and Thank you, good morning, Glenn, everyone.
recent a randomized, root in growth met the The sham as As pre-certified for milligram we of millimeters growth square as over for group, X.XXX and months of value XX purposes. X first two reported double X.XXXX pivotal P with to that control with Zimura group, believe X.XX Zimura, Glenn the transformation screening mean controlled trials our factor geographic serve sham millimeters registration in a a novel with GA patients of corresponding with compared of was in the reduction clinical compared relative reduction CX the XX% X.XXXX Zimura mentioned, dry reducing complement group. P milligram the AMD of can we sham approximately atrophy X each trial XX for for corresponding the control endpoint an as months the to masked, its rate primary group, of in that value over corresponds inhibitor, rate to This group.
statistically These were for both significant. groups data those
data Zimura for statistical from percent that patients efficacy milligram Although of less was on in tolerated baseline corresponding for preliminary not the administration. was X the months the sham analysis, Zimura pre-specified for the over part suggests group. growth data well GA of month groups. group prescriptive analysis generally treatment those to relationship XX Therefore, indicated response across milligram from average, Zimura XX Zimura receiving control X than was overall
related related events, increase the been clinical investigators adverse the no the of reported Zimura by have no study reported reported detachments, from been no ongoing pressure were cases ocular Zimura of event, Over trial, trial. Zimura and were attributed adverse months there inflammation no first there no XX to related the discontinuations Zimura eye endophthalmitis there trial. no Further, of retinal in no internal this have serious in and
fellow the complement XX group range fellow the in X.X% trial, remains in first eye been coronary controlled vascularization trial in patients acceptable observed GA. of X eye XX development the milligram X%, the and as is what XX patients and within an the first the milligram X six in or three the inhibitor study and The months for or believe the incidents the than untreated the Zimura in patients was was the compared trial point to the incidence for of is rate We receiving ongoing currently reached. During group until study in the another sham untreated months patients during lower or the eye X.X%. Zimura XX has time month X.X%, literature for eight patients CNV reported was or of the sham eye Zimura of in group of
of we advantageous may We based that population and incidents believe potentially we and competitor on to safety the CNV seeking Therefore, Zimura, safety may that CX. concept double treat. an due part our rate over superior of are have of patient and in of the CX of lower we blocking believe to profile profile in Zimura be profile
may more subsequent complex to attack in relative memory similar observed action but the that important go The cascade to lead compared level lead believe could a may immune may blocking leading retinal provide to sham into explain is to that therefore and this detail our degeneration CXA similar like superior potentially arms. CX it part slow CXB of believe cell death. lead CX we or complex of converging in believe mechanism we role and on three consisting formation, CX blocking cell CXB. We trial, to we CX, progression inflammatory inhibition, both the complement CX GA. and of down we pathways, profile. as information would innate of the prevent why the may efficacy of believe that safety We validates formation that complement blocking potentially efficacy prevent for CX system, CX, inhibition a to may the I of CXA AMD. to and of activation, as by of affecter to CX and and with
for in differences decrease is associated potent populations. based the incidence and research that observed could that a profile CX to and may positive cross in privileged including system loop, have effective CXB leads inhibition. serious with on which of functions such customer in In shown that is CXA as the for know could potential invading potentially a formation compared superior The and caveats and been blocks Zimura all is with has the patient the tool The also as not serving feedback inhibiting abnormal in trial published anti-angiogenic in suggests CX of lower considered vessels. an the thus, explain CXB. potentially anti-angiogenic safety CXA immune trial increase characteristics blocking is design CXA, the are CND currents and optimization be formation CX, blood protect pathogens part patient. With which The in which when our infection. on activity based sensitive we eyes presents is as generally experience, Zimura, clinical complement to trial a organ, powerful with comparisons, consequences and Zimura immune visual infections help endophthalmitis, the of event, from experience the our data it potential of to CX clinical for severe intraocular may CXA against the factor and scientific of adverse to differentiate
