Sunshine Biopharma Inc. (NASDAQ:SBFM) on Wednesday announced it advanced its lead Coronavirus drug candidate into IND-enabling studies.
The company had previously published laboratory results on its library of compounds in August 2024 and more recently in March 2026.
Background and Compound Research
The company said that the nominated drug candidate for advanced development displayed nanomolar potency against the viral protease and had broad-spectrum activity against other SARS-CoV-2 variants of concern in vitro.
It exhibited desirable ADME profiles and was assessed in a general mammalian toxicology study in rats. The drug candidate had high oral bioavailability in mice, rats, and dogs.
Absorption, distribution, metabolism, and excretion (ADME) are the four key steps of pharmacokinetics that describe how a drug moves through the body.
In Addition, it was preferentially enriched in the lungs of both mice and rats.
Dose-Dependent Viral Suppression in Vivo
In the K18-hACE2 mice infected with human SARS-CoV-2 virus, repeated oral administrations of the drug candidate significantly suppressed pulmonary viral replication in a dose-dependent manner.
“The compound’s profile — potent inhibition across SARS-CoV-2 variants, strong oral bioavailability in multiple species, preferential lung enrichment, and dose-dependent viral suppression in the K18-hACE2 model — places us in a highly competitive position as we move toward IND-enabling studies, ” said Steve Slilaty, CEO of Sunshine Biopharma.
These are not incremental data points; they represent a differentiated antiviral candidate with real potential to shape the next generation of coronavirus therapeutics,” Slilaty further added.
In August, Sunshine Biopharma released an update regarding its proprietary oncology initiative, outlining key next steps for its K1.1 mRNA lipid nanoparticle program.
Preclinical studies confirm successful systemic in vivo delivery of K1.1 mRNA lipid nanoparticles.
The candidate demonstrated good tolerability and restored target tumor suppressor expression in grafted liver tumors in a dose-dependent manner.
SBFM Price Action: Sunshine Biopharma shares were down 0.97% at $1.02 during premarket trading on Wednesday. The stock is trading near its 52-week low of $1.01, according to Benzinga Pro data.
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