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Sunshine Biopharma In Collaboration With University Of Arizona Announces Development Of New Series Of Orally Active, Non-Covalent Protease Inhibitors That Show Dose-Dependent Antiviral Activity In Mice Infected With Sars-CoV-2

Author: Benzinga Newsdesk | October 09, 2025 08:02am

Sunshine Biopharma Inc. (NASDAQ:SBFM) (the "Company"), a pharmaceutical company offering and researching life-saving medicines in a variety of therapeutic areas including oncology and antivirals today announced that it has developed a new series of orally active, non-covalent protease inhibitors with dose-dependent antiviral activity in mice infected with SARS Coronavirus (SARS-CoV-2). This work was carried out at the University of Arizona as part of an ongoing collaboration between the Company and the University.

Coronavirus remains a formidable global health threat, not only due to its ability to cause severe illness (particularly in older adults and those with underlying conditions) but also because of its potential to evolve into new variants that may spark future pandemics. The virus's high mutation rate and global reach make it a persistent concern, as even minor genetic shifts can affect transmissibility, resistance to existing treatments, and vaccine efficacy. As such, ongoing investment in antiviral research, rapid-response vaccine platforms, and novel therapeutic approaches is vital to outpace emerging strains and reduce the potentially devastating impact of future outbreaks. Developing smarter, more adaptable treatments is essential for safeguarding global health for tomorrow.

SARS-CoV-2 is the etiologic agent of COVID-19 and one of three types of Coronavirus that cause Severe Acute Respiratory Syndrome (SARS). The other two are SARS-CoV and MERS-CoV. For persons exposed to SARS-CoV-2, blocking early infection at home may prevent rapid disease progression and reduce hospitalization. PLpro is an alternative therapeutic target for developing antiviral compounds against proteolytic processing activity of SARS-CoV-2. PLpro is a virus encoded protease essential for viral replication and is responsible for suppression of the human immune system following infection, leading to a more severe disease outcome.

Previously we had reported that the Company's lead compound had favorable pharmacokinetics properties, including oral availability, in mice, rats and dogs. It was found to be efficacious in a K18-human-ACE2 transgenic mouse model to block SARS-Cov-2 infection in a dose-dependent manner. In August 2024, Sunshine Biopharma published initial research results on its PLpro inhibitors library in the Journal of Medicinal Chemistry (J. Med. Chem. 2024, 67, 13681−13702).

Currently, we report that we have successfully designed and synthesized a second novel chemical series of PLpro inhibitors, which are potent against the PLpro enzyme and exhibited dose-dependent efficacy in cellular models of SARS-CoV-2 infection. These new molecules are orally active in mice and have displayed favorable pharmacokinetics profiles. Work is currently in progress to analyze their dose-dependent efficacy in mice infected with SARS-CoV-2.

"There are still unmet medical needs for agents to combat SARS Coronavirus infections," said Dr. Steve Slilaty, CEO of Sunshine Biopharma. "The development of this new series of highly effective PLpro inhibitors marks a major advancement in antiviral therapeutics. In collaboration with Dr. Gregory Thatcher and Dr. Rui Xiong at the University of Arizona, our dedicated research team has worked relentlessly to identify new compounds that effectively target the viral PLpro enzyme, a key factor in replication and immune system evasion. The promising results demonstrate the potential to significantly curb infection progression and lead to transformative treatments for patients. This achievement is a testament to the unwavering dedication of the University of Arizona team and ours, as we continue to drive innovation in global healthcare."

Posted In: SBFM

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