NanoViricides (NYSE-A:NNVC) earlier this week provided an update on the advancement of its broad-spectrum antiviral candidate NV-387, outlining progress in Mpox clinical development and confirming orphan drug designation filings for multiple indications.
Speaking to Proactive, CEO Dr Anil Diwan said the company has completed the full clinical trial application required to initiate a Phase 2 study of NV-387 in the Democratic Republic of Congo for Mpox. Import permissions have been secured and the next steps involve site evaluation, approvals and training before dosing begins.
Diwan noted that although the WHO’s global Public Health Emergency declaration has been lifted, Mpox continues to spread in parts of Africa. He stated that cases “continue to increase in cases” and disperse despite vaccine deployment, supporting the rationale for continued development.
Importantly, NanoViricides confirmed the Phase 2 study is fully funded. The company raised approximately $5.5 million in November and maintains a quarterly spend of about $1.8 million.
Proactive: Alright welcome back inside our Proactive newsroom, and joining me now is Dr Anil Diwan, CEO of NanoViricides. Dr Diwan, great to see you again, how are you?
Dr Anil Diwan: I'm fine. How are you?
I'm doing very well. I know you've had some news out recently. I thought it'd be a great opportunity to get you on to talk about an orphan drug designation that you have filed an application for. We'll get to that in just a second. But also, you've got some news out about the Democratic Republic of Congo and Mpox. I know you've done a phase one study and you're now fully funded for a phase two study. Why don't we start there and talk to me a bit about what's going on?
NV-387 is an extremely broad spectrum drug. We have been fortunate in being able to discover it and bring it to this stage. It worked against many different diseases. We decided to focus on monkeypox for further development because it was a shorter pathway. At that time there was a worldwide epidemic declaration, a Public Health Emergency of International Concern by the WHO.
We were getting accelerated in the programs by the regulatory agency in Africa. We submitted the required summary documents. Although the WHO emergency declaration has come off globally, the emergency declaration in the African region persists because monkeypox is not going away. Cases continue to increase and disperse despite vaccines being deployed.
We were asked to complete a full-fledged clinical trial application, which has now been done. We also obtained import permission for the drug into the DRC. We have passed all of those steps. The next stage is evaluating and approving clinical sites, training them, and then starting dosing. Documentation is in preparation and we think it will take a few weeks.
In the financials you mentioned this is fully funded. You're ready to go when that documentation comes in?
Yes. We raised about $5.5 million in November. We spend about $1.8 million per quarter. Based on that, we have sufficient money to complete this clinical trial. There are no issues with financing.
You're also filing for orphan drug designation for NV-387. What does that mean?
Previously we were working on RSV, which is an $8 billion market. However, clinical trial costs were very high and biotech financing has been poor over the last four years. We needed a faster pathway. RSV and influenza require long, protracted trials.
We evaluated diseases where NV-387 showed strong animal model results — monkeypox, smallpox, and measles. We focused first on monkeypox because of the emergency.
In the US, we assessed how to move rapidly and potentially attract non-dilutive funding. Discussions led us to the orphan drug strategy for NV-387 as a viable pathway with significant benefits, including potentially quicker regulatory approvals.
Smallpox, Mpox and measles represent meaningful markets globally. Measles cases are rising in the US, with more than 25 states affected. When a measles case occurs, large groups must quarantine. If an approved drug were available, prophylactic doses could potentially reduce spread.
We have now filed orphan drug designation applications for NV-387 for the treatment of measles, Mpox, and smallpox.
What sort of timeline are you looking at to hear back from the FDA?
These designation applications are typically handled in three to four months. We are not waiting and are already progressing next steps.
If designated, there are significant benefits: R&D tax credits, fee reductions or waivers, and seven-year marketing exclusivity. Clinical trials are usually smaller and shorter for orphan indications. If an outbreak is ongoing, they can be completed more quickly.
There is also a possibility of accelerated approval after Phase 2, with confirmatory work continuing afterward. That would allow the drug to be sold earlier, which is a benefit for the company.
Quotes have been lightly edited for clarity and style