NNVC - Multi-Billion Dollar Treatment Market For Lung Infection That Causes Over 200000 Hospitalizations Annually With Elderly Young At Most Risk Has Game-Changing New Entrant
(NewsDirect)
By David Willey, Benzinga
Read the latestreport on NanoViricides here
The CDC recentlyissued a warning that Respiratory Syncytial Virus (RSV), acommon and highly contagious lung infection that can cause bronchitisand pneumonia, is on the rise in the Southeastern United States –and the very young and the elderly are the most atrisk of developing severe incidences of RSV.
Every year, there are over2 million outpatient (non-hospitalized) cases of RSV inchildren under 5, and RSV is the leading cause of hospitalizations foryoung children. There are upto 80,000 hospitalization cases for children under 5 , andthere are also up to 160,000 cases of patients over 65 gettinghospitalized with RSV. Up to 300 children under 5 and 10,000 adultsover 65 die of RSV annually. Despite this serious disease, there wereno vaccines or good treatment options until recently.
The recently approvedvaccines from GSK plc (NYSE: GSK) and Pfizer (NYSE: PFE)also have severe limitations. These vaccines are only for use inpatients aged 60 and over. However, these vaccines can involve side effects , including atrial fibrillation,Guillain-Barré syndrome and another potentially related disorder. Arecently approved vaccine for pregnant women to protect the newborninfant upon birth has the risk of preterm births.
In July 2023, the FDAalso approved Beyfortus ,an antibody treatment for children delivered as an injection to helpprevent the development of RSV. Beyfortus was developed by Sanofi (NASDAQ: SNY) and AstraZeneca (NASDAQ: AZN). Itis expected to be better than a previously approved antibody(palivizumab, trade name Synagis, developed by MedImmune, now marketedby SOBI – Swedish Orphan Biovitrum) for the same indication. Likethe vaccines, however, there are side effects associated with theseprotective antibody treatments, which can include anaphylaxis ,a severe allergic reaction.
Yet,there are no treatments for RSV infection except for severehospitalized cases when children at risk of dying are given the toxicdrug ribavirin at very high doses as a last resort.
The market fortherapeutics for RSV was worth $1.8billion in 2022 and will reach $8.73 billion by 2031 at acompound annual growth rate (CAGR) of 18.9% during the forecastperiod, according to a recent report from Growth Plus Therapeutics.Note that there were no real treatments, only one protective antibody,Synagis, available in 2022.
Thetherapeutic used for treating RSV is Ribavirin, a highly toxiccompound also used as a therapy for hepatitis C. However, Ribavirincarries with it some severe side effects, including the destruction ofred blood cells, leading to liver, kidney and spleen toxicities andfailures – which limit its use to patients with a high risk ofprogressively severe RSV. The primary concerning side effect ofRibavirin is anemia, a decrease in red blood cells that can cause adrop in hemoglobin. Ribavirin-induced anemia can manifest within twoweeks of starting the therapy and can get worse as the drug dosageincreases.
NanoViricides Treatment For RSV
NanoViricides (NYSE American: NNVC), a leading developer of antiviral treatmentsthrough its nanomedicines platform, is developing a safe and effectivealternative therapeutic for RSV. Its drug candidate, NV-387, hasalready been shown to not have the toxicity or side effects associatedwith Ribavirin , according to the company. It reports that inthe recent pre-clinical animal study, NV-387 almost matched theefficacy of Ribavirin with no toxicity. This animal study was designedto mimic the lethal lung pneumonia in infants caused by RSV infection.
Importantly,NV-387 is already in phase 1 human clinical trials as the activeingredient in the company’s COVID drug candidate NV-CoV-2. Thecompany 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 advanceNV-387 to a phase 2 human clinical trial against RSV.
If the results of animalstudies are replicated in humans, this nanoviricides drug could becometruly a game-changer in the treatment of RSV infections.
Learn more aboutNanoViricides’ NV-387 antiviral here.
About NanoViricides
NanoViricides,Inc. (the "Company") (www.nanoviricides.com) is a developmentstage company that is creating special purpose nanomaterials forantiviral therapy. The Company's novel nanoviricide® class ofdrug candidates are designed to specifically attack enveloped virusparticles and to dismantle them. Our lead drug candidate is NV-HHV-101with its first indication as dermal topical cream for the treatment ofshingles rash. In addition, we are developing a clinical candidate forthe treatment of COVID-19 disease caused by SARS-CoV-2 coronavirus.The Company cannot project an exact date for filing an IND for thisdrug because of its dependence on a number of external collaboratorsand consultants.The Company is now working on tasks for completing anIND application. The Company is currently pursuing two separate drugcandidates for the treatment of COVID-19 patients. NV-CoV-2 is ournanoviricide drug candidate that does not encapsulate Remdesivir.NV-CoV-2-R is our other drug candidate that is made up of NV-CoV-2with Remdesivir encapsulated in it. The Company believes that sinceRemdesivir is already US FDA approved, our drug candidateencapsulating Remdesivir is likely to be an approvable drug, if safetyis comparable. Remdesivir is developed by Gilead. The Company hasdeveloped both of its own drug candidates NV-CoV-2 and NV-CoV-2-Rindependently.The Company intends to re-engage into an IND applicationto the US FDA for NV-HHV-101 drug candidate for the treatment ofshingles once its COVID-19 project moves into clinical trials, basedon resources availability. The NV-HHV-101 program was slowed downbecause of the effects of recent COVID-19 restrictions, andre-prioritization for COVID-19 drug development work.The Company isalso developing drugs against a number of viral diseases includingoral and genital Herpes, viral diseases of the eye including EKC andherpes 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 theTheraCour® nanomedicine technology of TheraCour, which TheraCourlicenses from AllExcel. NanoViricides holds a worldwide exclusiveperpetual license to this technology for several drugs with specifictargeting mechanisms in perpetuity for the treatment of the followinghuman viral diseases: Human Immunodeficiency Virus (HIV/AIDS),Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, HerpesSimplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV),Influenza and Asian Bird Flu Virus, Dengue viruses, JapaneseEncephalitis virus, West Nile Virus, Ebola/Marburg viruses, andcertain Coronaviruses. The Company intends to obtain a license forpoxviruses if the initial research is successful. The Company'stechnology is based on broad, exclusive, sub-licensable, fieldlicenses to drugs developed in these areas from TheraCour Pharma, Inc.The Company's business model is based on licensing technology fromTheraCour Pharma Inc. for specific application verticals of specificviruses, as established at its foundation in 2005.
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