Dr. Remy Luthringer
Thank you, for Bill, and good everyone. us joining today. Thanks morning,
initiation into recent MIN-XXX, moving is trial programs development. late-stage the now the of Phase three Minerva With our Xb has
is in program of initiated X a which significant for unmet remains advanced roluperidone we need. Phase the end year, most treatment now with negative MIN-XXX, of called trial schizophrenia So medical roluperidone. At the symptoms last pivotal a
pleased sites from a enrolling patients the have been We the US XX sites, have to sites European initiation into XX% enrolled have during prioritized about and at patients with coming am and Europe number initiated. that of patients Approximately of been the of clinical recently approximately More quarter. actively they be US XXX I US. report first will
of the half XXXX. We trial results have from the top-line to in first expect the
As event discussed a life. a which symptoms leader are symptoms the emotional development These recent Currently need as of a drug schizophrenia result symptoms target [indiscernible] episodic, productive to York, the the symptoms symptoms symptoms New and main dopamine negative psychiatrists recent for Negative in for are represent approved intermittently with have positive positive in by focus burden these to during principal to key only of currently schizophrenia. transmission. therapies families for an suffering effect and contrast, Roluperidone ability blocking population. medical primarily therapeutic significant in In burden well patients from our limit available of this first treatments as to society. lives patients lead schizophrenia. [ph] their themselves with under survey opinion is to as patients the in ranked economic stay approved majority the severely patient be unmet
increase weight the but gain, in the negative such symptoms. and prolactin only side system of extrapyramidal effects often the reduces burden dopamine increases not blockade brain of symptoms So, sedation,
So, negative of trial the Phase Phase the parallel reduction and which Xb randomized X patients. The efficacy roluperidone our the showed XX to and trial of is successful X improvement results adult in our milligrams statistically placebo-controlled the XX in trial Phase Phase the findings significant parallel-group study Consequently, Xb builds replicate outcome double-blind safety evaluate and X virtually symptoms milligrams trial. design a measures. aims upon of in in to of Phase the multiple XX-week trial of additional
XX-week will which receiving a from be during continue during milligrams Marder’s of patients XX-week negative drug Patients and negative milligrams period open-label either on XX-week original to point receive extension on The end using placebo randomized phase will symptoms the XX is treatment So, symptoms followed the by negative primary over or double-blind baseline active the their XX NSFS treatment score period syndrome period. factor scale change drug. in and is a double-blind positive dose.
measured The evaluate MIN-XXX, to is fixed Moving of to in of primary on April. mood MIN-XXX, with of Phase over of and trial change score we Xb treatment period. initiation the six-week compared milligram MDD the announced Montgomery-Asberg milligram early depressed symptoms X a trial Scale doses the two in of in as total by the objective reducing the X.X in placebo Depression the efficacy Rating
enrolled scale the of XXX and change safety global The U.S. trial scale improvements sites the using illnesses at impression Approximately symptoms include of Scale. in baseline XX serveries from the objectives are of be of Anxiety clinical and of change using Secondary to Hamilton around patients assessment severity clinically the impression a six weeks Europe. in global of in treatment. expected this and of anxiety
in that of molecule. expected phase, observed screening previous first at profile follow as anxiety Top half levels clinical have period. The post-study with treatment So, Phase are mood consist up that study the design from treatment with XXXX. in moderate of moderate Xa severe with symptoms two-week and double-blind study population adults suffering of results of the the MDD features some will line a anxiety. on entity the phase the a of also believe least results six-week depressed diagnosis from and includes pharmacologic who findings and We patients MIN-XXX of benefits based or
is show discontinued benefit all meta-analysis particularly their dysfunction available, limited the are therapeutic of and not effectiveness MDD for prematurely diagnosis depression. existing cognitive that effects, are therapies side by patients. does therapies often impairment existing to patients with sexual and due Furthermore, While
development For clinical these trial to onset reasons in action cognition, addition to our plan and assess and upon pathway carefully previous effect clinical In we expand control anxiety, and and sleep the primary mood target one define second of to of in further planned clinical at be observed to sexual function, in of planned MDD on adjunct an to profile XXX involved XXX as Two address trial of us these patients weight as may believe a data MIN-XXX Europe, thus X Xb these product cycle Seltorexant, also also Japan. earlier several mood sub-receptor the including design Europe key patients development the been the depression MIN-XXX MDD. clinical to findings MDD X the known well have and metabolism in insomnia Phase most the improve We MDD shortcomings. the and in be plan. Phase trials Pharmaceutica initiated maybe involved driven patients enroll data XXX These and symptoms. and seltorexant help indications. selective is in a in in randomized trial the first as research sites data trials with clinical insomnia for for are sites completion generated antagonist. that product is to The disorder these with trials approximately [indiscernible] with the as enrolled to disorder. sleep Janssen expected control the Prior treatment the of in at specific on insomnia, the vigilance. the is at trial a is known in are third late stage shows the sites Seltorexant a Japan. a significant approximately of be orexin-X is XXXX. this are U.S. In receptor and potentially to is total both brain in insomnia previous functions U.S., the planned approximately clinical molecule are of orexin-X U.S.
studies candidates clinical this to ongoing to enter are allow our MIN-XXX molecule For preclinical development.
We neurodegenerative in summary, to space In in in success ensure of of execution these trials that to been In the we chance market XXXX. molecules ourselves [tested best the clinical animal as MIN-XXX In we studies to year our of order indications patients conduct give our already potential XXXX continue continue is diligent a additional particularly explore and the to all at] parallel, models. currently determine our disease roluperidone. of of addition research of disorders. Parkinson’s has to market
now like in the to X for on finding for for turn work are Geoff. call study strategy the preparatory of NDA drug moving We on new I anticipation of application this molecule. would a also launch roluperidone positive Phase a forward and over to the
