SheShelton, Connecticut — July 11, 2023 — NanoViricides, Inc. (NYSE American: NNVC) (the "Company"), a leader in the development of highly effective antiviral therapies based on a novel nanomedicines technology, reported today on the strong effectiveness of its broad-spectrum antiviral clinical drug candidate NV-387 in an animal model of lethal lung infection with RSV (Respiratory Syncytial Virus).
NV-387 Can Advance Directly into Phase II Human Clinical Trials for RSV Treatment:
NV-387 is the active ingredient of NV-CoV-2, the Company’s drug for the treatment of COVID and possibly long COVID. It is already in Phase 1a/1b human clinical trials for the evaluation of safety in healthy volunteers and of safety and preliminary efficacy in COVID patients as previously reported.
It is expected that NV-387 can be advanced into Phase II studies against RSV once the current Phase I studies of NV-CoV-2 are completed. This will significantly speed up the development of the RSV drug, save costs, and improve return on investments (ROI).
“We are very pleased with the extremely high effectiveness of NV-387 in combatting RSV”, said Anil R. Diwan, PhD, President and Executive Chairman of the Company, adding, “Importantly, both oral administration and intravenous injection of NV-387 were highly effective. This study further establishes the broad-spectrum antiviral effectiveness of NV-387, and further solidifies our novel nanoviricides platform technology.”
RSV is an Important Acute Lower Respiratory Infection (ALRI; includes Pneumonia) : 1
Each year in the United States, an estimated 58,000–80,000 children younger than 5 years old are hospitalized due to RSV infection. Globally, RSV is a common cause of childhood ALRI and a major cause of hospital admissions in young children. Globally in 2015, 33 million episodes of RSV-ALRI, resulted in about 3·2 million hospital admissions, and 59,600 in-hospital deaths in children younger than 5 years. About 45% of hospital admissions and in-hospital deaths due to RSV-ALRI occur in children younger than 6 months.
There are No Effective Treatments for RSV:
Two vaccines have recently been approved for RSV prophylaxis. Arexvy (GSK), and Abrysvo (Pfizer) were approved in May, 2023 for use in adults over 60 years of age and both reduced severity of RSV infection. There are no vaccines currently approved for infants and children.
However, there are no effective therapeutics for RSV to date. Ribavirin is conditionally approved only for patients with high risk of progressively severe RSV disease, due to significant side effects including hemolytic anemia and kidney failure. Synagis (palivizumab), an antibody, is approved only as a prophylactic in children and infants at high risk of severe RSV infection, but it is not approved for treatment of RSV infection.
Market Size of RSV Therapeutics is Expected to Hit US$ 8.73 Billion by 2031 : 2
GrowthPlus Reports, in June 2023, says the market size for RSV therapeutics was worth $1.8 Billion in 2022, and is expected to grow at a CAGR of 18.9%, reaching $8.73 Billion by 2031.
Lancet 2017; 390: 946–58 1
https://finance.yahoo.com/news/respiratory-syncytial-virus-rsv-therapeutics-093200835.html? 2 guccounter=1&guce_referrer=aHR0cHM6Ly9kdWNrZHVja2dvLmNvbS8&guce_referrer_sig=AQAAAJXyj ZT5Eielym71qZ0IBGYvgi3hzLSE58E-lHgXYBqe05twy3ZebjDbrt
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NV-387 Injection was Found to be Highly Effective Against a Lethal Direct-Lung RSV infection in a Mouse Model:
Animals treated with injection vehicle solution alone survived 7 days. Ribavirin, a toxic drug, was used as a positive control. Animals treated with injections of ribavirin survived 16 days, whereas animals treated with injectable NV-387 survived 15 days, almost matching the efficacy of ribavirin treatment.
NV-387 Administered by Oral Gavage was also Found to be Highly Effective in the Same Lethal Direct-Lung RSV Infection Study:
Animals treated with oral drug vehicle alone survived 7 days. Orally administered Ribavirin, a toxic drug, was used only as a positive control. Animals treated with oral ribavirin survived 16 days, whereas animals treated with oral NV-387 survived 15 days, again almost matching the efficacy of ribavirin treatment.
