today's the be XXXX and of several are risks Thank If please.You'll three during to and X, course that open We'll update. earnings several it note we'll subject we and and for morning, good up making of could course over much, going uncertainties. the we'll joining to you be go statements to answers. then or questions Angela, very forward-looking today's XX everybody, the and Slide quarter presentation, XX slides you through next thank minutes,
the You the have Virios. about that should with for filed documents complete SEC more information we read
guidance, an that to mention for potential FDA to agreement treatment quarter III fibromyalgia. IMC-X a our of plan to patients first achievements, slide, key and to please.The like our I'd is with the progress absolutely Next relative past Phase thing as securing one is development on
As to parts. Phase clearly only. therapy, new respond U.S. study Phase IIb represent program you we'll the research to the the enriching to the majority patients of most IMC-X likely are fibromyalgia the and target That said, proposed may recall, patients as be the III that program III opportunity four in such, Phase to of territory.The is identified these vast comprised patients
the This primary the the trial. assessed at multifactorial or up this XXX XXX effect endpoint be XXX requirements studies. effect therapy.Patients the for Phase We pain, patients and the component will drug III XXX used treatment.The of and of from the study, this comparing in the XXX total pharmacokinetic trial or XXX study be required will reduction our new again, a precursor XXX completing we've study this food again, and and will to FDA the This happy will IMC-X more Patients will discuss X agreed Phase or FDA gain patients program. the into start adding components using is IMC-X, study FDA treated a both presuming and months off XXX, XX This treated study. will XXX into be IIb, X targeting consistent a of but This reference program. groups, trial. study XXX multifactorial randomized of food will further and placebo Effectively, extension. with year. is patients group the in and These X by in key with pharmacokinetic NDA, the again, a will during randomized our study is as of be XXX reference X independent be second proposal will to patients is of of of Celecoxib required we'll III.The and X:X safety to Phase study is application that long-term same patients opportunity extension. the comparing for to per key of in program XXX, Famciclovir be fibromyalgia program X treated this for total a an be enrolled the be XXX approval. and XXX will the III affecting study consistent patients the These the XXX end will in and Patients the focused roll Phase endpoint for the the to endpoint head-to-head be be will this We'll at weeks with a the this in requirement detail we drug. a the opportunity for the XXX This the study be have XXX to to be in approval success will new groups XXX Very drug with be XXX to XXX, of The on is using commercialize placebo total XX over IMC-X formulation question answer. in to have year.Data for be the for weeks. in rolled is in endpoint the be study. the submitted a at dose primary IIa, Phase endpoint second in with long-term treated into
a Drug a the go various can suggest treatment our for Disease significant X application, develop Long-COVID. Long-COVID. is for X.X% on and valacyclovir it's estimates please.As the the as IMC-X Center very Food COVID have a contains the new associated you diligently prevalence research IMC-X. different called, is worked on little Administration is proposed slide, disability long X, a over celecoxib. upwards IMC-X Next third IND, is of term famciclovir symptoms. team for very between exciting as or with materials drug It XX% or submit celecoxib, non-hospitalized program.Recent patients Slide adults has quarter to than There to investigation This who for and on of whereas Control see somewhere IMC briefing to and and sequelae
fact, study in with that attributed Australia 'XX or COVID associated SARS-COVX is of found to In the Long-COVID. and a actually XXXX disability total virus in XX%
there disability this highlighting to of presently effectively, in patient is cohort due of no all X/X to approved will associated morbidity Long-COVID, with very particular of by So tell was the the this it infection, significant treatments COVID sequelae. treat X/X due only the to acute long-term illness.I FDA you are whereas the
medicine. this submission with identify IND to this FDA's regulatory potential alignment, for first-in-class goal the the is requirements Our for
note filed X potential viruses property at to to associated X has provides project protection particular as you'll least we this of research combination, in what Slide next intellectual #X, weeks.What makes provide method next COVID extensions. which have We long-term use before the slide, this cause with can feedback new to as granted exciting? the opportunity for this first-in-class XXXX the Mechanistic -- program provisional of We'll Force Pathways transition on we have a Task RECOVER potential sequelae. coverage that so secondary activation identified to
know. is of impacts the working the under that to second, of address Just up looking created what all work Institute for done of RECOVER response, the may pathways the the or groups both of diverse widespread they broader the Long-COVID. was initiative This know very and I both mechanistic within a you umbrella think force, for and task have are is Long-COVID.COVID initiative to which COVID one they to National is recovery we and COVID very etiology a acute RECOVER developing determined, immune back activates this or a infection, really Health catalyst significant
