you, Nick. Thank
is demonstrated whose Nick study. therapeutic as the course, to pivotal in Phase a is Of benefits SIMPLIFY mentioned, of the purpose confirm momelotinib X MOMENTUM trial as previously
you of Let MOMENTUM me a the about the number key study. tell of features
Center Chief, University Section the introduce in is studies Houston. a Neoplasms, Medicine Cancer Anderson of of world of Myeloproliferative Srdan The Texas Leukemia, at me Cancer let Verstovsek filed. MD Dr. Srdan renowned Chief First, in for Investigator, the clinician Neoplasms Myeloproliferative Division Verstovsek. Dr. Department scientist is
And principle peer-reviewed with recipient trials the patients been testing also than over therapy field. in Myeloproliferative more prestigious it's myelofibrosis. of novel for awards the has Neoplasms, XX for investigator the he's forms clinical of including And numerous multiple XXX Verstovsek manuscripts. Dr. published
investigational agent investigator. the including involved agents myelofibrosis, really the and standard in approved was treatment the development of of Moreover, has most for been development the Verstovsek ruxolitinib of he of of U.S. which Dr. the lead for the care
and record signs following. and a may of has the In an particular, the since but momelotinib he for Investigator, control has some doesn't as gone it and to development the the XXXX, progression. prevent Clinical on involved back symptoms been Sierra Srdan Ruxolitinib both of to disease in time, previously advisor as stating
been that majority quality any And a is agent improve and life of lastly, momelotinib, aspects has symptoms patients to possible. Next, JAK unlike disease. great inhibitor, of on the the of their the The spleen, another published leading extent cause is benefit three anemia to to establish to all other control need response anemia. patients loss can of of
to So many clinical the prior expecting subject, trial. contributor MOMENTUM doctor in myelofibrosis momelotinib of other participated many to are with leaders addition, success in active of opinion key study, the notable have be whom we
Dr. Alessandro to Vannucchi, among Reuben Francesco We Passamonti international momelotinib Dr. Dr. Jean-Jacques standing These Harrison, community include believe support Claire interest and Dr. Mesa, clinicians Vikas Dr. Kiladjian, broad stature and that is these and testament to the build. others. for the the continues exist myelofibrosis a in Dr. Gupta, and of
design? been demonstrate about designed to in In clinically the compelling study three brief, order what all actual MOMENTUM meaningful and myelofibrosis. statistically across of outcomes has So domains
symptomatic face, First, alleviating very patients patients a life burden debilitating to poor for of often leads the with quality which myelofibrosis. these advanced
cell manifests painfully lead enlarged that fuller the aspects production patients life. typifies can consequence the through. the reducing to a third, transfusions. Second, for addressing all more and In anemia frequent patients chronic disease. of myelofibrosis or of patients that improving helping as in red turn, spleen active eliminating the lives, suffer these the requirement these blood common potentially Many encompassing And blood that impaired impacts
inhibitor. MOMENTUM with to in follows. designed So population an previously order is that and JAK achieve on has study patients focused been approved these anemic treated The outcomes, symptomatic as been demonstrably have
patients were be would either that Specifically, that fedratinib. treated previously ruxolitinib or with
myelofibrosis. and is design. guidelines study an in enroll competitor The Danazol XXX in included appropriate double-blind as it treat ESMO agent anemia steroid will patients NCCN the a is danazol. and therapy observed the in androgenic is to randomization an The treatment
The randomization momelotinib X:X phase. will over randomized to danazol a be XX-week treatment
to Following danazol were that on an momelotinib patients to for period. treatment treatment able extended who randomized treatment to switch randomized phase, are
important to it with drive a the to and and that it's sign is of momelotinib productive views on constructive towards process combination FDA, their Now, optimally the reflects approval. dialogue potential the of of MOMENTUM stress how
would the study the total the for baseline endpoint to MOMENTUM FDA both is momelotinib inputs, in obtained showed reflects symptom treated this improvement. in expect which studies, from week with and on study see week cohort, data, in on of we burden the based patients at simplified that based we Specifically, for endpoint improvement noteworthy a XX to for symptoms XX. very This primary the symptomatic consistent
highly endpoint Importantly, this is powered at primary XX%.
reduce unique to transfusion burden. The benefit number in of or eliminate MOMENTUM address secondary its endpoints and momelotinib's anemia ability
is all measured with XX. occasional specific This For was transfusions powered after relevant at frequent, rate need next chosen is including or it the with be myelofibrosis week no as endpoints instance, for blood independence and at patients, symptom transfusion XX%. is the endpoint those those to improvement
from measure at a will several independent, including relative these endpoints in measurements to conversion the XXXX December ASH the being transfusion Other including we anemia transfusion the benefit, SIMPLIFY-Xstudy transfusion the data measuring We endpoints of anemia benefit ways, related focus in of presented as odds Conference And and detailing of the of dependent in on on MOMENTUM independent variety anemia burden well. study. novel cumulative rate.
