is endemic it that serious ongoing current will remain we concern Health mutating existing able This prior Organization’s more The immunity to faster Good virus. pace COVID-XX afternoon, quickly and infections. about the from evade of classification COVID-XX an than mutates and COVID-XX also so keeping better concerns of influenza established World the therefore believe pathogen of everyone. is causes it’s issue. boost changing that with an
key strain continued COVID-XX how ability antibodies. identified be in is further that evade mutations to to been circulating the reported have antibodies, with or prone to of the monoclonal it dominant highlighting the monoclonal has use newly was recently EG.X.X generated mutation to virus the linked Interestingly, variant Eris a the Today, U.S. even
acting role the This antivirals treatment for underscores of COVID-XX. oral direct in the important
bemnifosbuvir to action its due new a continue note, this has variants mechanism same maintained barrier high consistently to against and the to to we’re with tested, Importantly be resistance of will confident potency that all variants unique emerge. as
seeing spaces fluctuate of ninth its been the by weeks, to sending couple continue both experiencing are Europe rates in COVID-XX easily. the driven last transmits more wave, and which by infections COVID-XX people and to the air globally. are in conditioned has an wave uptick U.S. heat Japan indoors
four, situation is a both to by a low is Turning to the to response immune Furthermore, patients, and the into heading for X, uptake failure facing a to some any immunity immunocompromised the the infection circulating which and and current exacerbated booster further natural potential there we are between strains mismatch boosters. in available Slide of vaccines. waning mount vaccines,
antivirals with concerns interactions the of use to for approved antivirals Unfortunately, with oral commonly prescribed an their and be infection. currently need immunocompromised those the which to and severe particularly essential, elderly for and with limit risk use. due is medications, still factors unmet underlying therefore going availability is drug-drug there The safety
mutagenicity low of of the study. preclinical believe and We because embryo-fetal compelling bemnifosbuvir profile absence in is its drug-drug the that of and differentiated toxicity risk of interactions
and care deliver Our whom goal for millions effective is a a safe not patients for is option. the to suitable of standard treatment to current the COVID-XX of
recognize for size we the into X, and the current also Slide in the Moving to risk COVID-XX the and success current who patients for criteria eligibility patient high to adapting the are probability rates the are to the bringing SUNRISE-X, taking the to population we environment increase sample study are to most. need the modifications hospitalization account of of it designed death. our promising medicine lower The increasing
world, ourselves as ready they unpredictably XXX capture in goal times. the expanded sites trial be and footprint the our in these approximately and have to of countries. waves targeting different waves across different are we position arrive and COVID geographies now sporadically We to at With global appearing XX is SUNRISE-X, clinical somewhat best,
these to implement we The by protocol reviewed FDA started modifications. amendment been the has have and
the timing amendment should a we guidance XXXX. anticipate mid-XXXX top targeting drug year are this to not line Importantly, program, results application the end continue and new submission and of we change by
shows more the Slide amendment latest detail on a modifications. protocol bit X
and from the years On being have XX broadened down number risk of XX immunocompromised, years modifications prior patient at which population, we patients years or new two criteria. which unchanged. high old with risk at at least old factor is XX least as years XX from being more made the being old now being is to XX at least XX High classified and a a least eligibility down with factors, a a criteria factor, risk risk the with old, are risk
expanded we’ve function. patients include decreased the Additionally, renal to with study
arm, We the have X,XXX monotherapy the supportive hospitalization approximately versus to care in to statistically detect patients or lower X% it’s rates addressed patient reduction powered of sample the of this X% hospitalization hospitalization rates in meaningful assuming a to placebo, size a death and by and death population. increasing clinically in
these anticipation the review will notes at geared and the patients now we initial report care X,XXX DSMB do to XXX review, DSMB monotherapy in approximately efficacy be These safety supportive are analyses line Lastly, towards with the with mid to two futility. and primarily not data analysis top arm interim results, for year. as expect next there
to SUNRISE-X the patients execution believe strong we enroll we Turning emerge. have in to of continues well approximately clinical team, Slide seeing and continue infection X, to our we operational are of as Patient are country. for positioned regulatory we now enrollment and approvals from two-thirds targeted variants waves new and COVID-XX
summary, monotherapy SUNRISE-X on arm. through supportive In approximately high the focusing cause primary risk patients XXin in X,XXX all or death care endpoint patients and is its is the hospitalization Day
hand to program. HCV Arantxa our now call I’ll the Arantxa? review to