Unlike ribavirin, NV-387 has been found to be extremely safe in preclinical studies. Therefore, it would be possible to increase the dose level or frequency of NV-387 to increase its effectiveness. Thus this study demonstrates that NV-387 is a highly effective drug candidate for the treatment of RSV infection with significant patient benefits.
NV-387 Demonstrated Very High Oral Bioavailability in This Study:
The dosing of NV-387 orally given was twice as much as that given by I.V. injection to compensate for oral bioavailability. The apparent oral bioavailability of NV-387 based on efficacy parameters appears to be of the order of almost 50% in this study, a very high value.
NV-387 Acts by a Novel Mechanism:
The Company developed NV-387 in response to the COVID pandemic as a broad-spectrum, pan coronavirus antiviral. It was designed to “look like a cell” to the virus, displaying copious amounts of sites to which the virus binds on the surface of the nanoviricide nanomicelle, to trap and destroy the virus particle, rendering it incapable of infecting another cell.
The Company calls this novel antiviral mechanism “Re-Infection Blocker”.
Expanding Indications of NV-387:
NV-387 employs mimics of well known attachment sites on the cells commonly used by viruses called sulfated proteoglycans. Since these attachment receptors are used by over 90% of human pathogenic viruses, the Company anticipated that NV-387 may have effectiveness against many viruses beyond coronaviruses, our initial focus.
RSV is the first non-coronavirus that the Company has evaluated for susceptibility to NV-387.
About NanoViricides
NanoViricides, Inc. (the "Company”) (www.nanoviricides.com) is a clinical 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-CoV-2 for the treatment of COVID caused by SARS-CoV-2 coronavirus. Our other advanced candidate is NV-HHV-1 for the treatment of Shingles. The Company cannot project exact dates for the regulatory activities in progressing its drug candidates because of the Company’s significant dependence on external collaborators and consultants. The Company is currently focused on advancing NV-CoV-2 through Phase I/II human clinical trials.
NV-CoV-2 is the Company’s nanoviricide drug candidate for COVID. NV-CoV-2-R is another drug candidate for COVID that is made up of NV-CoV-2 with Remdesivir, an already approved drug, encapsulated within its polymeric micelles. 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 is also developing a broad pipeline of drugs against a number of viruses, with preclinical safety and effectiveness successes achieved already in many cases. 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 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, enteroviruses, and other viruses that it engages into research for, if the initial research is successful. TheraCour has not denied any licenses requested by the Company to date. 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.
Disclosure Statement
This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors that are, in some cases, beyond the Company's control and that could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company's expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products. In particular, as is customary, the Company must state the risk factor that the path to typical drug development of any pharmaceutical product is extremely lengthy and requires substantial capital. As with any drug development efforts by any company, there can be no assurance at this time that any of the Company’s pharmaceutical candidates would show sufficient effectiveness and safety in human clinical trials to lead to a successful pharmaceutical product, including our coronavirus drug development program.
Contact:
NanoViricides, Inc.
info@nanoviricides.com
Public Relations Contact:
MJ Clyburn
TraDigital IR
clyburn@tradigitalir.com
Source: NanoViricides, Inc.lton, Connecticut — July 11, 2023 — NanoViricides, Inc. (NYSE American: NNVC) (the "Company"),
a leader in the development of highly effective antiviral therapies based on a novel nanomedicines
technology, reported today on the strong effectiveness of its broad-spectrum antiviral clinical drug
candidate NV-387 in an animal model of lethal lung infection with RSV (Respiratory Syncytial Virus).
NV-387 Can Advance Directly into Phase II Human Clinical Trials for RSV Treatment:
NV-387 is the active ingredient of NV-CoV-2, the Company’s drug for the treatment of COVID
and possibly long COVID. It is already in Phase 1a/1b human clinical trials for the evaluation of safety in
healthy volunteers and of safety and preliminary efficacy in COVID patients as previously reported.
