug Administration has approved an IND application of Resolve Therapeutics to commence the Phase II trial of its targeted biologic drug, RSLV-132, in long Covid patients.

RSLV-132 can eliminate pro-inflammatory nucleic acids from circulation, a key trigger of various pro-inflammatory events.

The drug has a catalytically active human Ribonuclease moiety fused to a human Immunoglobulin G1 Fc domain, which can digest ribonucleic acid (RNA) in the blood to reduce inflammation.

Resolve Therapeutics CEO Dr James Posada said that removal of circulating RNA in long Covid patients could lead to an improvement in their fatigue and brain fog.

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