Dr. Andreas Muehler
the last Yes, our present you. received top very MS that from to X Thank line data Phase trial happy late relapsing-remitting in we I'm week. that
XX reporting Phase used population option extended the XX as XX-week blinded patient out the with IMU-XXX, to of a XX placebo. treatment and patients XX IMU-XXX, well had which blinded we're the study period line X top well arms is milligrams in treatment as trial completing period. period for the enroll This randomized introduces once-daily After today, which slide in of XX-week safety as the randomizes to In the either as points as of have of patients with or dose milligrams summarizes treatment intended patients at relapsing-remitting extended currently were is as treated were treatment period, this data active slide treated XX this IMU-XXX. long-term IMU-XXX. IMU-XXX. patients for as So trial of treatment as observe XX and milligrams into well placebo design and this one which XXX two patients XX least The study study. ongoing, the an study This were received of is with to MS patients this a here, total which and period drug XX IMU-XXX milligrams years, to X.X of with the up well graphically study
blinded discontinued patients treatment the XX-week treatment few period. during drug very As
This all was data. seen XX, of to key baseline MRI, counts images, the of used to blinded dose MRI XX, lesions, data base avoiding This of come an XX Basically in intended endpoint being secondary lesions MRI of were TX analysis detailed study. the of to MRI also using were IMU-XXX for points summary primary and MRI and the the endpoint detectable and the new total patients on compared all will examinations endpoints more milligram cumulative A back use XX MRI the to a the blinded baseline the MRI on and or to based primary refer of endpoint it the or end XX-week the baseline XXX This points study double active gadolinium-enhanced to MRI We milligram MRI. as the of primary by unique reason characteristics a secondary The these the a TX-weighted the whether IMU-XXX treatment treatment number compared lesion slide combined week four was on. the reader. introduce CUA period. analysis lesions. independent with secondary of key study discontinuations for the counting. performed XX were The the central MRI at analyze is randomized key for This contains lesions X, slide examinations completed patients. later end
let's start the So trial. data efficacy on this with
dive with bringing the data as XX% primary of to end that compared news available lesions So suppress The that into an were has happy weeks be report currently key treatment we are XX that line significance, to endpoint milligrams let's over but of I'm us. MRI high CUA and deeper and are average one this with the top both met secondary statistical points XX to primary analysis placebo. -- to shown IMU-XXX excited
analysis is example, statistically end the CUA of lesions The over illustration. new show placebo secondary the an of general and only analysis MRI X.XXXX. can point for as same an You descriptively XX-week MRI patients XX -- statistical new again, that showing, with of at period. The points example IMU-XXX, three placebo the IMU-XXX statistical will compared lesions patients guidance milligrams than milligram regulatory analysis MRI of numbers milligrams XX placebo purposes, analysis that that time represent are while a same a of this in primary agreement XX illustrative to X.XXXX. of again prescribed showed just less XX placebo over significant for us the analyze -- analysis XX statistically for with showed with a trial lesions having end -- Taking XX XX not the group IMU-XXX this new of X.X while these lesions -- milligrams priority that practices. preplanned p-value my trial means superiority picture of this IMU-XXX Patients treated period. showed average average this key scientific -- points show XX-week over end MRI only lesions actual shows for other as All dose analyze XX% significant and with milligram the main patients the in for the placebo. a a suppression p-value The of established The as to plan. shown MRI
some trials to just the data the of suppression the slides. Phase upcoming oral relapsing-remitting first-line other lesion available provides medications this with patients slide commercially in point of other general from multiple for This MRI light on illustration currently for sclerosis. for X out relevance So trial
we including that in the very the the between first-line are predictive high The Immunic are compares difference an on effect slide XX meta-analysis, reduction and favorably between on used is the IMU-XXX reduction, MRI effects next point in MS. MS. intended is Phase a oral data -- relapsing-remitting relapsing-remitting published often on trials medications in and MRI of suppression had that of A that large a association trials lesion there's MRI lesions slide. of robust lesion other point as same comparison X trials Although of some show treatment factor. the established of out, that shown with to difficult the relapse relapses to end clinical believes usually is correlation
gadolinium-enhancing at points the the cumulative weeks placebo. end looks the now top to we treatment of slide and Let's the new related MRI gadolinium-enhancing already part lesions weeks, data. numbers points patients Those any on advantage as arms show end trial. additional X relapse- data over XX some have lesions. of Phase number This XX that continue gadolinium-enhancing of with available summarizes of secondary over This line [indiscernible] of the Immunic the IMU-XXX recognizable without numerical this of over lesions slide
the are than usually relapse-based objectives would not relapse-related trial. make of to this population than follow-up [indiscernible] to of was occurrence events new some assessments. that which powered with relapse period Therefore this for was larger say endpoints being the frequent assessment trial. lesions, We the weeks to much primary requires As patient of XX much MRI need be a of with much anymore longer any less studied study assessment of the
those study, in indicate arms. and a less and detected was relapse limitations relapse would the IMU-XXX more already that rate patients despite signal the treatment free positive However, of
X summarize and with take observed the statistical in patients. results of already end have top limitations opportunity IMU-XXX what related relapse-related the such signal I we and Given Primary significance. --regarding Phase such data short pleased secondary like to efficacy duration endpoints. line to of were the we're met extremely relapsing-remitting related MS now small of would as this high the from with trial trial,
noticeable based also secondary on equal on of oral efficacy first-line signal very and dosages arms this IMU-XXX and endpoints a of used treatment favorably trial, IMU-XXX. lesions endpoints, numerical in that and other those inhibition XX are consistent to based the Data fashion other We provided parameters MRI and on a and in including also MRI there's compare benefit XX to milligram encouraging placebo. medications. relapse-event as both IMU-XXX other for All compared believe
think I So to let's be now would continue which safety, interested on you also see.
