Sunshine Biopharma Announces Novel Inhibitor for Sars Coronavirus

Rhea-AI Summary

Sunshine Biopharma (NASDAQ:SBFM) has developed an orally active protease inhibitor showing dose-dependent antiviral activity against SARS-CoV-2 in infected mice. The company's lead compound demonstrated effectiveness at sub-micromolar concentrations against PLpro and exhibited antiviral activity in cells infected with various variants of concern.

The compound showed favorable pharmacokinetics in rodents with preferred drug accumulation in the lungs over plasma. Testing in K18-human-ACE2 transgenic mice revealed significant reduction in virus load in infected animals' lungs without notable toxicities. This research is being conducted in collaboration with the University of Arizona.

The company published initial research results on its PLpro inhibitors library in the Journal of Medicinal Chemistry in August 2024 and is now working on process chemistry for scale-up, with plans to proceed to clinical trials.

Positive

• Development of new oral antiviral compound with demonstrated effectiveness against SARS-CoV-2
• Successful preclinical results showing dose-dependent activity without toxicity
• Research validation through publication in Journal of Medicinal Chemistry
• Advancement towards clinical trials phase

Negative

• Product still in early development stage with no guaranteed success
• Clinical trials and regulatory approval process yet to begin
• Significant time and resources required before potential commercialization

Insights

Medical Research Analyst

The development of an orally active protease inhibitor showing dose-dependent antiviral activity against SARS-CoV-2 represents a significant scientific advancement. The compound's ability to target PLpro, a important enzyme for viral replication and immune system suppression, is particularly noteworthy. The research demonstrates promising results with sub-micromolar activity and effectiveness against various variants of concern. Key strengths include favorable pharmacokinetics, preferential lung accumulation and validated efficacy in transgenic mouse models. The publication in the Journal of Medicinal Chemistry adds scientific credibility. However, the early stage of development and pending clinical trials suggest a long path to commercialization. The market potential could be substantial given the continuous emergence of new variants and the need for treatments in immunocompromised patients.

Financial Analyst

For a micro-cap company with a market cap of just $6.66 million, this breakthrough could be transformative. The global COVID-19 therapeutics market remains substantial, though competitive with established players. The company's focus on an alternative therapeutic target (PLpro) differentiates it from existing treatments. However, investors should note the significant capital requirements for clinical trials and commercialization ahead. The stock could see increased attention due to these positive preclinical results, but substantial dilution risks exist given the company's current market cap and the costly development path ahead. The upcoming scale-up process and potential clinical trials will be critical milestones for valuation.

FORT LAUDERDALE, FL / ACCESSWIRE / December 9, 2024 / 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 an orally active protease inhibitor with dose-dependent antiviral activity in mice infected with SARS Coronavirus (SARS-CoV-2).

There are still unmet medical needs for agents to combat SARS-CoV-2 infections. SARS-CoV-2 is the etiologic agent of COVID-19 and one of three types of Coronavirus that cause Severe Acute Respiratory Syndrome (SARS). SARS-CoV-2 undergoes mutation at a rapid rate, which leads to the continuous emergence of variants of concern (VOC) posing a significant threat to public health. In addition, certain populations, such as immunocompromised patients who are susceptible to severe and prolonged infections, may not respond well to current therapies or vaccines. For high-risk patients, 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. 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).

Sunshine Biopharma's current lead compound was recently found to be active at sub-micromolar concentrations against PLpro and exhibited antiviral activity in SRAS-CoV-2 infected cells as well as in cells infected with several different VOC. In addition, the Company's lead compound had favorable pharmacokinetics properties in rodent species and exhibited preferred drug accumulation in the lungs over plasma. The compound was found to be orally active in a K18-human-ACE2 transgenic mouse model and to significantly reduce virus load in the lungs of infected animals in a dose-dependent manner without gross toxicities. This research is being carried out in collaboration with the University of Arizona.

"We are delighted by the tremendous progress we have made in our SBFM-PL4 project," said Dr. Steve Slilaty, CEO of Sunshine Biopharma. "We are currently working on the process chemistry for scale-up and expect to soon enter the next stage of development, including clinical trials."

About Sunshine Biopharma Inc.

Sunshine Biopharma currently has 65 generic prescription drugs on the market in Canada and 29 additional drugs scheduled to be launched in 2025. Among the new drugs to be launched is NIOPEG®, a biosimilar of NEULASTA®. Like NEULASTA®, NIOPEG® is a long-acting form of recombinant human granulocyte colony-stimulating factor (filgrastim). It is indicated to decrease the incidence of infection in patients with non-myeloid malignancies receiving anti-neoplastic therapy.

In addition, Sunshine Biopharma is conducting a proprietary drug development program which is comprised of (i) K1.1 mRNA, an mRNA-Lipid Nanoparticle targeted for liver cancer, and (ii) SBFM-PL4, a small molecule inhibitor of PLpro protease for treatment of SARS Coronavirus infections. For more information, please visit: www.sunshinebiopharma.com.

All registered trademarks are the property of their respective owners.

Safe Harbor Forward-Looking Statements

This press release contains forward-looking statements which are based on current expectations, forecasts, and assumptions of Sunshine Biopharma Inc. (the "Company") that involve risks as well as uncertainties that could cause actual outcomes and results to differ materially from those anticipated or expected. These statements appear in this release and include all statements that are not statements of historical fact regarding the intent, belief or current expectations of the Company, including statements related to the Company's drug development activities, financial performance, and future growth. These risks and uncertainties are further described in filings and reports by the Company with the U.S. Securities and Exchange Commission (SEC). Actual results and the timing of certain events could differ materially from those projected in or contemplated by the forward-looking statements due to a number of factors detailed from time to time in the Company's filings with the SEC. Reference is hereby made to cautionary statements and risk factors set forth in the Company's most recent SEC filings.

For Additional Information:

Sunshine Biopharma Contact:
Camille Sebaaly, CFO
Direct Line: 514-814-0464
camille.sebaaly@sunshinebiopharma.com

SOURCE: Sunshine Biopharma, Inc.

View the original press release on accesswire.com

FAQ

What is the new SARS-CoV-2 treatment developed by Sunshine Biopharma (SBFM)?

Sunshine Biopharma has developed an orally active protease inhibitor that shows dose-dependent antiviral activity against SARS-CoV-2 in infected mice, targeting the PLpro enzyme essential for viral replication.

What were the results of SBFM's preclinical studies for their SARS-CoV-2 treatment?

The compound showed sub-micromolar effectiveness against PLpro, favorable pharmacokinetics in rodents, preferred lung accumulation, and significantly reduced virus load in infected animals without toxicity.

When did Sunshine Biopharma (SBFM) publish their initial research on PLpro inhibitors?

Sunshine Biopharma published their initial research results on PLpro inhibitors in the Journal of Medicinal Chemistry in August 2024.

What is the next development stage for SBFM's SARS-CoV-2 treatment?

The company is currently working on process chemistry for scale-up and plans to proceed to clinical trials as the next stage of development.