a can to that to patients. on matched for and lead age, nature one the disease of their treatment.As latent the to Importantly, in severe infections long-COVID of because you viral demonstrated were those patients viruses. very immune reactivation the their and with go as response can sequelae. grant exhaustion to is lead dysregulation they of of requested the as everybody COVID level important? viruses next slide Center. you'll celecoxib which controlled that an by our Long-COVID here turn, but immune were actually Latent in X, assess of group non-COVID patients you, the Recall to significant generated can of the as who can each and #X, fatigue the on a were of gender, see, the potential that long-term for potential latent not Long-COVID exploratory of herpes a Bateman of reactivation viruses combination virus open-label different patients the -- and host in development a valacyclovir this COVID.Importantly, sequelae.If trial, of were rows Center weeks of Page those because to identify system, treatment investigational grant by delivered and actually the table the immune activation Epstein-Barr statistically this of were lead particular, an very COVID important a valacyclovir to sequelae. debilitated as that of see very a cause inflammation, is is whole we and to long-term Dr. In treatment Horne target compared and of Bateman knows, after for result exhibiting unrestricted further can the IMC-X of Horne Bateman is of treated target improvements COVID herpes a please, data that patients. These generated val/celecoxib XX patients IMC-X. significant specifically slide, purposes, the and both assess compared we significant Epstein-Barr and response, data the herpes Why exhibit reactivation tell are we're valacyclovir those
also orthostatic showed primary impression a and generated endpoint, is statistically a in those the orthostatic relevant.The assessments these including depression. which the of assessment clinically global anxiety, p validated relevant of match intolerance and every depression particular the controls.In were then X.XXX, of P level. in sequelae, highly score, fatigue reductions with This with you statistically for measures improvement significant we pain, combination statistically instrument fact, if overall patient's at is is those the value those the exception significant every val/celecoxib PROMIS several statistically only change, through NIH and other take was and one of look particular see and of in a status, at assessed. patients this intolerance, both versus the fatigue NIH one for Specifically, disease measures clinically And, anxiety health study, values statistically including treated X.XXX significant, highly virtually of an
on These had and particularly and is these that treatment morbidity, most with the for larger So, particularly ferret pain. just statistically up we and bed significant sample because both very out this size a be this a work, sample control and are a particularly larger first, particular in muscle moving was for impact X-year not compelling may significance popped the years. a direction mortality, out encouraged to size.These think of a able getting this treated to the data We're common in with adverse was celecoxib these events and then period Long-COVID by the going events well because and group were this very not valacyclovir/celecoxib of in of suffering trial, combination both the This because were valacyclovir adverse something serious care the the is average headaches in generally combination. w no in important were group in and match routine not for patients group data There patients particular period. tolerated.
really well going in trial.We're So, this forward, this is quite thesis open-label this significant a responding test because again. we're exploratory very that's to excited illness moving
through measures Dr. doses the final placebo.These a in size, weeks And to this drug size Phase planned requested XX val/celecoxib effect both cetera, will new planning IIb on over required guide grant for like idea our middle overall the about in grant. forward you XX fatigue, the to those assessing expand for trial financial excited next unrestricted requirements alignment second assessed cohorts, with quarter before on for the FDA turn topic and in will the things we treatment trial, and will partnerships. research patients and orthostatic results consistent X investigator-initiated this potential course on of we and investigator-initiated update Dr. the for key assuming stage second XXXX.And results development patients X be believe funding in be Bateman opportunity our like particular of this combination very intolerance, each I'd from the what's of We're this grant the the application. we sample trial, investigational look et the the is highlights to Bateman help sometime the IMC of and with program team her In are area. fact, the targeting to assumptions, of investigation
please. slide, Next
As are well exploring both partnership Updates will the as on Long-COVID. FDA. you IMC-X Fibromyalgia actively IMC-X follow Slide communicated, Long-COVID on can we've from #X, feedback for we as for as see for likely
we it value. complementary Virios make addition, In assessing interventions we're clear to also shareholder wanted that build to therapeutic
at and/or space probably looking complements create research opportunities we're unique in you know, Specifically, pain opportunities but leadership value under expert as and IMC-X.As can development IMC-X and anti-infective that the partnership the for and various just thorough of discussions opportunity. and for Phase commercial analysis program, a IIb review of the sake timing III the and a fibromyalgia deep reiterating, include data, of very proposed Phase to details
things time. take these of All
to Walsh, that President progress our Angela material quarter highlights. relative We timely will highlights, partnership once our summarize Finance, me over very Vice again, X Senior financial turn let manner.With to a background Angela? it proposed operational report to of on any in
