Merck’s Molnupiravir Data Accelerates Tollovir Development

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Todos Medical Inc. (OTCMKTS: TOMDF) just announced a major positive update in their development of Tollovir, their COVID-19 antiviral drug. This breaking story uncovered that Merck’s (NYSE: MRK) recently heralded COVID-19 antiviral pill, Molnupiravir, might have to take the back seat to another likely better antiviral made by Todos. Merck’s stock ripped up almost 10% on Friday after releasing interim phase 3 data of molnupiravir in nonhospitalized COVID-19 patients. The stock jumped the equivalent of a whoppiing $16 billion dollars of market capitalization. This is a similar jump to Gilead Sciences’ (GILD) market capitalization jump of about $10 billion dollars when results for remdesivir were first leaked. Clearly, the market values a COVID-19 antiviral very highly. After all, they can save many lives. Merck’s data showed that:

“At the Interim Analysis, 7.3 Percent of Patients Who Received Molnupiravir Were Hospitalized Through Day 29, Compared With 14.1 Percent of Placebo-Treated Patients Who were Hospitalized or Died”

In addition, nobody taking Molnupiravir died within 4 weeks (out of 385 patients) while 8 placebo patients died (out of 377). The media went wild with this news; virtually every media outlet picked up the news with one article even saying that this news means that society can “return to, maybe, normal life.” Merck is planning to seek Emergency Use Authorization (EUA) in the U.S. as soon as it can, and this would make it the first oral antiviral for COVID-19. This valuation jump should be extremely exciting for Todos Medical investors, but there’s much more to the story than just a weighing machine comparison. Merck’s data release and its disclosure that they will move forward for EUA on a smaller set of patients and a lack of long-term safety data means that Todos could close its phase 2 enrollment soon and move straight to phase 3 using the Molnupiravir trial design as a template.

Molnupiravir Progress Is a Major Boon for Tollovir

Todos hinted in its press release that what this Molnupiravir news meant for Todos—that fewer patients will need to be enrolled to gather enough data for EUA.

“Dr. Dorit Arad, Chief Scientific Officer of NLC Pharma commented, ‘Our biggest hurdle in being able to finalize a full development program for Tollovir in the outpatient setting has been trying to decipher what regulators are likely to accept as an approvable endpoint with regards to safety and efficacy. Given the actions of the DSMB in stopping the trials, coupled with the positive comments heard from Dr. Fauci and Dr. Scott Gottlieb with regards to the efficacy demonstrated by Molnupiravir, we are now very comfortable that we have a comparator product against which to build our endpoints for Tollovir. We now intend to engage with regulators in India and in Israel, where we are currently enrolling a double blind placebo controlled Phase 2 clinical study in hospitalized patients with a pending interim data readout, to discuss how we can now finalize a pivotal outpatient trial design(s) and begin to move forward rapidly with enrollment as we prepare a pre-IND meeting with US FDA that will be followed by a well-defined US clinical development program.’”

The press release also revealed that only 6 more patients need to enroll before the DSMB convenes to review the Tollovir data. The company expects enrollment “in the next several weeks.”  Although the company didn’t overtly say the trial would be stopped they certainly expect it.  Investors need to keep in mind 5000 people have had experience with this drug and Todos scientists get how it works and understand its capability.  So what investors could see is a stoppage of the phase 2 Tollovir study and the start of a phase 3 due to the easing regulatory backdrop. The tone of the regulators is easing especially if their rhetoric was so strong with respect to a drug (Molnupiravir) with a checkered past of toxicity. Todos CEO Gerald Commisiong expanded upon this easing regulatory backdrop:

“While it is a tremendous outcome for patients with COVID-19 and the worldwide community at large to have an oral antiviral demonstrate a statistically significant reduction in the most severe outcomes of this devastating disease, it is clear to us from the data we have seen that this decision was likely driven more by the tremendous need in the market for an oral antiviral therapy than by the data itself given the scarcity of safety data available for Molnupiravir and the restrictive entry criteria required for its clinical trial

In other words, it is likely that the DSMB (Data and Safety Monitoring Board) stopping Merck’s trial and the positive comments from Fauci and Gottlieb are mostly driven by an unwavering desire to put an end to COVID-19 deaths that the bar for showing efficacy has been dropped. Merck designed its trial to target patients with nonhospitalized mild or moderate COVID-19 diseases and excluded patients expected to need hospitalization. In other words, these people had symptoms but were likely to be fine anyway. In contrast, Todos Medical’s Tollovir is likely to show more promising data from its phase 2 trial soon, in hospitalized patients. But that doesn’t mean that Tollovir is only for hospitalized patients like remdesivir. The company already sells basically the same product as a supplement online, called Tollovid, which can be taken as a 5-day regimen for immune support if one has come down with COVID, or as a daily supplement, like a prophylactic.