response splenic also XX. at measuring we're last, And week the
had the SIMPLIFY-X endpoint is non-inferior today head spleen benefit. comparable patients response demonstrating the endpoint As versus And The versus momelotinib response XX%. primary the ruxolitinib. two agent to JAK at naïve ruxolitinib been met head of is reminder, only a in agents the have to that powered splenic momelotinib rate studying study, spleen that inhibitor MOMENTUM in
three that anemia, message is therapeutic symptoms, for across success. the benefits the disease, study for confirm main of enlarged spleen So to designed is hallmarks of and momelotinib the that the constitutional MOMENTUM empowered and key is
being in will the XX true of MOMENTUM The a approximately enroll is period, then estimate patients a study. status expected QX XXX XXXX. the following that and to XX of week that for treatment randomized it top as data trial, is As line months global take conducted
pleased ASH in study had activating of officially Pacific currently in XXXX Sierra region. the across Europe and report process the America, We're launched. the sites Asia North was that December in to at
study making with with country basis, within as conduct by as pleased good countries. specific today. those the regulatory are country conduct an across investigational very individual study We the well to approvals sites progress We're the on
see these We mature XXXX. positive this as expect to cadence operational through continue activities
Everything remains track. on
QX to XXXX. topline mid on as around data enrollment based We our current timelines complete in XXXX. And expect are expected of mentioned,
been Track FDA. granted we in May Fast announced have status we the by XXXX, As
take with of filing certainly people QX opportunity for targeting are the the advantage XXXX. So we communications FDA. frequent Overall, a date of
early a make regulatory As could the approval as keep we'll U.S. we potential as assuming priority for as informed progress in XXXX dates. this everyone QX regulatory Obviously, be result, review.
going to I'm turn Klencke. to Dr. it over not
<>
Mark. you, Thank
our on positively. is to throughout As just And top expect ongoing to we until you progress time line year. continuing momentum it's the of look with trial can to moving provide matter see, updates forward have we forward a data; the
As company. the here, near and is enrolling we've of term stated focus MOMENTUM the
Momentum However, that as we to totality mentioned that remember be data the plans SIMPLIFY-X of drive and will earlier, confirm the clinical submission which Indeed, studies, in to and reveal trial it with it's MOMENTUM will have data of a trial. to the that benefits. the our the that of from includes in the verbal regulatory momelotinib we from important designed we breath SIMPLIFY-X previous benefits also a data addition of the the observed array positive momelotinib positive unique
now. that data to some XXXX flavor momelotinib. of with and disclosures flow clinical a XXXX emerging these plan our having from Towards a anticipate throughout prior of end, of provide we I'll experience robust report
critical asked against as potency pronounced comparable targets occasion, potency. That returned low all of inhibits, potent a momelotinib as momelotinib the in to & ability you profile. three you is, selective nanomolar this to we've features possessing JAKX clarity underpins it and momelotinib three known minutes. may but for against of as been the three question address targets inhibitor ACVRX, ALK-X a have hallmarks does is few to a that components myelofibrosis. on it has key literature, in sometimes As the ACVRX, these momelotinib ACVRX, of know, inhibitory ACVRX, I activity the of JAKX JAKX, and biologic just And is JAKX, ACVRX
one of is safety an trial exceedingly momelotinib studies across with treatment outcome of data is myelofibrosis conducted. efficacy and a the more in been and in the all treatment consistent have patients This treated XXX momelotinib has aggregate, reminder, remarkably rich comprehensive than for sets myelofibrosis, As most both field shown these in effects the that of database of with there to-date. clinical data
This of continuing to really the cumulative lack full of patients years these these quite dose today remain of with majority benefit, patients Many the dosing. durability the and vast are momelotinib. and of therapy benefits, momelotinib underpins toxicity. continuing long-term even to tolerability The on continuous daily on six, out few the responders drug the still of initiation seven, eight receive since of nine a
direct than on up conducted comparable ruxolitinib available or a includes myelofibrosis standard to JAK with inhibitor The studies the population and treated the data inhibitor both the and held these spleen then SIMPLIFY-X clinically to SIMPLIFY-X assessment of X success benefits benefit, achieving endpoints. studies patient existing comparator momelotinib in of anemia In key were multi-billion previously first dollar encompassing symptomatic and Phase endpoints commercial and in which variety a two shrinkage superiority ruxolitinib is of clear the JAK scrutiny clinical versus superior across ruxolitinib naïve, more head-to-head care in [ph] which respectively. enlarged
myelofibrosis. in we of Recognizing prognostic data and benefit to a breadth view of the that SIMPLIFY treatment. disease common totality, scales does high SIMPLIFY-X in overall represent aggregate, continuum ruxolitinib. reflect assessed and the of utility believe demonstrates SIMPLIFY-X these used momelotinib intermediate patients greater of a with And survey patient by clinical than and as broad this, delivers the triage unique data our risk clinical support a myelofibrosis breadth
approved. in a As potential the assuming important this is of role the momelotinib to disease, treatment play such, drug has
the Of course, and it that differentiator myelofibrosis is the key is progressive momelotinib’s agent. of ability of address to a chronic anemia