It is expected that NV-387 can be advanced into Phase II studies against RSV once the current
Phase I studies of NV-CoV-2 are completed. This will significantly speed up the development of the RSV
drug, save costs, and improve return on investments (ROI).
“We are very pleased with the extremely high effectiveness of NV-387 in combatting RSV”, said
Anil R. Diwan, PhD, President and Executive Chairman of the Company, adding, “Importantly, both oral
administration and intravenous injection of NV-387 were highly effective. This study further establishes
the broad-spectrum antiviral effectiveness of NV-387, and further solidifies our novel nanoviricides
platform technology.”
RSV is an Important Acute Lower Respiratory Infection (ALRI; includes Pneumonia)1:
Each year in the United States, an estimated 58,000–80,000 children younger than 5 years old are
hospitalized due to RSV infection. Globally, RSV is a common cause of childhood ALRI and a major
cause of hospital admissions in young children. Globally in 2015, 33 million episodes of RSV-ALRI,
resulted in about 3·2 million hospital admissions, and 59,600 in-hospital deaths in children younger than
5 years. About 45% of hospital admissions and in-hospital deaths due to RSV-ALRI occur in children
younger than 6 months.
There are No Effective Treatments for RSV:
Two vaccines have recently been approved for RSV prophylaxis. Arexvy (GSK), and Abrysvo
(Pfizer) were approved in May, 2023 for use in adults over 60 years of age and both reduced severity of
RSV infection. There are no vaccines currently approved for infants and children.
However, there are no effective therapeutics for RSV to date. Ribavirin is conditionally approved
only for patients with high risk of progressively severe RSV disease, due to significant side effects
including hemolytic anemia and kidney failure. Synagis (palivizumab), an antibody, is approved only as a
prophylactic in children and infants at high risk of severe RSV infection, but it is not approved for
treatment of RSV infection.
Market Size of RSV Therapeutics is Expected to Hit US$ 8.73 Billion by 20312:
GrowthPlus Reports, in June 2023, says the market size for RSV therapeutics was worth $1.8
Billion in 2022, and is expected to grow at a CAGR of 18.9%, reaching $8.73 Billion by 2031.
1 Lancet 2017; 390: 946–58
2 https://finance.yahoo.com/news/respiratory-syncytial-virus-rsv-therapeutics-093200835.html?
guccounter=1&guce_referrer=aHR0cHM6Ly9kdWNrZHVja2dvLmNvbS8&guce_referrer_sig=AQAAAJXyj
ZT5Eielym71qZ0IBGYvgi3hzLSE58E-lHgXYBqe05twy3ZebjDbrt-
UQegh3oVT7jvFPFYFIUfhjVwW0eguJwwbdSkRaOqkUrwAE38mmEqGdq_TJ1mwmBd95cGsHyvreIVtgd
Vm2RhQfzyUiQvFrjQKvale9YMdc5vLUTFc .
Page 1 of 3
NV-387 Injection was Found to be Highly Effective Against a Lethal Direct-Lung RSV infection
in a Mouse Model:
Animals treated with injection vehicle solution alone survived 7 days. Ribavirin, a toxic drug,
was used as a positive control. Animals treated with injections of ribavirin survived 16 days, whereas
animals treated with injectable NV-387 survived 15 days, almost matching the efficacy of ribavirin
treatment.
NV-387 Administered by Oral Gavage was also Found to be Highly Effective in the Same Lethal
Direct-Lung RSV Infection Study:
Animals treated with oral drug vehicle alone survived 7 days. Orally administered Ribavirin, a
toxic drug, was used only as a positive control. Animals treated with oral ribavirin survived 16 days,
whereas animals treated with oral NV-387 survived 15 days, again almost matching the efficacy of
ribavirin treatment.
Unlike ribavirin, NV-387 has been found to be extremely safe in preclinical studies. Therefore, it
would be possible to increase the dose level or frequency of NV-387 to increase its effectiveness. Thus
this study demonstrates that NV-387 is a highly effective drug candidate for the treatment of RSV
infection with significant patient benefits.
