All right. Greg, you, good morning. Thank and
I a company's procedures the Before our the COVID for formulation of to for convey data the required and fibromyalgia long the Phase we dig into have development team initiating thoughts chronic fibromyalgia. FORTRESS me the trial believe We an that us safety previous program with updated study dose IMC-X for plan, program of while results our define success. as protocols PK fibromyalgia to finalizing for clinical the and on enhance program treatment and our to additional let Phase and our forward development trial X results IMC-X and look enabled toxicology from with a along chances the X and a efficacy formulation
COVID, we announced long I label the to like study COVID would long data switching July. in Now the encouraging open design to highlight and
provide and symptoms illness. be This by to illness background think some significant with it associated the morbidity criteria patient COVID I useful itself. long the a the the diagnosed First, would is underpinning includes which on this with
such disease, as suffer and suggest patients more loss also common Long post-acute in from and many PASC. in chronic orthostatic million and asthma, COVID-XX of sequelae females smell hypertension PASC COVID to of or as conditions pre-existing post-exertional severe with brain worldwide dizziness, include obstructive symptoms depression. estimates as fog, is PASC. as sleep intolerance. or malaise, fatigue, people may XX referred disruption, Prevalence It's taste pulmonary
infected lead of ineffective, COVID we can previously was is lasting activate severe to has two herpes an months where based can acute lead cases response. that immune that Organization the COVID Health can infections latent of resolved three reactivation explanation. a COVID infections response. development or system symptoms criteria and World the In acute In functions with. The another We diagnostic immune some the know another an immune exhausted cases, to now without on after least new surveillance lack of continuation routine viruses are believe patient at or infection of exhausted immune months the
hypothesis the long as mechanistic NIH. the is Our task PASC we persistent disregulation has in of This what for viral or hypothesis leads at on reactivation inflammation system, to suggested working force the that refer consistent initiative researching, to recovery been stands Recovery recovery. the the by symptoms is to late further what with immune COVID. enhance COVID
investigator-initiated fibromyalgia, reactivated under and related an advancing treatment including that and hypothesis at and the for a investigational viral herpes are label illnesses. associated unrestricted Bateman some of by study as symptomatology involved single the conducted Virios. excellence, Center interdisciplinary This viruses of by with COVID the post center genesis of syndromes Bateman provided an diagnosis served long Horne open center, fatigue grant disorders, ME/CFS, nonprofit is a Horne least chronic
data that showing flow results given patients let X walk through Horne the is from shows some of the of through Now for study. Bateman me known as what's study. the diagram the Slide study the this a that, consort
for City were treatment So screened recruited of from Lake Horne recruited monitoring Center XX either Salt patients They the centers internal Bateman they long-COVID advertised their the are cohort patients in patients study. own or area. that from other the had potentially eligible they
celecoxib. that are were were the clinical assigned receive the duration for and XX XX for into is and not age, Those as the the combination. XX patients and known control treatment with were were enrolled And valacyclovir Of assigned Val-Cele those the trial. to gender of but eligible science patients -- to those receive treatment study were XX, group. the did matched of disease, a group match screened
are the The XX that study due terminated noncompliance the related possibly by with XX weeks patient XX and to study patients treatment for adverse withdrew investigator study. events treatment patients the the one was the completed all control group the protocol, One of treatment. to completed from
in study to reduction fatigue known developed fatigue how weeks. Slide the as physical an time. The that complete fatigue feedback doing overall at change XX visits measured various three, It baseline and NIH with is fatigue The over It's And their please. self-report the Promise their fatigue, from fatigue was The patients. we was provide patients point on in instrument primary believe endpoint aspects over starting clinic is they at mental look something promise by these of measure that NIH value. the fatigue their a fatigue. in measures instrument. or is a this
saw we patients was receiving of three Val-Cele what fatigue on points X.X XX scale weeks to had promised meaningful. clinically scale, of that the combination to and statistically after meaningful the of their is four the considered fatigue a be clinically on And the treatment in change units a reduction
previously, whereas statistically point in level it's I their a reduction X.XXX, real had fatigue standard level, over at weeks. as said and meaningful. control the was than their group That had So of group a fatigue XX change in care significant no pretty or the much also XX seven clinically the they better
they benefit is this and from. could So really some experience patients realize getting something were
slide. Next
is Another in don't to changes used going blood reflexes pressure lying not important to down intolerance standing to sometimes is we symptoms study in work the as standing in patients we a from sitting dysfunction, the faint. blood Orthostatic you that to outcome if flow those body dysfunction, -- your a goes measure autonomic a common ME/CFS related intolerance. or this normal patients, in finding long and when event to patient was COVID get you're when right brain. is compensates are autonomic for have maintain to quite and orthostatic And
get get changes sweating, pressure and just in don't These tunnel related feel rate, get can You are you dysfunction. can to heart you vision, right. blood orthostatic you
And really long as instrument what limitation which or and orthostatic which And in what symptoms, symptoms. side measure, domain, or looks these impacted by are effect a with used there's so measured, COVID, see since patients we directly domains two at can't measure this that common these an measures we activity you this there's symptoms. symptoms orthostatic there's can an domain, do we
this over was the saw time. on worse improvement significant shown the bit scale left that the got on points symptoms the in Val/Cel left actually group patients And this applied on the a the a nine over on in graph we study, combination. all little control of to statistically And --
So statistically significant. that highly was
whatever. on you because versus, longer got you're right had down, like on that worse, we going feel an that group this again, activity control lose improvement seven And on the and statistically fall again, is symptoms was domain well. can orthostatic a the worried And as consciousness, you over the the Val/Cel significant things point to limitation you're or scale the no about is do
hadn't these finding and which Val/Cel and of both to important us. was We with hallmarks was was of by an approved treatment. quite we are this long this new measures before, -- So that were ME/CFS COVID both patients this the found seen combination, that
X, Slide please.
