Merck and Ridgeback Biotherapeutics Provide Update on New Clinical and Non-Clinical Studies of LAGEVRIO™ (molnupiravir)

  • A preliminary analysis of the University of Oxford’s open label, prospective real-world evidence study, PANORAMIC, conducted in the UK in highly-vaccinated adults mostly <65 years of age, showed no evidence of a difference between LAGEVRIO added to usual care compared to usual care alone for the reduction of hospitalizations and deaths through Day 28 (primary endpoint was not met); the incidence of hospitalizations and death through Day 28 was very low overall (0.8% in both groups).
  • The main secondary endpoint (time to first self-reported recovery) in the PANORAMIC study was 6 days shorter with the LAGEVRIO group compared to the usual care group; in addition, the use of LAGEVRIO also was associated with earlier recovery across a wide range of other symptom measures, as compared to the usual care group.
  • An analysis of real-world data from a separate observational, retrospective study conducted by investigators in Israel (known as the Clalit study) showed that in a cohort of non-hospitalized, high-risk patients, LAGEVRIO reduced hospitalizations and mortality due to COVID-19 in patients 65 years and above; no evidence of benefit was found in younger adults ages 40 to 64 years.
  • Results from a separate, non-clinical 6-month carcinogenicity study in mice demonstrated that LAGEVRIO was not carcinogenic.

Merck( NYSE MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics moment issued the ensuing advertisement regarding data from two real- world substantiation studies assessing LAGEVRIO ™( molnupiravir), an investigational oral antiviral COVID- 19 drug. The first study, PANORAMIC, was conducted by the University of Oxford in the UK in largely- vaccinated grown-ups substantially less than age 65 during the period when the circulating SARS- CoV- 2 variant was generally Omicron. The alternate study, Clalit, was conducted by investigators in Israel in substantially aged grown-ups with underpinning habitual health conditions that make them vulnerable to severe COVID- 19 complaint, also when Omicron was the most dominant strain. The PANORAMICpre-print was published moment and the Clalitpre-print was published last week. also, Merck is reporting results from a recent carcinogenicity study in transgenic mice, which demonstrated that LAGEVRIO wasn’t carcinogenic at any cure tested.

primary results from the PANORAMIC study

The PANORAMIC study, a UK- grounded clinical trial patronized by the University of Oxford, included,783 actors who were randomized to open marker treatment with LAGEVRIO plus usual care( n = ,821) or usual care alone( n = ,962); mean age of actors was

times. Primary outgrowth data were available in,000( 97) actors. Nearly all(> 98) actors were vaccinated, with roughly 95 entering three or further boluses of a SARS- CoV- 2 vaccine. In the primary analysis, the primary endpoint of reduction of hospitalizations and deaths within 28 days of randomization, compared to usual care, wasn’t met;0.8 of cases in both the LAGEVRIO group( n = ,516) and the usual care group( n = ,484) were rehabilitated or failed in the first 28 days.

On secondary objects, LAGEVRIO was associated with enhancement on a range of measures compared to usual care. The observed standard time to first tone- reported recovery( the main secondary endpoint) was 6 days shorter in the LAGEVRIO group; the median time to first recovery was 9 days on LAGEVRIO( range 5- 23 days)vs. 15 days on usual care( range 7 to not reached). Following adaptation for age and birth comorbidity, there was a substantial estimated enhancement of 4 days in time- to-first recovery in the LAGEVRIO groupvs. usual care group(10.4 daysvs.14.5 days; treatment benefit rate1.36( 95 Bayesian believable interval( BCI)1.3-1.4). The finding on time- to-first recovery was harmonious for LAGEVRIO across crucial groups. Secondary objects weren’t acclimated for multifariousness.
About Ridgeback Biotherapeutics

Headquartered in Miami, Florida, Ridgeback Biotherapeutics LP is a biotechnology company concentrated on arising contagious conditions. Ridgeback requests EbangaTM for the treatment of Ebola and has a late- stage development channel which includes molnupiravir for the treatment of COVID- 19. The platoon at Ridgeback is devoted to developing life- saving and life- changing results for cases and conditions that need titleholders as well as furnishing global access to these drugs. In line with Ridgeback’s charge for indifferent global access, all Ridgeback services and treatment for Ebola cases in Africa are delivered free of charge.
About Merck

At Merck, known as MSD outside of the United States and Canada, we’re unified around our purpose We use the power of leading- edge wisdom to save and ameliorate lives around the world. For further than 130 times, we’ve brought stopgap to humanity through the development of important drugs and vaccines. We aspire to be the premier exploration- ferocious biopharmaceutical company in the world – and moment, we’re at the van of exploration to deliver innovative health results that advance the forestallment and treatment of conditions in people and creatures. We foster a different and inclusive global pool and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities.

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