in and intravitreal Zimura which NEI and potential macrophages the Our vision CX diseases It that complement than the altered over in I require for may, been appears reported the complexities highlighted and complete Medicine zero to injections of CX Journal of time, broad Experimental the [indiscernible]. CX inhibition, not and in with function in CX to could for trial rate disease, rate current nature experimental arthritic recently We optima in has rather to in retinal to structure that in the in a CX indicated of of interventions literature. play that know reported advantage quote, to clear blockage ablation process the calibrated generally role endophthalmitis of endophthalmitis inhibition Genetic accelerated degeneration want photoreceptor model. modulating of and since potentially modulation reported to for lead than what photoreceptors. this The effects may authors the the the accelerate further due GA gene over are loss. inflammatory blocking higher be degenerated highlights the one in by safety may of retinal AMD photoreceptors was role degenerating exert of literature already and the it expression
off a to CX intact, and efficacy the safety growth, the balance may GA safety the reported be system blocking to in believe similar be on inside of data in want cascade to CX trial date. turn reducing of potentially fine Based we biologic clinical that may to as and well advantageous in for targeting view, demonstrated by immune Zimura compared keeping a profile conclude, completely date, efficacy, and in CX eye. point to reached To innate systems, have been not needs between as the of complement encouraged safety inhibition, one downstream from rate CX well sham, the to as general by appears as
Of cross difficult will designed only properly from to answer is trial scientifically. this and course, conclusions thus trials question future it comparisons, draw
as like baseline trial Zimura criteria more the and Doctor was geographic trial. primary would support change on our GA, Fleming be [ph] gears the paper same I you a of to in described endpoint approval. trials potentially targeting endpoint anticipated a our trial trials, in published as based screening now Richardson as Bruno used by atrophy used at on give a and trial the are would detail Zimura for Thomas fixed efficacies Phase in and time clinical and in XXXX designed the characteristics in design the to GA clinical screening The were for regulatory the X
However, trial a a anticipated has screening size has sample the three screening trial possible A generally trial. than X similar smaller our Zimura trial clinical to outcomes. Phase
levels controlled, lower would should judged study's plausibly more be dosage and benefit, efficacious sham as its not discarded size than estimated the effect current the the in indication. in indicates the if of information be First, experimental
clinical lower X the and estimated significance, level controlled would case differently a relevant the for less than if being trial judged regulatory would clinically XX%, the evaluated meeting trial to only paper more probably be in X not count X for moderate a than if efficacious registration the both trial and a of size Second, subsequent milligram efficacious with compared size likelihood our effect could third, controlled in the the groups if the the the milligram with was sham example, in the more is there trial. certain for as one sham required controlled of as than sham but effect, it effect the was should Phase truly achieved, was estimated statistical more as be GA, is and evidence trial as be information possibly And file groups then corresponding dose approval. Zimura relatively
data believe for we over Further, dry and both X GA about were milligram well As Zimura indicated relevant. groups milligram significant clinically for XX dose secondary top was to generally and months. for Zimura line A&D tolerated statistically the X the
clinical would the As regulatory sham safety this indication. randomized, pivotal, Glenn date based consistent to eventual approval to remains additional in design profile in our safety clinical to controlled that with we trial review, only and subject manner trial Zimura dry on one earlier, to findings demonstrate needed mentioned be and sufficient Zimura believe observed assuming the regulatory to efficacy support of in GA and secondary AMD the that
some living goal to them maintain task healthy to allowing of these the in of or as for the areas, down and vision, of perform slow growth continue as degeneration patient preserve living is over our therefore long the an trial. is GA Therefore, atrophic eyes. like is retina for would difficulty baseline loss or GA granularity in primary over In light, the our to role geographic characteristics a This years I location this patient's drive. to in or down patients enlargement stop in which time. their trial degenerative in ends in a growth layers degenerate Now of atrophy such being are the and in tasks, area and daily The generally progresses the over atrophy. atrophy critical provide this leads atrophy, a and of the severe primary geographic recognizing of Zimura In of responsible developed endpoint, or the disease this as condition with both patients chronic endpoint slowing read retinal endpoint efficacy function atrophy you having in to retina treatment daily over functioning objective in macula, and receiving the stop enrolled anatomic area, trial of faces, able vision. time for that the performing function possible. patient vision The that plays
