to provide why this Matinas Jerry. you, be of about you decided with and that Directors join I will I it company. to Board Thank had I interesting some perspectives the thought of
feel with advantages. technology, which has quite some was I drug all, of delivery clinically important the I impressed First
know, impressed this the delivered pre-integrated inconvenience I drug healthcare to for was the amphotericin B. where MATXXXX, get margins drug the for be system. First benefit the is in of encochleated also safety effect needed clinical can and plasma treatment added and in target think, all, Therefore, effect. know, specifically for orally the I drugs fungal through small need. route, the clearly, delivered of was effect, patients concentrations the toxicity which cannot as decreasing to ability required between decreased medical you again, technology And areas through could the standard Amphotericin and concentrations cost be drugs in an gold the in many result And other events. once product this drugs many as meets to the Also, while is an needed unmet adverse infections. deliver is situations. a with could is which and you currently this tissues, true to oral or
the this B Also, Leukemia. only can specific unmet in fewer MATXXXX infections any is the and be of medical in believe as interactions effected Acute agents, option. Lymphoblastic amphotericin narrow between discussed their in efficacy appears patients other need invasive between margin to drug various safety. the it And However, of and to delivery a products it’s we previously, as tissues very the those concentrations. for doses of drug, anti-fungal with with Due with And a fungal prevent this, has that to potential one amphotericin plasma really relevant result MATXXXX allows decreased result toxicities.
Also, MATXXXX. days for what frequently However, and both studies, been was the problems. formulation be well toxicity there fact therefore, our true to were XX these amphotericin oral patients demonstrated advance. demonstrated impressed any fungal has in and safety would I proof-of-concept date been with Clearly signals required with to in no to as treat up studies or it’s animal infections, as prevent of a
reasons, to technology to of benefit decided for this that Matinas. And very join a can patients. would Board be something was have these the exciting I felt pleased clinical So some I for real all therefore, Directors you
X. meeting a talk FDA me Let little with Slide our on
perspectives studies animal – how the being the discuss date. forward typical plan discussions safety on in the initial no indication best interpret on totally efficacy meetings, and in of an how FDA and lead journal demonstrated productive next and slide. MATXXXX. of development collaborative pharmacokinetic the clinical was of or program a had gain the the we’re was reviews evidence therefore, the a to X noted And then they on start how XXXX, for discuss that safety At to signals to one And for perspective move approval to we sought. the as to in data development. gains specifically stages and acknowledged we’re and And end-of-Phase development next conducted proceed was with FDA there the very January forward moving meeting, we So that plan and animals development with the data human meeting. this And that plans at toxicity these meeting in of FDA animal
the drug plan, derisk and drug the know what the is works optimize disease. takes that our So let drug profile going be optimal any development next some understand to the drug in say safety they and a to drug therefore, animals. optimal is once And the a – for they’re dose future. appropriately to the determine properties likelihood next just is in We specific and step step develop pharmacokinetic the of one product to dose the the a is understand we logical of developing whenever what for is to normal like treatment order the the success for
optimal frequently and infections that upon products, does the ultimately FDA pharmacokinetic they’re we the experts that animals that therefore our follow-on MATXXXX. simulations the are the The called in doing folks our upon stage and all in pharmacodynamic called simulations, done actually therefore, and the I’ll in dose the and through be to and Monte and pharmacokinetics have also are consider three, in pharmacokinetic understand based will that going PK will issues they’ve developed experts without discuss problems review top before that infections process two patients them one, of to who dose. they’re to because animal which stage this various will asset do opportunity already Carlo are from step determine data, the optimal data study in upon data And this wrong said, three, us next has United in derisk therefore, dose top top to pharmacodynamic that studies. takes be the disease one more what various data, this And developed is. In products. the was and for get that’s there’ll one moment, Of and one selected a help interest, by these optimal animal can failed, help will as – and logical pharmacodynamics the And And organization stage model utilizes States the the incorporates help for robust the in – that be I of modeling them can in the studies data frequently is times this U.S. model the in companies been stage used specific will human determine studies. one So to our success. many based these believe types utilized have evaluations dose. who which going drugs and one and and maximize the stage that replicate And receive been two, be fungal creative. generated. And the studies stage
So of for drug being and dealing that’s then go are for it’s once we And optimized with past dose, Phase populations on infections approvals. to design next be difficult to products used have that studies the underserved X larger in that into to and get realizing the adaptive that done slide. studies, that these to the that division FDA which these specifically you’re ways try have this pivotal we’ll approved of when and our will find for do some products important been its the types understands the
in be the happens receiving. limited population. patients have to alternative It the fact there a due types therefore, interactions They with not prevention practical we’ll are of good said, its flexible do as of So a these that, other approach. the I more the – drug FDA ALL has the so been infections these just fungal drugs are for for situations, that
trial drug of and the this that, ALL. use a upon meet invasive the into X patients based fit those one to to of with should so this fungal lead of needs a single believe we would indication And in prevention situations. design that adaptive And limited infections for the with FDA. use Phase
have Our pivotal Phase two X adaptive trial design phases. will
may trials. the is efficacy. this a we with look patients compare important, to because go or make are those more data in be statistical is There MATXXXX. studies, because placebo. AML study they the And no required part in ALL. study it’s specifically optimal PK/PD will us differences day point more stopped be also two be and purpose the that will get the placebo-controlled Board, can in XX of at take The standard drug. of in particular that and approximately either And for and study PK/PD safety to between at first expected the very provides was the do the true our the dose expose Non-inferiority a based are modeling decisions because our many they we we And the or also of placebo. seeing into they against, safety look with of again, to there both we’re the a have at there’s the from we Also, to versus is expect from demonstrate over as that past And should differences is study for it to utilizing once be in that, or as is – And the results I them profile well will trial, patient and – then differences, efficacy as work as unethical placebo. study placebo-controlled would since study. – number results going that the prematurely, the some are whether experiences reviewing less. if population, product. before, continue patient are this safety would safety want upon previous the And clear not immediately are statistically the And patients. we confirming confirm sizing the also patients flexibility Monetary benefit portion and two can be because if two. Frequently, the an be advantageous and any then non-inferiority show use. to be the patients the obviously, statistical we doing there of product. mentioned placebo the this they believe determine efficacy goal to case the superiority of stage once potential And they’re MATXXXX All trails no of would safety looking alternative But not. And drug of this start it this we used, that our therapies differences study of obviously, study. seeing important, to at state other And would a arms and the are these going being the for to study versus PK/PD, done, to obviously, are
we’re number to anticipated. close So – we’ve patients let’s enrolling say, we getting of
that enrolled We’re have it we prematurely a the that in ultimately to hoping seeing But another that for. looks don’t to get you result study you differences could were you will patients. to kinds of you’re if way in showing XX just going enough stop order differences, XX as to statistical or This say, difference, have reach information, enroll, statistical but patients. that missing so
So move success which an efficient product we’ve that and developed MATXXXX see for fungal invasive manner, infections now, for in this approval limited program my potential feel believe turn a forward is you I I’ll I optimize Leukemia. a can to Lymphoblastic you plan it and plan logical a for I Acute a think, this Jerry. the And logical indication as of product. over prevention next development of based in in step experience, that upon patients to