NanoViricides Announces Completion of Production of Lead Candidate for Upcoming GLP Tox Package Studies

NanoViricides has completed manufacture of the drug for the upcoming GLP Safety/Toxicology study of its lead candidate in several kilogram quantities.

The Company has successfully completed production of kilogram-scale quantities of the drug substance, NV-HHV-101. Additionally, the Company has also successfully completed its formulation into the skin cream drug product at several kilograms scale, as is anticipated for the upcoming GLP Safety/Toxicology study.

The Company has achieved an extremely important milestone with this accomplishment. The manufacture of the drug substance and its formulation into drug product were both accomplished under cGMP conditions, at the Company’s facility in Shelton, CT.

The Company believes it has de-risked the cGMP manufacture of not just NV-HHV-101, but that it has also de-risked the entire nanoviricide® platform regarding cGMP manufacturing capability.

The Company further provides an update that it is awaiting comments from the US FDA on its pre-IND application for NV-HHV-101. Those comments, when received, will inform further studies towards IND filing. Once the GLP Tox Package studies are complete, and associated analyses are complete, the Company expects to receive reports from relevant external parties. These reports and a plan of the clinical studies will then be developed into an IND application for NV-HHV-101.

The Company is developing NV-HHV-101 as a broad-spectrum drug against a number of herpes viruses. The Company has chosen shingles rash as the first indication for this drug candidate. It is being developed as a dermal topical cream. It is designed to reduce the local viral load, thereby minimizing rash progression and further nerve damage.

There is a significant unmet medical need for the topical treatment of shingles rash. An effective therapy has been estimated to have a market size into several billions of dollars, if it reduces PHN incidence. An effective therapy against shingles rash reduction alone is estimated to have a market size of several hundred million dollars to low billion dollars. These market size estimates have taken into account the potential impact of the new Shingrix® GSK vaccine and the impact of the existing Zostavax® vaccine.

NanoViricides has previously shown that the NV-HHV-101 drug candidate as well as several related candidates in the pre-clinical optimization phase were highly effective against the shingles virus, VZV (Varicella-Zoster-Virus), in a human skin organ culture ex vivo model of the disease. Further, the non-GLP Safety/Toxicology studies of NV-HHV-101 have shown an excellent safety profile, with no adverse events even at the highest dosages tested in the safety/tox studies.

The Company is also developing drugs against HSV-1 "cold sores" and HSV-2 "genital ulcers", both based on this same drug candidate, although final clinical candidates are in pre-clinical optimization stage for both of these indications at present.

Existing drugs given systemically may not reach required concentrations at the site of shingles outbreak, limiting effectiveness. In addition, VZV does not have an effective TK enzyme that is required for producing active drug from the acyclovir class of pro-drugs, requiring frequent administration of large doses. While shingles presents with a debilitating "pins-and-needles" pain associated with the characteristic rash that is self-limiting within 2-3 weeks in most patients, in a substantial percentage of patients, it presents as a severe, debilitating disease that leads to complications including hospitalization(s) and in some cases may result in extended treatments including subsequent surgeries, as highlighted in NBC-News recently in the article Chickenpox is a lifelong herpes virus that comes with a serious side effect.

Limiting initial viral load is expected to minimize the occurrence of such complications, and is also expected to reduce the incidence of post-herpetic-neuralgia (PHN), which is defined as persistent pain six months or longer after the initial rash has subsided. Shingles occurs when the immune system weakens due to age, stress or other factors such as other immune-compromising diseases (such as HIV or other viral infections) or conditions (such as organ transplant or anti-immune therapeutics against auto-immune diseases). The epidemiological incidence rate of shingles suggests that almost every person will have shingles at least once in lifetime if he/she reaches an age of 85. The available Zostavax® and other live attenuated virus vaccines often lead to "rebound shingles", a less severe form of the disease. The new Shingrix® GSK vaccine does not contain live virus, but is reported to have debilitating side reactions in as many as 20-25% of persons that receive it. Such side reactions may be expected to limit the vaccination rate since shingles is not a life-threatening disease. Besides, Shingrix is not yet widely available, due to limited production capacity. Thus there continues to be a significant unmet medical need for new, effective, therapeutics against shingles.

The present indication for NV-HHV-101 is for the treatment of shingles rash caused by reactivation of the shingles virus, VZV (varicella-Zoster-Virus). VZV causes chickenpox in children as a result of primary infection, and then becomes latent. Reactivation occurs in adulthood when immune surveillance weakens, due to age, stress, or other immune-compromising factors, including other diseases.

NV-HHV-101 is a broad-spectrum nanomedicine designed to attack herpesviruses that use the HVEM (herpesvirus entry mediator) receptor on human cells. This drug candidate is composed of a flexible polymeric micelle "backbone" to which a number of small chemical ligands are chemically attached. The ligands in this case are designed to mimic the binding site of the herpesviruses on HVEM, based on molecular modeling. NV-HHV-101 is expected to bind to VZV via a number of binding sites (i.e. the ligands), thereby encapsulating the virus particle and destroying its ability to infect human cells. This "Bind, Encapsulate, Destroy" nanoviricide® strategy is distinctly different from the mechanism of action of existing antiviral drugs against VZV.

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