NanoViricides designs trial protocol for phase II MPox Clade Ia with a novel drug NV-387 for treating MPox disease

Overview

NanoViricides, Inc, a publicly traded company and a clinical stage, leading global pioneer in the development of broad-spectrum antivirals based on host-mimetic nanomedicine technology that viruses cannot escape, announced that the design of the adaptive clinical trial protocol for the treatment of MPox virus clade Ia and Ib infections and disease is nearly complete.

Specifications of the trial

The adaptive clinical trial is designed to provide information on three important aspects in a single, compact clinical trial: 

• Safe and effective dosing regimen in patients; 
• Safety and tolerability of the drug in patients, 
• Antiviral effectiveness of the drug in patients.

Anil R. Diwan on the trial process

The overall clinical trial will enroll approximately 80 patients. ""This is an important milestone towards filing of the clinical trial application and starting the clinical trial,"" said Anil R. Diwan, PhD, president and executive chairman of the company, adding, ""Our CRO and the principal investigator have created a marvelous design that is both frugal and efficient while providing all of the information necessary for understanding the safety and effectiveness of NV-387 for treating MPox disease.""

Present drugs for MPox treatment
Currently there is no drug approved for the treatment of MPox disease that is actually effective for treating the disease.

The NV-387

• NV-387, if it shows effectiveness, will be the very first drug that has shown effectiveness in human clinical trial of an orthopoxvirus.
• If NV-387 is found to be effective in this phase II clinical trial, the company intends to continue further development of NV-387 for treatment of orthopoxvirus infections under a US FDA IND towards studies as needed for regulatory approval of NV-387 for the treatment of MPox as well as smallpox indications. 
• The company intends to obtain regulatory approval in the African region as well, which is likely to arrive before a US approval, and also seek approvals in the European Union and other countries and regions.

MPox & Smallpox

• MPox is an Orphan disease in the USA and treatment of MPox by NV-387 is eligible for orphan drug designation by the US FDA with attendant benefits.
• Smallpox is a bioterrorism agent of concern in the USA as well as across the world and is an important revenue opportunity for the company. Tecovirimat sales to the US Government alone have netted SIGA, the drug holder, over $600 million through December 31, 2024, according to SIGA's annual report to the SEC.

The trial procedure

The adaptive, randomized, standard of care controlled clinical trial will proceed in two parts:

• In phase IIa part, an oral dose of the drug NV-387 given twice daily initially for six days will be compared with the standard of care (SOC) at the hospital for treatment of MPox disease. 
• Patients will be sequestered in the hospital and will be evaluated daily for clinical drug safety and tolerability parameters, and clinical MPox disease evaluation parameters. 
• Additionally, lab evaluations including clinical blood chemistry, CBC, cytokines, urinalysis, ECG, X-rays when necessary, and virological assays will be conducted every 3 days. 
• Based on the results, the Principal Investigator will determine whether additional days of drug dosing can be well tolerated and can improve on effectiveness. If so, the patients will continue to receive same dosing for six more days with same evaluations. The patients will be followed until full resolution of the MPox disease.
• There will be two arms in this phase IIa: The New Treatment Arm of 10 patients with NV-387 dosing plus standard of care and the control standard of care Arm of 10 patients. The dosing regimen for phase IIb will be determined on the basis of phase IIa results.

The phase IIb part of trial

• In the, the clinical trial will be in a 2:1 randomized patients base with approximately 40 subjects in the New Treatment phase IIb part Arm and 20 patients in the standard of care Arm. 
• Evaluations will be similar to those in phase IIa, with more emphasis given to specific points that may have come up in phase IIa regarding safety, tolerability, as well as efficacy.
• The phase IIa will be conducted at a single site in Democratic Republic of Congo (DRC). 
• Phase IIb may be expanded to include additional sites within DRC as well as other countries experiencing severe MPox outbreak in the African Region.

NV-387 Oral Gummies Enter Phase II to Ease MPox Treatment Challenges

• The ""NV-387 Oral Gummies"" drug product formulation will be employed in the Phase II. 
• This is a soft solid formulation that is designed to stick in the oral cavity and dissolve naturally over time, with no solid object (pill or capsule) swallowing necessary. 
• This is important for MPox because MPox causes lesions on mucosal surfaces that make swallowing painful and difficult. 
• MPox is primarily known for the explicit characteristic painful rash on the external skin, but it is a significantly more severe disease than just a skin rash.

US FDA approval

Two drugs, Tecovirimat and Brincidofovir were approved by the US FDA for Smallpox and MPox on the basis of the US FDA ""Animal Rule,"" i.e. based on animal infection and treatment studies only to demonstrate efficacy, and a safety/tolerability human clinical trial.

MPox Drug Failures Highlight Urgent Need as CDC Leads New ""MOSA"" Trial

• Tecovirimat failed in clinical trials for the treatment of MPox with no improvement over the standard of care. Brincidofovir was abandoned in a clinical trial of MPox due to first three patients coming down with drug induced liver injury. 
• Despite this, brincidofovir was recently resurrected under an international coalition led by US CDC and first patient was dosed around January 2025 in the ""MOSA"" clinical trial. 
• Clearly, the threat of MPox Clade 1 causing a potential epidemic in the USA cannot be ignored, and readiness with a drug that works against the same is important to achieve.

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