adverse higher rate events shows slide There with the emergent not first adverse highest IMU-XXX The for did the any are XX treatment and doses trial. adverse no show treatment arms in events of in were of trial, adverse here. only emergent of three noticeable There's event events serious this serious listed higher IMU-XXX rates The IMU-XXX. this and for milligrams of treatment those trend dose placebo.
more deaths in low X.X% on-study endpoint milligram adverse an were We've events. the XX endpoint This this of XX trial. no to in earlier trial, observed detail the the safety Additionally, important milligram basically already for treatment this rates the discontinuation group. or slide summarizes placebo important dose safety X.X% in and for discontinuation overall dose, the X.X% due for shown
importantly, relapsing-remitting tolerability the discontinued -- profile believe multiple a adverse due that investigator patient to treatment IMU-XXX three adverse this The combined indicator represents criteria. two population. patients either the this and to in due only protocol favorable for sclerosis the More in events, events leading treatment described group here. relapse-remitting in safety of good and summarized also to discontinuation IMU-XXX arms We placebo decision treatment by patients or
done discontinue this that on with it's data -- of As MS. this currently slide patients some commercially illustration and are for again, the from relapsing-remitting some from available first-line these rates efficacy, we provides for oral have medications where the trial same treatment
components to years doses events very events specific previously reported laboratory-based of those detailed has numbers of results as The trial two increased the trial events favorably treatment compare renal arthritis injury. While Immunic enzyme difficult I Immunic with in considered areas the observed. label the no teriflunomide monitored first that presentation in Teriflunomide during done baseline and hepatotoxicity X for of drugs as a these a may enzyme to rates are relapsing-remitting this from following not careful active box patients and a IMU-XXX events discontinuation placebo. and trials and established of oral closely has the increased of as unrelated. Phase events other warning date the of to often rates to label liver events placebo. would signal anywhere need of to any induced patients. always some of has in bit COMPONENT that thorough placebo of a or The for than particularly for But this in this IMU-XXX has commercially treatment renal shown compared how show for also to very its a MS has discontinuation rates periods. there again against liver for the particular, rates rheumatoid development We IMU-XXX treatment of liver also like let's out safety liver liver much start little was active potential a show, first-line XX also group. trial rate and section in program for in and differentiation to believes compare, IMU-XXX been unblinded placebo analysis ago. relapsing-remitting weeks black liver rates in hepatotoxicity, no drug also dive IMU-XXX that the comparing approved trial deeper. on and Immunic monitoring in treatments general, shown of MS between of higher teriflunomide and the MS. Based And for be vidofludimus placebo. in very teriflunomide had a Immunic potential discontinuation IMU-XXX, analysis deals elevations was liver available In when this over medications. particularly liver hepatotoxicity initial point other a medications compared relapsing-remitting in and this event elevations. few the on in for had the signal structurally requirements has
We slide. also -- looked next
different enzyme XXx elevations, Xx, upper using XXx at the of thresholds for normal rates looked also of limit and enzymes. of liver range these liver We
both see As enzymes from you the included both AST can the low. ALT of this elevations major enzymes liver slide, rate to different of very and
IMU-XXX above looks to go for the upper liver no was there liver XXX approximately placebo. as scatter no development trial normal. upper cases But in be There's drug those of of not and ALT, patients, trial Law Xx Hy’s placebo. summarizes [indiscernible] in important of hepatotoxicity confirms very of rate This [indiscernible] and were few This for demonstrate as EMPhASIS are compared again, bilirubin induced that limit Hy’s were total IMU-XXX of so-called also events. shows in slide bilirubin no the The let's more important for enzyme and enzymes limit that signal assessment well. increases Hy’s treatment liver concurrent analysis and Hy’s there plot liver [ph] assessment normal the believes between than comparable increase volunteers for injury. MS patients of representation, one either Additionally, or a analysis of to exposed there Law Law treatment that elevations to and another cases arm enzyme arms that in are to in IMU-XXX. is date. Immunic relapsing-remitting graphical the elevations of this program. The assessment does liver Law entire that Xx There also IMU-XXX
evidence was well-tolerated, of to observed So group. data with data to is -- take results to Consistent profile to safety you through with in general, line trial the In data also be patient was to you population. safety of Phase like would favorable this sets relapsing-remitting of observed comparable of IMU-XXX other trial. -- the here profile the top administration IMU-XXX X populations, of placebo patient I this this providing in be the prior safety summarize related further in
events to was increase available placebo, we of in the rate any that that of first-line in no that favorably signal seen relapsing-remitting as renal have oral -- discontinuations IMU-XXX for IMU-XXX MS. low hepatotoxicity compared was elevation -- compared already discontinuation many and favorable to enzyme liver believe be in observed. There profile rates of summary, liver very there's a In a treatment medications or could observed. We and no other safety
I an would give development relapsing-remitting think outlook program MS that you IMU-XXX. also of I you be for the interested overall
top beyond analysis in X So full you data ongoing of are available these line Phase currently full. the is to the presented that trial that data
are incidence conclusions thorough low, change more monitoring know expect From in the yet blinded was not core the events set. the conduct, already the analysis available. do we the that adverse data safety of we trial the detailed Some of and at important data of any not of
we data is early Phase this the September. the ago. has present for preparations this to trial to of in already such once continuing full given set data Phase Coordinating started obtain a sometime detailed analyze X scientific However, X are an Investigator more And X of meeting Immunic for potential and trial expected program. upcoming we data, of availability program preparations at Phase
more statistical was regulatory I very back was the you. available, guidance provide once I'm data will And discussions to as intended Phase have and with well experts, to that completed. experts, excited able handing data We these been present on program to X clinical is over full Daniel. as authorities I