NV-387 Demonstrated Very High Oral Bioavailability in This Study:
The dosing of NV-387 orally given was twice as much as that given by I.V. injection to
compensate for oral bioavailability. The apparent oral bioavailability of NV-387 based on efficacy
parameters appears to be of the order of almost 50% in this study, a very high value.
NV-387 Acts by a Novel Mechanism:
The Company developed NV-387 in response to the COVID pandemic as a broad-spectrum, pancoronavirus
antiviral. It was designed to “look like a cell” to the virus, displaying copious amounts of
sites to which the virus binds on the surface of the nanoviricide nanomicelle, to trap and destroy the virus
particle, rendering it incapable of infecting another cell.
The Company calls this novel antiviral mechanism “Re-Infection Blocker”.
Expanding Indications of NV-387:
NV-387 employs mimics of well known attachment sites on the cells commonly used by viruses
called sulfated proteoglycans. Since these attachment receptors are used by over 90% of human
pathogenic viruses, the Company anticipated that NV-387 may have effectiveness against many viruses
beyond coronaviruses, our initial focus.
RSV is the first non-coronavirus that the Company has evaluated for susceptibility to NV-387.
About NanoViricides
NanoViricides, Inc. (the "Company”) (www.nanoviricides.com) is a clinical 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-CoV-2 for the treatment of COVID caused by SARS-CoV-2 coronavirus. Our
other advanced candidate is NV-HHV-1 for the treatment of Shingles. The Company cannot project exact
dates for the regulatory activities in progressing its drug candidates because of the Company’s significant
dependence on external collaborators and consultants. The Company is currently focused on advancing
NV-CoV-2 through Phase I/II human clinical trials.
NV-CoV-2 is the Company’s nanoviricide drug candidate for COVID. NV-CoV-2-R is another
drug candidate for COVID that is made up of NV-CoV-2 with Remdesivir, an already approved drug,
encapsulated within its polymeric micelles. Remdesivir is developed by Gilead. The Company has
developed both of its own drug candidates NV-CoV-2 and NV-CoV-2-R independently.
Page 2 of 3
The Company is also developing a broad pipeline of drugs against a number of viruses, with
preclinical safety and effectiveness successes achieved already in many cases. 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 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,
enteroviruses, and other viruses that it engages into research for, if the initial research is successful.
TheraCour has not denied any licenses requested by the Company to date. 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.
Disclosure Statement
This press release contains forward-looking statements that reflect the Company's current
expectation regarding future events. Actual events could differ materially and substantially from those
projected herein and depend on a number of factors. Certain statements in this release, and other written
or oral statements made by NanoViricides, Inc. are "forward-looking statements" within the meaning of
Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You
should not place undue reliance on forward-looking statements since they involve known and unknown
risks, uncertainties and other factors that are, in some cases, beyond the Company's control and that
could, and likely will, materially affect actual results, levels of activity, performance or achievements. The
Company assumes no obligation to publicly update or revise these forward-looking statements for any
reason, or to update the reasons actual results could differ materially from those anticipated in these
forward-looking statements, even if new information becomes available in the future. Important factors
that could cause actual results to differ materially from the company's expectations include, but are not
limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents
filed by the company from time to time with the United States Securities and Exchange Commission and
other regulatory authorities. Although it is not possible to predict or identify all such factors, they may
include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe
and effective; successful development of our product candidates; our ability to seek and obtain regulatory
approvals, including with respect to the indications we are seeking; the successful commercialization of
our product candidates; and market acceptance of our products. In particular, as is customary, the
Company must state the risk factor that the path to typical drug development of any pharmaceutical
product is extremely lengthy and requires substantial capital. As with any drug development efforts by
any company, there can be no assurance at this time that any of the Company’s pharmaceutical candidates
would show sufficient effectiveness and safety in human clinical trials to lead to a successful
pharmaceutical product, including our coronavirus drug development program.
Contact:
NanoViricides, Inc.
info@nanoviricides.com
Public Relations Contact:
MJ Clyburn
TraDigital IR
clyburn@tradigitalir.com
Source: NanoViricides, Inc.
Page 3 of 3