T-score fatigue clinical to combination already the summary Val/Cel improved. So measures control this all here's that some small at the NIH that showed trial. comparing PROMIS XX in And of effect the group is was we've outcome the showed a week this
was So the fatigue these with primary endpoint small of numbers. improved statistically even
as scale. home they at on as fatigue to reported effect XX fatigue. we they its measured the a predominant patients zero weeks scale. fatigue no at on the XX improvement anymore I zero doing scale, not also as worst every the and through have XX That's XX to well The this were also survey, completed PROMIS well, zero a possible this same We home fatigue. was, were doing the scale scale. time, weekly, what where They onwards, XX zero week and a a over on At to saw pain as fatigue and
did a weekly as well. improvement their in self-rated pain, pain on We statistical basis also see
and they global scale, at you I'm it the with seven group. how impression one Patients is means, XX say, doing reported visits, two seven where and that control scale, end the are health beginning be. where both of on they're than patients XX patient statistically We the is also We and to better results is opposite health, one doing think, best overall zero men I’m asking had worst overall health. completed one two those two scales patient the And doing general intolerance showed was them orthostatic different point. well scales, different so completed study a got since that means impression I've really poorly, really the global could statistically direction possible my significant treatment clinic on intentionally, at zero scale, the on to
cele hospital XX the it anxiety in week And anxiety symptoms a statistical actually study, domain in went depression this depression a well significant and direction. for significance, for domain And so symptoms, symptoms had the called statistically the we anxiety scale trended towards something group right certainly control. treatment depression and in versus as but was has the also at
From direction and what study So that was encouraging saw most tolerated. the combination events was in them. have a valacyclovir going in significant the combination of generally we we consistent is terms was with celecoxib. cases. common know was what right we of in about which doesn't really valacyclovir in adverse all It safety toxicity And celecoxib and any all profile like away standpoint, any well safety of adverse nausea particular. very event, already far and there's with that the effect statistically endpoints treatment a most look and known And
Most treated control group routine related to patient to or There care the as valacyclovir was which study, adverse no we in the common and adverse event I serious the treatment. adverse pain. in only muscle were events mentioned, due events, discontinued one headaches possibly were and had,
the steps. me that and with next So X Slide summary, let outline go to
this combination. have filed method we a for of with So use long-COVID patent treating provisional
would good for And and orthostatic we have Focusing a on quite if while. very issue, that coverage should patent fatigue intolerance.
proposing replicate these to Horne using double-blinded, follow-on are design. the We with a essentially study Center results placebo-controlled a Bateman
are And year. request a ask plan later anticipated a their on preparing meet long-COVID with with this FDA we an to also meeting with meeting a for FDA pre-IND the and for indication guidance the development
combination were well-being fatigue, patients to length long-COVID exhibited in routine and cohort would illness, clinically compared pain, and gender, by general related matched diagnosed age, weeks who with treated of the dysfunction care. female say improvements to who were autonomic of treated to for significant that of celecoxib control XX I a that, with symptoms as label female long-COVID like then summary who patients So open and statistically and with valacyclovir in were with
treated general statistically and significant main status controlled cohort prior the were the health The and symptoms given that of long-COVID-related enrollment in long-COVID particularly two was symptoms improvements for this encouraging to study. duration years in both
the I and about during further would session. plans answer our analysis our be happy data development questions to Q&A
Angela and our the to Treasurer, Finance our me financials. program to back Walsh, Let XXXX turn SVP discuss QX of Angela?