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Molnupiravir? Not So Fast. What About Tollovir? — Here's Why You Should Know What That Means

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The following post was written and/or published as a collaboration between Benzinga’s in-house sponsored content team and a financial partner of Benzinga.

Photo by Martin Sanchez on Unsplash

Merck (NYSE: MRK) announced last Friday impressive results from its COVID-19 antiviral, molnupiravir. As vaccines are requiring a third booster shot and anti-vaccine individuals remain at risk for COVID-19 hospitalization, death, and severe symptoms, the scientific community and Wall Street’s attention has turned to COVID-19 therapeutics as the best way to handle breakthrough infections and potential future surges. Antivirals are the top contenders when it comes to therapeutics.

Merck’s press release revealed that molnupiravir was able to reduce hospitalization or death by about 50% in unvaccinated patients who were not yet sick enough to be in the hospital. In addition, zero patients taking molnupiravir died in the study.

The results were robust enough that the data and safety monitoring board (DSMB) stopped the trial early at its interim point, which will now allow Merck to pursue an Emergency Use Authorization (EUA). However, Merck investors could be making a mistake if they were to assume drug superiority or that no competitor can beat them to the punch line. Another COVID-19 antiviral outshines molnupiravir on many fronts, an antiviral called Tollovir. Tollovir is being tested in clinical trials by Todos Medical (OTCMKTS: TOMDF).

Will Todos Beat Merck’s Molnupiravir?

There are 2 reasons why Tollovir is likely the better antiviral. The first reason is that Tollovir seems to have superior drug efficacy — it appears to work better. Todos released data last week from its study in already hospitalized patients, a much more difficult-to-treat patient population than Merck’s Phase 3 trial, showing that Tollovir reduced hospitalization days, death, and inflammatory biomarkers compared to untreated patients. No exclusions were made for pregnancy, underlying conditions, or vaccination status.

screenshot_2021-10-12_at_3.19.05_pm.png
screenshot_2021-10-12_at_3.19.05_pm.png

Source: Todos September 30th Press Release

Tollovir showed a complete reduction in death from 23.8% to 0%, compared to molnupiravir’s complete reduction of 2.1% to 0%. The main difference here is that Tollovir was given to hospitalized patients at higher risk of death, and molnupiravir was given to people who were not hospitalized. Merck also included patients who were predisposed to progress to hospitalization, which could have skewed results.

Chemical

Chemical

All Natural

Antiviral Comparison Table

Remdesivir (GILD)

Molnupiravir (MRK)

Tollovir (TOMDF)

Patient Population

Hospitalized

Non Hospitalized

Hospitalized

Highly Efficacious in Preventing Death

No

Yes

Yes

Reduces Inflammation

No

No

Yes

Adverse Effects

or

Mutagenic Effects

Yes

Yes

No

Possibly Promotes COVID-19 Variants

Yes

Yes

No

Approved (EUA or full)

Yes

Not Yet

Not Yet

Currently available as a nutraceutical supplement

No

No

Yes

In April 2021 Merck experienced a trial stoppage of hospitalized patients, acknowledging that an antiviral was too late to treat people in the inflammatory stage of the disease. The limitations to treat patients in the inflammatory stage of the disease is a big differentiator between the 2 drugs.

The thing about Tollovir that makes it special is that it is an anti-cytokine product, so it helps reduce inflammation, which can be seen by the reduction in C-reactive protein (CRP) in Todos’ data. Tollovir has a dual mechanism of action that gives it a broader therapeutic effect, especially for hospitalized patients.

The other reason Tollovir appeals to more people is its safety profile and mechanism of action (MOA). The scientific community has renamed the 3CL protease the main protease (Mpro) in the past year. Tollovir targets the same Mpro, 3CL protease, as Pfizer’s (NYSE: PFE) drug PF-07321332 with an all-natural approach versus Pfizer’s chemical targeting. By blocking the 3CL protease, Tollovir prevents viral proteins from forming, which stops replication in its tracks. So, there’s no reason to think it will have safety problems. Concerns over safety are traditionally the biggest barriers to regulatory approval and represent the primary unknown long-term risk of new chemical entities. This bodes well for the eventual approval of Tollovir. It has been administered to 5,000 people, and the ingredients it’s made of (botanical extracts) have been deemed safe for widespread use by multiple regulatory agencies worldwide, including the FDA.

Molnupiravir doesn’t block proteases; it works by promoting mutations in SARS-CoV-2 replication, and it interferes with the same biological target as remdesivir. A similar, but different mechanism is targeted by Atea Pharmaceuticals (NASDAQ: AVIR) drug AT-527 which binds to ribonucleic acid (RNA) polymerase to stop the replication, but doesn’t form mutagenic base pairs like molnupiravir. Because of the mutational risk, Merck’s trial warned enrollees not to have unprotected intercourse while on the drug. Molnupiravir has multiple harmful potential side effects because of its MOA, including promoting cancer or birth defects. While an EUA is likely for molnupiravir for a small subset of patients, widespread use would require more substantial trials and in-depth safety analysis regarding its long-term effects.

The other risk is that increasing mutations in an infected patient can promote the formation of viral variants. With the looming risks of cancer, birth defects, and viral variants, the original developer of molnupiravir, Pharmasset, stopped developing it in 2003. The drug was completely abandoned until Ridgeback Biotherapeutics picked it up very recently and licensed it to Merck. Even Barrons chimed in with a warning from scientists and said “Merck’s Covid pill could pose serious risks.”

Great Possibilities for Todos

As investors start realizing Todos may release interim phase 2 results for Tollovir potentially by the end of October, the stock could also stand to benefit. The competitive advantages of Tollovir may be further verified, and Todos may be in a position for gain.

Gilead (NASDAQ: GILD) and Merck’s market caps both rose by over $10 billion dollars when each released positive data, so the $30 million-dollar TOMDF shares might move this month because every other oral antiviral has failed in the hospitalized setting. Although it's impossible to say for sure or exactly where the stock will move, the demand and excitement surrounding the development of an oral antiviral is pervasive.

The preceding post was written and/or published as a collaboration between Benzinga’s in-house sponsored content team and a financial partner of Benzinga. Although the piece is not and should not be construed as editorial content, the sponsored content team works to ensure that any and all information contained within is true and accurate to the best of their knowledge and research. This content is for informational purposes only and not intended to be investing advice.

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