There were a large number of pharma companies of all sizes that began their research on developing both drugs as well as vaccines to counter the SARS-CoV-2 since 2019. Some of these companies have succeeded and gained the limelight, while many others are still continuing their research in order to build more effective forms of medication.
Gilead Sciences (GILD, Financial) seems to have won the race of Covid-19 drug development early on, since it already had an antiviral drug that turned out to be suited to the task. It was thus able to quickly commercialize its remdesivir medication, branded as Veklury, across the globe.
The possibility of enhacing the effectiveness of remdesivir was explored by NanoViricides Inc. (AMEX:NNVC), a development stage biopharma player with its own Covid-19 drug candidate. The company recently carried out a series of tests of its Covid-19 candidate where it acted as an adjuvant to remdesivir, and the results of these tests were extremely promising and propelled the NanoViricides stock. Let us analyze this recent development in more detail, and whether it could make the stock an attractive buy.
A recap of NanoViricides’ Covid-19 research
NanoViricides has been working towards developing pan-coronavirus medication candidates for the treatment of Covid-19 patients. After successfully developing two candidates, the company successfully carried out multiple rounds of tests through cell culture studies as well as through animal models and saw positive results for its NV-CoV-2 candidate, which the management claims could be effective against coronaviruses irrespective of their variant.
The company has developed the NV-CoV-2 as a therapy and independent drug administered along with remdesivir, the most commonly used drug against coronavirus developed by Gilead Sciences. The objective of the research was to eventually push the drug candidates to human clinical trials. However, the biggest challenge for the company was that its candidates were novel drugs and not repurposed drugs like remdesivir, which is why the approval process is significantly longer. This has led to the slow progress and the limited updates from the company over the past few months. However, a recent update with good news has brought the stock back up.
The combination of NV-CoV-2 and encapsulated remdesivir
NanoViricides has been working towards building a combined therapy, named NV-CoV-2-R, where Gilead’s remdesivir is encapsulated inside the NV-CoV-2 nanomicelles to attack the coronavirus lifecycle, both inside and outside the cells, ensuring complete control of the infection. The objective of the drug development was to ensure that NV-CoV-2 can establish a protective envelope around remdesivir to protect it from bodily metabolism, which is bound to improve its effectiveness against Covid-19. NanoViricides recently came out with a press release reporting the significant advantages acquired by remdesivir encapsulation within the NV-CoV-2, and the news was received very positively by the market.
The company performed animal trials using a well-established isotopic internal standard technique of remdesivir evaluation with LCMS (Liquid Chromatography/ Mass Spectrometry) detection. According to the pharmacokinetic study, when remdesivir is given as the encapsulated NV-CoV-2-R form on the first day of dosing on a rat, it doubles the amount of remdesivir in plasma. In addition, remdesivir accumulation was spotted on repeated dosing of NV-CoV-2-R. The study also revealed that after the fifth dose of NV-CoV-2-R compared to the standard remdesivir dosing pattern, the circulating level of intact remdesivir in plasma increased 75% in the NV-Cov-2-R group as compared to the normal remdesivir group. Moreover, the data was normalized to reflect the same amount of remdesivir given to the animals per kilogram of body weight for uniform assessment.
Given the significant results of NV-CoV-2-R encapsulated formulation, it can be expected to improve antiviral efficiency of the remdesivir component in human usage of the NV-CoV-2-R cure. It is worth highlighting that NV-CoV-2-R was less toxic than the standard remdesivir formulation in this pharmacokinetics study. Furthermore, on the seventh day of assessment, when 80mg/kg remdesivir was dosed in the standard formulation, the bodyweight loss was around 9.5% in both male and female animals. In contrast, when 80mg/kg of remdesivir was delivered as NV-CoV-2-R encapsulated formulation on Day 7, the weight loss was approximately 3% in males and 1% in female animals.
These data points exhibit that NV-CoV-2-R could considerably reduce the remdesivir loss to bodily metabolism compared to the standard formulation. This would result in a higher operational concentration of remdesivir in the body with the NV-CoV-2-R sustaining this concentration for a substantially longer period, compared to the standard formulation of remdesivir. Hence, it is expected to be substantially more difficult for the virus to evade than either remdesivir or NV-CoV-2 alone. CEO Dr. Anil R. Diwan anticipates that this stabilizing effect should lead to a highly effective pan-coronavirus medication that could potentially work against most Covid-19 cases.
We can see a big spike in the stock price over the past couple of days after the company's press release. The company has successfully completed the GLP core safety pharmacology studies for the NV-CoV-2 required before the Investigational New Drug (IND) filing with the U.S. Food and Drugs Authority (FDA). The fact that remdesivir is already approved and one of the hottest selling drugs for Covid-19 should help them speed up the approval process.
There is little doubt over the fact that despite all the vaccines being developed, Covid-19 is here to stay, and effective drug-based medication will continue to be required across the globe. Despite all the delays, NanoViricides’ candidate seems to be bringing some genuine value to the table, which is why the stock could be an interesting investment proposition, particularly for biotech investors with a high risk appetite.