NanoViricides(US:NNVC)2024-09-27 20:15Clinical Development and Trials - NanoViricides is a clinical stage company with its first drug, NV-387, recently completing Phase Ia/Ib clinical trials for safety and tolerability[15]. - NV-387 demonstrated no drop-outs and no reported adverse events during the clinical trial, indicating strong safety and tolerability[15]. - The company plans to develop NV-387 for pediatric RSV infection, with a Phase II clinical trial planned for adults leading into a Phase II/III trial for children[16]. - NV-387 is currently in Phase Ia/Ib Clinical Trials, with the treatment and observation phase completed by the end of December 2023, and plans for a Phase II trial to evaluate efficacy against RSV infection[76]. - The clinical trial application for NV-387 was submitted during the COVID-19 pandemic, but a proposed second part for COVID-19 treatment was canceled due to lack of eligible patients[94]. - NV-387 is advancing towards Phase II human clinical trials for RSV treatment, expected to save costs and improve ROI[152]. - The company plans to seek regulatory approval for a Phase II human clinical trial for NV-387 as a treatment for RSV infection[105]. - NV-387 is ready for Phase II trials in both oral gummy and syrup forms for RSV and Influenza infections[153][155]. - The company is preparing for IND submissions for injectable solutions of NV-387 for hospitalized patients with RSV and Influenza[153][155]. Drug Efficacy and Safety - NV-387 has shown broad-spectrum antiviral activity against multiple viruses, including RSV, Influenza, and Coronaviruses, suggesting potential for treating various viral infections[25]. - NV-387 has demonstrated a No-Observed-Adverse-Effect-Level (NOAEL) of 1,200 mg/Kg/dose and a Maximum Tolerated Dose (MTD) of 1,500 mg/Kg/dose in safety evaluations, indicating a relatively high safety profile[42]. - NV-387 demonstrated increased survival rates in mouse models with lethal RSV infections, indicating antiviral effectiveness[61]. - In June 2024, NV-387 treatment showed significantly higher survival rates compared to three well-known approved anti-influenza drugs in a lethal Influenza A/H3N2 mouse model study[62]. - NV-387 treatment resulted in a significant reduction in mucus load in the lungs, with a mucus index value of 53 compared to 138 in untreated animals[111]. - NV-387 demonstrated a 75% increase in survival for lethally infected mice when compared to the approved drug Tecovirimat, with a combination treatment (NV-387-m-T) showing a 112% increase in survival[114]. - NV-387 oral treatment led to a 175% increase in survival days compared to the vehicle control in lethal RSV infections[106]. - NV-387 showed an 88% increase in survival days compared to approved influenza drugs, with a survival lifespan of 15 days in treated mice[108]. Drug Development and Manufacturing - NanoViricides operates fully integrated development and manufacturing facilities, enabling rapid drug development from concept to clinical trials within one year[21]. - The company has established a cGMP-capable manufacturing facility in Shelton, Connecticut, capable of producing sufficient drugs for about 1,000 patients in a single batch[85]. - The manufacturing facility is equipped with clean room suites for injectables and other operations, ensuring compliance with FDA regulations for clinical trials[86]. - The company has developed a state-of-the-art nanomedicines characterization lab for in-process quality control and release testing of drug products[86]. - The BSL2 Virology Lab allows for early evaluation of drug candidates against various viruses, enhancing the speed of drug development[87]. - The company has built internal cell culture screening capabilities for developing drug candidates against human coronaviruses and other viral infections, improving the efficiency of candidate evaluation[89]. Financials and Funding - The drug development process is lengthy and costly, and as of the report date, NanoViricides has no approved drugs or revenues[28]. - The company has approximately $4.8 million in cash as of June 30, 2024, and spent about $6.3 million on operating activities during the year, an increase from $5.7 million in the previous year[142]. - The drug development programs have been financed through equity-based financing from private and public offerings, including registered direct offerings and "At the Market" (ATM) offerings[31]. - The company is exploring non-dilutive funding options for various programs in its pipeline to support ongoing development efforts[194]. - The company seeks partnerships for regulatory development and commercialization, which may involve initial license fees and milestone payments[28]. Partnerships and Collaborations - NanoViricides has out-licensed NV-CoV-2 products to Karveer Meditech Pvt. Ltd. for clinical trials in India, with a royalty agreement of 70% of net sales[24]. - The company is actively seeking partnerships for drug commercialization, retaining Aagami, Inc. for collaboration with Indian and Japanese pharma companies[29]. - The company plans to license or co-develop various drug candidates against multiple viral diseases with other pharmaceutical companies[126]. - The company aims to enhance business development efforts by partnering with Aagami, Inc. for licensing and collaboration opportunities[150]. Market Potential and Strategy - The market size for RSV therapeutics is projected to grow from $1.8 billion in 2022 to $8.73 billion by 2031, at a CAGR of 18.9%[125]. - The market for Influenza and Bird Flu therapeutics is estimated at $4.6 billion in 2024, growing to $5.9 billion by 2027, at a rate of 8.5%[125]. - The company has a broad pipeline with over ten drug candidates across nearly forty antiviral drug development programs, anticipating exponential growth upon the approval of its first drug candidate[75]. - The company aims to develop broad-spectrum antivirals mimicking Sialic Acids, which are critical for the binding of various viruses, including Influenza[64]. - The current market size for anti-influenza drugs is approximately $4 billion, with expectations for growth into tens of billions[191]. Intellectual Property and Regulatory Affairs - The company has a total of at least 61 patents issued globally related to its Nanoviricides drugs, with nominal expiry dates ranging from 2026 to 2029[137]. - The company has filed two international PCT patent applications related to coronavirus drug candidates, with the first application filed on June 25, 2021, and the second on June 28, 2022, both potentially expiring in 2043[133][134]. - The FDA's "Animal Rule" allows for the evaluation of drug effectiveness against related animal viruses, facilitating the regulatory approval process for NV-387 as a smallpox therapeutic[122]. - The company aims to bring some regulatory affairs capabilities in-house to expedite regulatory processes in the future[90]. Future Directions and Innovations - The company plans to develop NV-387 for Smallpox treatment, with plans for regulatory trials under the US FDA Animal Rule[156]. - NV-HHV-1, a drug candidate for treating VZV Shingles, has completed pre-clinical IND-enabling studies and demonstrated antiviral activity against HSV-1 and HSV-2[67]. - The company is focused on advancing NV-387 for the treatment of Smallpox/Mpox and exploring its use against influenza in non-clinical studies[76]. - The company is also developing drugs for HSV-1 and HSV-2, with a focus on topical treatments for cold sores and genital ulcers, respectively[177]. - The company aims to maximize return on investments by simplifying the drug development pathway for its anti-herpes drug candidates[176].