of dynamic by increased A anemia, frequent decreased is serum peptides hemoglobin. the characterized develop significant of many blood cytokines which high process and found of The anemia and of transfusions. anemia myelofibrosis inflammation, levels decreased along proportion becoming with on with inflammatory in a typifies myelofibrosis iron dependent complex patients
dependency of Dr. Verstovsek "Anemia the one alluded commented need. that has this Indeed unmet on of quarter earlier year Mark that of domain, area transfusions. That's problems. the beginning major a public to they half A noting these important of one therapy, transfusion. And in required of major transfusion is prognostic almost Anemia already patients factors." are after at require patients the and
made hypercatabolic of major in myelofibrosis determinants overall Drug the JAK progress quality the been life is and splenomegaly of error has factor prognostic and survival. a negative symptoms negative in remains key and treating inhibitors, anemia related the untreated of
inhibitor dependency. unique of anemia clinical array Momelotinib benefits. anemia immediate an Currently demonstrated a evidence they transfusion and thus contrast therapies and are approved in by hemoglobin, occurs additional exacerbate the driven ACVRX inhibition and anemia in and sustained by benefit benefit myelosuppressive mechanistic of as via JAK an this has unique and increases and
why ACVRX of and resulting a and alleviation hepcidin, myelofibrosis restoration in it's ACVRX, and so important hepcidin. increase inflammation why in such this attractive iron perturbed leads of But to in anemia. increasing myelofibrosis, of and an to the leads production and iron-restricted is homeostasis, cell inhibition in restoration dependency. of This of in the it reduction Normalizing an red because iron anemia the secretion an ACVRX fundamentally Well, that's the homeostasis, is a that therapeutic systemic of target? an activity, transfusion
encompass and the in in variety certain benefits independency, anemia this frequency. a from conversion public transfusion marrow to was focus followed demonstrating that were measures transfusion show data studies. transfusion that a transfusion an dependency related treating a simplified albeit In bone domain the assume fibrosis, to of not independence, key patients We of previously, also improvement they
Ruben can Hematology Health world in simplify the Orlando data Antonio, the in Mays that's transfusion at of ASH Director red System, the Cancer in one myelofibrosis the renowned the Cancer He's Dr. last San expert American of blood MD cell Mesa. by meeting analyses a new Center of in Society Center. meeting, a UT and poster Further Anderson December, represented
had including nearly who a during odds transfusions to higher those receiving increased demonstrated treated a requirements week receive of momelotinib, significantly transfusion analyses tenfold a patients with period. compared These study XX ruxolitinib the
ruxolitinib, later these In our come commercial clinical other to likely positioning. words, on to to is important typical initial far according very Nick transfused is and our back This outlines be data, likely receive momelotinib. -- will transfused a myelofibrosis patients less he to they this if be as clinically and
therapy still and a safety active to many studying many simplifies receiving from fortunate demonstrating efficacy consistently the such rich durable with years very data to continue We’re the patients mature after well tolerated have the that set trial, studies of profile.
momelotinib, long-term with plan associated data reinforce unreported previously studies, from continue to robust overall in observed studies. to clinical XXXX, durability, safety on symptom In and as including of and into publications dive the additional data of intensity the other profile simplified dose dissemination both that features well a of benefit, earlier, it’s quantifying deep I spoke the a as we these improvement with focus momelotinib
ruxolitinib can that longer. data couple in In active these median a seven We is noteworthy. this for real of to on believe therapy the to findings, indicate later of world, or the various to published patients range in the months. year patients contrast for Momelotinib’s at most demonstrated be time durability on with stands myelofibrosis XX be years, publications our therapy least
we're of is other challenging full because studies from not periods mild time. generally for the momelotinib, a dose Moreover, full of achieving profound as of JAK to you'll maintain our is maintain benefits from years. out when agents striking for with see it very simplified several of inhibitors, full patients as the as dosing safety adjustments due profile findings cytopenia. to later tolerability dose how necessary ruxolitinib extended A favorable, even year, dose this Indeed, overall remains frequent
naive obtained sophisticated of be -- We’re will reinforcing will population. momelotinib also of symptom conducting, in we for and that on comparable and from analyses simplified and as burden, inhibitor the believe it's we generating that improvement the we're magnitude believe symptom the to the clinical studies persuasive I data mentioned, data JAK that the ruxolitinib
the patients post-talk symptoms the the that of setting, our shown risk symptom ruxolitinib population. we first least and study at momelotinib patient advanced recognizes, on That good, belief totality that's line simplified compared that entire the and intermediate have analyses of improvements not and superior symptom when are better as of one as the is to high so already the across looks by This if in presented two course improvement has for simplified data. that
only will for future community. the we will Not awareness broader these that serve as analyses roll data believe to these out registration new the these of we package submission that clinical to the overall build momelotinib, in contribute data help momelotinib further for
year. data We this expect to publish these later
comments hand to back to opportunity going Nick I'm to it the on now. market
