By David Willey, Benzinga
The CDC recently issued a warning that Respiratory Syncytial Virus (RSV), a common and highly contagious lung infection that can cause bronchitis and pneumonia, is on the rise in the Southeastern United States – and the very young and the elderly are the most at risk of developing severe incidences of RSV.
Every year, there are over 2 million outpatient (non-hospitalized) cases of RSV in children under 5, and RSV is the leading cause of hospitalizations for young children. There are up to 80,000 hospitalization cases for children under 5, and there are also up to 160,000 cases of patients over 65 getting hospitalized with RSV. Up to 300 children under 5 and 10,000 adults over 65 die of RSV annually. Despite this serious disease, there were no vaccines or good treatment options until recently.
The recently approved vaccines from GSK plc (NYSE: GSK) and Pfizer (NYSE: PFE) also have severe limitations. These vaccines are only for use in patients aged 60 and over. However, these vaccines can involve side effects, including atrial fibrillation, Guillain-Barré syndrome and another potentially related disorder. A recently approved vaccine for pregnant women to protect the newborn infant upon birth has the risk of preterm births.
In July 2023, the FDA also approved Beyfortus, an antibody treatment for children delivered as an injection to help prevent the development of RSV. Beyfortus was developed by Sanofi (NASDAQ: SNY) and AstraZeneca (NASDAQ: AZN). It is expected to be better than a previously approved antibody (palivizumab, trade name Synagis, developed by MedImmune, now marketed by SOBI – Swedish Orphan Biovitrum) for the same indication. Like the vaccines, however, there are side effects associated with these protective antibody treatments, which can include anaphylaxis, a severe allergic reaction.
Yet, there are no treatments for RSV infection except for severe hospitalized cases when children at risk of dying are given the toxic drug ribavirin at very high doses as a last resort.
The market for therapeutics for RSV was worth $1.8 billion in 2022 and will reach $8.73 billion by 2031 at a compound annual growth rate (CAGR) of 18.9% during the forecast period, according to a recent report from Growth Plus Therapeutics. Note that there were no real treatments, only one protective antibody, Synagis, available in 2022.
The therapeutic used for treating RSV is Ribavirin, a highly toxic compound also used as a therapy for hepatitis C. However, Ribavirin carries with it some severe side effects, including the destruction of red blood cells, leading to liver, kidney and spleen toxicities and failures – which limit its use to patients with a high risk of progressively severe RSV. The primary concerning side effect of Ribavirin is anemia, a decrease in red blood cells that can cause a drop in hemoglobin. Ribavirin-induced anemia can manifest within two weeks of starting the therapy and can get worse as the drug dosage increases.
NanoViricides Treatment For RSV
NanoViricides (NYSE American: NNVC), a leading developer of antiviral treatments through its nanomedicines platform, is developing a safe and effective alternative therapeutic for RSV. Its drug candidate, NV-387, has already been shown to not have the toxicity or side effects associated with Ribavirin, according to the company. It reports that in the recent pre-clinical animal study, NV-387 almost matched the efficacy of Ribavirin with no toxicity. This animal study was designed to mimic the lethal lung pneumonia in infants caused by RSV infection.
Importantly, NV-387 is already in phase 1 human clinical trials as the active ingredient in the company’s COVID drug candidate NV-CoV-2. The company has just reported that it was found to be completely safe, with no side effects found to date, in this continuing phase 1 Study. For this reason, the company anticipates soon being able to advance NV-387 to a phase 2 human clinical trial against RSV.
If the results of animal studies are replicated in humans, this nanoviricides drug could become truly a game-changer in the treatment of RSV infections.
NanoViricides, Inc. (the "Company") (www.nanoviricides.com) is a development stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide® class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. Our lead drug candidate is NV-HHV-101 with its first indication as dermal topical cream for the treatment of shingles rash. In addition, we are developing a clinical candidate for the treatment of COVID-19 disease caused by SARS-CoV-2 coronavirus. The Company cannot project an exact date for filing an IND for this drug because of its dependence on a number of external collaborators and consultants.The Company is now working on tasks for completing an IND application. The Company is currently pursuing two separate drug candidates for the treatment of COVID-19 patients. NV-CoV-2 is our nanoviricide drug candidate that does not encapsulate Remdesivir. NV-CoV-2-R is our other drug candidate that is made up of NV-CoV-2 with Remdesivir encapsulated in it. The Company believes that since Remdesivir is already US FDA approved, our drug candidate encapsulating Remdesivir is likely to be an approvable drug, if safety is comparable. Remdesivir is developed by Gilead. The Company has developed both of its own drug candidates NV-CoV-2 and NV-CoV-2-R independently.The Company intends to re-engage into an IND application to the US FDA for NV-HHV-101 drug candidate for the treatment of shingles once its COVID-19 project moves into clinical trials, based on resources availability. The NV-HHV-101 program was slowed down because of the effects of recent COVID-19 restrictions, and re-prioritization for COVID-19 drug development work.The Company is also developing drugs against a number of viral diseases including oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. NanoViricides' platform technology and programs are based on the TheraCour® nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms in perpetuity for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license for poxviruses if the initial research is successful. The Company's technology is based on broad, exclusive, sub-licensable, field licenses to drugs developed in these areas from TheraCour Pharma, Inc. The Company's business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at its foundation in 2005.
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