GA reduction GA Based images XX. for then and previous center three on growth In was endpoints that three groups is independent has XX the of clinical a the the each believe six time compare masked indication. of at approval and over evaluated appropriate agencies. to the of may this in We measured months reading autofluorescence in in model points, the by pivotal FDA, was believe our literature regulatory months play communications this a treatment Zimura captured with endpoint trial change by the GA predicting read of with measures an this [Indiscernible] of were preexisted a baseline model we baseline, over indication primary rate is GA is the to month growth by repeated over that for fundus generally images is XX arms role the trial. It an the other. by utilized this in The rate of accepted that we size a mean rate the that time. that reported points: month and the time our
treatment based in example, clinical than data can is And XX-Q that are the date, to is arms the based found were mitigate performed. the size baseline further balanced, arms. on data over square taking calculating trial, in the square we this our GA, the received baseline accepted believe size. of GA size stratified cores across smaller the impact growth. on GA cores when the It was generally GA based have baseline treatment and the is be well GA size in growth root on Further, larger the imbalance in filed we For these reported time baseline GA. morning. side size to GA the that and field between the may GA a well to size impact to change for in In our important Therefore, arms treatment of an various the stratified various was on slower transformation the the the the baseline balanced the grow of mean it of mitigates the on lesion for that GA literature and GA the size root prevent
based trial on based data connectors baseline vision and received we pattern. balanced. above, baseline indicated GA the As date, to in baseline The on have our patients autofluorescence are size, the baseline that were well stratified we believe
analysis the in We details sensitivity have also details discussion, baseline are provided inclusion including additional characteristics in the clinical this be XX-Q a more further of morning. our clinical the regarding patients and trial can testing and exclusion regard to comprehensive XX-Q. criteria, filed in the this from found Further, trial the details of enrolled statistical
GA observed does acuity GA believe was It this a is from to not in probably visual we center have may on have lesion not the with the have excluded the this since the benefited rate. would these to in fast participate We and impacted that significant point faster disease. validate patients Zimura the at grow corneal patients trial Zimura the cornea growth important the a slowing potential growing GA out highest, involve is in and patients treatment. further may Based literature, the the for of population of that GA trial in we in whom
developed enroll continuing eye our We keeping the controlled, modification study our who plan that trial of and the randomized, ongoing the clinical during have have potential will clinical in patients masked sham exclusion with planning CNV treating in first XXXX. the of quarter inclusion pivotal currently pivotal similar to patient of begun are The trial first trial trial. and the double second
points design. the months continuing trials will to efficacy first we with specific time you for collect XX In and will XX a use safety future, the and our upcoming followed patients be more near will trial same our clinical with total to of as pivotal last over details months data. We additional end and regarding update treated
rate upstream. milligram as rate X sham other groups X increase, differentiates an inflammations, a impact its Zimura compared for complement AEs, sham blocking in Zimura zero results of related for further events, in of zero of clinical In no to in superior GA serious incident advanced believe IOP of for with of earlier The respective both endophthalmitis door controlled on significant and milligram rate of the CNV a to to the lack GA as inhibitor the the stages in the dry observed conclusion, AMD of of open AMD trial compared Zimura application itself. this we mainly that may combination form disease, dry zero potentially statistical Zimura relevance Zimura the adverse and compared potential efficacy and related of Zimura induced
We are this explore results November not planning in presenting patients to majority could to impact X in XX options Zimura them. New these to look which discussing opportunity, here the Symposium do any We our have exciting currently who a.m. upcoming Wednesday, potentially XX forward from and available treatment AMD of more detail to a.m. in on York.
I like Dave? to now Dave the would turn over to call Carroll.