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The drug company Merck released promising early data over the weekend on the Covid-19 antiviral it is developing with a private firm called Ridgeback Biotherapeutics, giving the company a shot at an entry into the coronavirus marketafter the failure of its vaccine efforts. The data, which the company presented Saturday at a scientific conference, come from a Phase 2a trial involving 202 adults with symptomatic Covid-19 infections. The company reported that among subjects with infectious virus at the start of their experimental treatment, none of the 47 who received the drug remained positive after five days. Six of the 25 who received the placebo remained positive. Those patients were tested for the purposes of this endpoint not using RT-PCR tests, the so-called gold standard, but rather by isolation of samples in a Vero cell line culture. That is an interesting start, analysts said, though much remains to be seen about the antiviral, which is called molnupiravir. “Good start, not yet definitive,” wrote Mizuho analyst Mara Goldstein in a note out Sunday. “We see these data as incrementally positive for molnupiravir as an oral antiviral therapeutic – supportive of further clinical evaluation – though not yet definitive.”
Merck has not yet published data on the primary efficacy objective of the study, which is reduction in time to a negative RT-PCR test in Covid-19 patients. And while it said that “no safety signals have been identified,” it didn’t offer details on the safety findings. In a note Monday morning, SVB Leerink analyst Daina Graybosch wrote that investors are likely to be frustrated by the missing information. “Although these results… are the most substantive set of clinical data we have seen yet for molnupiravir program, we expect investors will be disappointed by the low level of disclosure, as safety details and results from primary endpoint (viral detection by RT-PCR) were held back for a future undisclosed meeting,” she wrote. Shares of Merck were up 0.8% in premarket trading on Monday. The stock is down 10.6% so far this year, and off 7.4% over the past 12 months. “We continue to make progress in our Phase 2/3 clinical programs evaluating molnupiravir in both outpatient and hospital settings and plan to provide updates when appropriate,” said Roy Barnes, Merck’s head of global clinical development and the chief medical officer of Merck Research Laboratories, in a Saturday statement. Merck is developing molnupiravir in collaboration with a private biotech company called Ridgeback Biotherapeutics.
Despite its position as a leading vaccine developer and manufacturer, Merck dropped its Covid-19 vaccine programs after disappointing early results. The company’s revenue remains heavily reliant on its blockbuster cancer drug, Keytruda. But in a note Monday, Citi Research analyst Andrew Baum wrote that the company’s potential in Covid-19 is “materially underestimated,” and that the data on Saturday raised his expectations for data still to come on trials of the drug. “The accelerated clearance of infectious mRNA in COVID-19 patients treated with oral molnupiravir builds on promising animal data… and increases our confidence for the pending interim phase III analysis of molnupiravir (in out-patient treated COVID-19 patients in particular),” Baum wrote. “Molnupiravir also has potential as a post exposure prophylactic for COVID-19 as well as potential utility for other mRNA viruses such as RSV.” Merck’s 2021 financial forecasts don’t include any potential revenue from Covid-19 therapeutics, Cantor Fitzgerald analyst Louise Chen wrote in a Sunday note.
Merck Press release (March 6, 2021):