Comparing Molnupiravir to Tollovir

The Merck news is actually a bigger piece of news for microcap Todos Medical than it is for Merck, and investors need to be watching TOMDF shares in the coming weeks as it may prove its antiviral is just as good or better, with a better safety profile.

Efficacy

First, Todos recently released data from an observational study in already hospitalized patients, a much more difficult patient population, showing that Tollovir reduced hospitalization days, death, and inflammatory biomarkers compared to untreated patients. Todos Press Release Now, this is an observational study, not a blinded, placebo controlled study. However, death should not be subject to the placebo effect, and Tollovir managed to reduce death from 23.8% to 0%, a complete, 100% reduction in deaths, just like Molnupiravir. The difference here is that all of the Tollovir patients were already hospitalized, in poor condition and at risk of death, whereas the patients in Merck’s trial were not expected to even have to go to the hospital. Molnupiravir only took a 2.1% death rate down to 0%. One reason Tollovir seems to be a more robust treatment than Molnupiravir is that it is actually not only an antiviral; it is an anti-cytokine product. When patients reach the hospital with COVID-19, they are starting to generate substantial inflammation which is driven by immune signaling molecules called cytokines. Tollovir can reduce the inflammation (as measured by C-reactive protein—CRP), which might give the patient a better chance at regaining lung and other organ function. And this is in conjunction with stopping the virus in its tracks. Molnupiravir doesn’t reduce inflammation. If Todos releases its phase 2 data within the next few weeks and it mirrors what was found in the observational study, Tollovir is shaping up to be a blockbuster drug (over $1.0 billion sales) and potentially the best COVID-19 antiviral in development, or at least superior to Molnupiravir and remdesivir with respect to efficacy.

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Safety

The second key point is that Tollovir has a well established safety profile and the way it works leaves no doubt to its pristine safety profile. Tollovir has already been given to over 5,000 people, and the “ingredients contained within Tollovir have been deemed safe for widespread use by multiple regulatory agencies worldwide, including the US FDA.” This also has to do with where the products come from and how they work. Tollovir is a botanical extract and works by inhibiting the 3CL protease. The 3CL protease is generally accepted as a specific viral protease, with no human protease known to share cleavage specificity. This means that blocking this enzyme will likely not end up blocking important enzymes the body actually needs, which translates to a safe drug target. Molnupiravir, on the other hand, works by increasing copying errors, or mutations, in SARS-CoV-2 (COVID-19) replication, by targeting RdRp, as remdesivir also targets. As such, Merck’s trial design instructed enrollees not to have unprotected intercourse while on the drug. This has a number of potentially alarming side effects including cancer or birth defects due to the drug acting as a mutagen, as well as promoting viral variants. As such, the original developer of the drug, Pharmasset, shelved it almost a decade ago and it was abandoned until Ridgeback picked it up and licensed it to Merck. And these concerns are still very relevant. In fact, some case studies linked remdesivir use to promoting viral variants [1,2]. This might explain Todos’ hint in the press release, that “the Company believes it provides a compelling alternative to newly created or repurposed failed chemical drug candidates that have yet to rigorously demonstrate long-term safety.”

 Magnitude of Effect

The last reason that this is a bigger deal for Todos than Merck is simply because Merck is already a $200 billion dollar company with many products and robust cash flow. One COVID-19 pill will only somewhat move the needle. Comparatively, Todos Medical is an aspiring microcap biotech and a potential blockbuster such as Tollovir could be the engine driving shares to many multiples of the current price. An accelerated drug development matters for Merck but matters much more to a microcap biotech like Todos.

Connecting the Dots

Investors can expect that in the coming weeks Todos Medical may release its phase 2 results for Tollovir, and based on the massive moves from big pharmas, Gilead and Merck, the positive results should have a huge effect on TOMDF shares. If Todos shares jump to a valuation as much as $10 billion dollars, the share price would sit at over $10. But to be much more realistic, if TOMDF shares jumped just 1/20th as much as Gilead or Merck’s shares did, TOMDF would rise to over $0.50, or about 15x the current trading price. And a big move like this could happen in just a few weeks. Todos could then enter a phase 3 trial with Tollovir in COVID-19 hospitalized patients and quickly meet its endpoints to get the drug on the market sooner than anyone might have guessed. The company is currently very overlooked by the market and this is providing investors with a golden opportunity. It could be one of the top performing stocks in the last stretch of 2021.

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