morning, our clinical ask pociredir. milestones good everyone, us recent today's Alan upcoming then updates questions. and finally, Lisa, losmapimod the progress we'll and for to a to I'll brief call with of call. you, we'll and Thank our after to great. review And for We've taking all joining financials. two into on and pipeline, quarter you second your by conference introduction, organized you thanks And provide for segue our That's end stage assets,
to am compared top our I track end previous of trial report of the are Phase REACH October to we guidance line fourth on to happy that report III for the quarter. data losmapimod of the by
filings the In outside launch potential States. continue filing parallel, point, losmapimod. the with important we this we losmapimod As out commercial the inflection toward United talent of of for in build preparation working U.S. are launch and and NDA we as regulatory Sanofi the advance to and prepare we for the of team add
FSHD as this the capabilities losmapimod we on this commitment for the development or As expertise high in collaboration community. license address best in facioscapulohumeral short, with partner outside forward world. in May We of FSHD commercialization and Sanofi's agreement collaboration our of Fulcrum's neuromuscular believe for selected Sanofi U.S. commercial FSHD the and around muscular in look territories and of combines dystrophy, the the for for all year, we need with losmapimod a our patients development the announced possible of delivering to we for markets to shared deep regulatory unmet Together, reminder,
Let heterogeneity which of me relentless of that muscle extremity cell of is many of is patients inhibitor with muscle upper death estimated function of of degree time an XX% a resulting while muscle FSHD, as T-XX in muscle losmapimod, FSHD. small selective become in there onset wheelchair in a FSHD, spend impairment that relentless and transcripts and expression disease And molecule bit is U.S. means patients by the more its you bound. in loss but prevents progression patients of a DUXX thus which know, significant function slow oral of approximately mobility. year-after-year and this function characterized loss alpha-beta many MAP An have and downstream on kinase inhibits the XX,XXX
it's and remind important for to used therapies that no approved no there FSHD think help I to everyone currently patients. off-label these drugs are
registrational our our which called spoke III to Now trial earlier. about let's attention turn I REACH, Phase
year, U.S. of in REACH total a in of a be is here As a and last both trial U.S. enabling September reminder, patients. we the geographies. Reach XX-week enrollment In completed III intended ex to registration Phase XXX in with
agreed on is the patients. favorable which to year, extremity our daily study reporting June or benefit that As the on population. of to of specific of REACH the Research in encouraging the REACH study we and our to using International the tolerability Based are baseline which this the Congress mobility function clinical are outcomes upon report and ReDUXX time are range Phase at collaborative in of XXst the Society motion population and line Annual perform those a FDA, presented assessing similar sensor indicative in Building characteristics the further the FSHD at to observed to Group II a FDA RSA, quantitative RSA in the of technology baseline motion ability REACH specifically the progression. that with is the arm pleased for activities area correlate and endpoint is with clinical has the living. severity to complete meaningful trial, study is from or to reachable change XD workspace assessment disease of extent change measure a primary relative evaluate I'm is shown been upper and of and the shoulder RSA interactions the ReDUXX at muscle of activities on COA track of assessment, top we data. with score surface
We in whole body endpoints REACH disease Impression a Patient Global dynamometry secondary muscle MFI, measured or for include pathology by PGIC, key of shoulder MRI, short. Additional or marker believe quality-of-life help of Change which the of fat and we deliver and infiltration first is treatment for FSHD our strategy questionnaires for care utilization payer launch inform implementation begin will measures patients. to that as preparing the self-reported health a commercial
phase of now patients. for trial enrolled of are towards XX-week progressing the the We the completion all treatment
line for observed was those open-label of FSHD. is the who the of drug. Again, of on very extension believe therapy II for delivering first-ever XXX high XXXX, in enroll phase patients. XXX As need top the indicative is study which to FDA-approved the similar out by the those of are the patients patients all or XX% or treatment of receive percentage June October, phase, of completed open-label XXX will chose This XXX in of step we Phase track FSHD patients closer Part patients the into to -- data we opting unmet of one report high the to of what B, bring XX-week the XX, with clinical and in to move us our end trial, to which
hemoglobin of is therapeutic people little a impairs making approximately which in that cell quality cell relief. clinically sickle or is for elevation treatment a U.S. cell inducer for pociredir, talk disease, hydroxyurea our has people sickle for most of million sickle rationale on disease transfusion, the disease hematologic only blood XXX,XXX inherited X.X with let's worldwide, for disorder severely medications oral of the of symptom one HBF about the blood pain cell lifelong that validated Historically, standard life fetal approximately bit the and treatment a The focus nonmalignant and potential diseases. prevalent patients HbF disease. sickle Now included
symptomatology. recently, progress editing there broadly gene an enabled a scientific exciting option the and sickle therapeutic cell is that we high believe of approaches, has While the of approval need remains for unmet more therapeutic disease protective advancement oral
small As a believe pociredir address inducer molecule has potential first-in-class we to the this unmet oral HbF need.
we progress. now Turning to trial, Ib make to PIONEER our the continue clinical trial, Phase
newly activation many we longer it have are with are here the that times, lead sites our of sites the both Given in of expected. narrower well long the as which activating than taking is U.S. inclusion academic criteria, together initially site outside U.S., as exclusion
everyone data to to have XXXX. in with study expect share We
dose, prior X in involving a building Cohort pociredir with oral We community the pociredir by at evaluate the patients Phase months. interim Both XX the on option inducer believe in XX of meaningful a the that look the a disease for forward As daily key community. which to encouraging the trial EHA disease, June were were expected living the the conference a results into of by received well differentiated These translate obtained clinical significant Ib in once-daily potential approximately addressing will to pociredir very once reported each. Cohort followed demonstrated XX-milligram with HbF that recently fetal total unmet a sickle an enroll We patients improvement at in to has the data hemoglobin are Phase magnitude increased clinical sickle also reminder, cell cohorts at hold disease months of as Ib priority Madrid provide the and for for XX-milligram X that remains medical and X dose a could trial dosing us. people severity. duration cell X to of therapeutic need the
business, Financial through the that Officer, Alan, Musso, run over update let the Chief it you. to now financials. turn So Alan to over to me our on with
