NanoViricides Begins Drug Development Against Severe Pediatric Hepatitis; Expects To Be Successful In Short Period If Existing Candidates In Drug Library Prove Effective

Image sourced from Unsplash

This post contains sponsored advertising content. This content is for informational purposes only and not intended to be investing advice.

NanoViricides, Inc. (NYSE American: NNVC) recently reported that it had begun drug development to combat recent cases of severe pediatric hepatitis. Specifically, the company has initiated a program to screen its library of broad-spectrum antiviral nanoviricides against human Adenovirus 41 Type F (hAd41-F), believed to be strongly associated with the occurrence of severe hepatitis syndrome in some children, causing liver transplants as well as fatalities in large percentages of cases. 

The company’s top priority remains initiating human clinical trials of its SARS-CoV-2 drug candidate NV-CoV-2 to combat COVID-19. The company expects filing of a clinical trial application for COVID-19 to take place fairly soon, although the timelines are outside the company’s control. 

The company has previously successfully developed a drug candidate that was shown to be highly effective in animal studies against adenoviral Epidemic Kerato-Conjunctivitis (EKC), a candidate that is presently in the company’s pipeline for further clinical development. 

The company believes it can successfully develop a drug candidate against hAd41-F in a relatively short period of time, if one or more of its existing pipeline candidates or other nanoviricide candidates in its drug candidate library are found to be effective. To this end, the company is developing an antiviral assay for testing these drug candidates against hAd41-F infection in cell cultures in its own BSL2 Virology facility. 

Adenovirus-41, Type F (hAd41-F) is widely believed to be the cause of the growing number of hepatitis cases in children worldwide that have required liver transplants and have reported fatalities. It is thought that a combination of prior SARS-CoV-2 exposure or infection, along with a current hAd41-F infection, may be responsible for this devastating syndrome, although no definitive cause of this severe hepatitis syndrome has been established. The number of cases worldwide has risen to 450 as of May 15, 2022, as reported by NBC News online. In the USA, the CDC has reported more than 110 cases, with more than 90% requiring hospitalization, of which 14% required liver transplants, and at least 1 fatality, with an additional 5 fatalities under investigation of whether they were caused by the same syndrome.

The company plans to first screen its novel nanoviricides that have been effective against different viruses, including adenoviruses, against hAd41-F once the antiviral assay is established. 

NanoViricides is one of a few biopharma companies that has its own cGMP-compliant manufacturing facility. The company intends to produce its drugs for clinical trials in this facility. The company has the capability to produce sufficient drugs for about 1,000-5,000 patients in a single batch of production, depending upon the drug and the dosage. This production capacity is anticipated to be sufficient for the Phase I and Phase II human clinical trials for our anti-coronavirus drug candidate NV-CoV-2, as well as for the anticipated clinical trials of NV-HHV-101 skin cream for the treatment of shingles. 

The company has previously completed IND-enabling studies for another drug candidate, NV-HHV-101 for the treatment of shingles rash caused by reactivation of the chickenpox virus (aka varicella-zoster virus, VZV). The company plans on further developing the shingles drug candidate into human clinical trials after clinical trials of our COVID-19 drug candidate. The company has additional drugs in its pipeline at various pre-clinical stages that it plans to develop towards regulatory approvals after the COVID-19 and Shingles drug clinical trials. 

While adenoviruses are non-enveloped, the company’s success in developing a highly effective anti-adenovirus nanoviricide to treat EKC is thought to be because of an attack of the nanoviricide onto adenovirus particle uprooting its fibers that are needed for attachment to the human cell, and possibly disruption of the viral capsid integrity by hydrophobic interactions of the nanoviricide’s lipid chains with the capsid penton and hexon protein structures of the virus particle.

Type F adenoviruses and the EKC-causing adenoviruses are substantially different in their cellular receptor homing, and thus tissue tropism, as well as their structure. Thus, Type F adenoviruses bear two types of fibers, short and long, both of which are required for successful cell infection whereas other adenoviruses possess only long fibers.

Most adenoviruses including Type F adenoviruses use Coxsackie-Adenovirus Receptor (CAR) and certain integrins as the cellular receptors. The type F adenoviruses use laminin-binding-integrins, in contrast to the RGD-binding integrins that other types have affinity for. With these differences, although it is possible that the company’s EKC drug candidate shows efficacy against hAd41-F, it is not a certain and therefore experimental screening of the company’s library will be the first step in the company’s Type F Adenovirus program. 

This post contains sponsored advertising content. This content is for informational purposes only and not intended to be investing advice.