Thanks, Greg.
As announced expect internal best-in-class an Further, we we a preclinical each that readout what addition has from recently company's the demonstrating become half the announced data believe the has to for In team. from XXXX pipeline. company been remarks, Viking I X of positive first recent be period my exciting with programs new results months, the mentioned an to the program to company clinical important opening in results.
safety, This study agonist VK of dual or a a dose compound program, peptide the XXXX the status X subcutaneous I'll and X, first VKXXXX to tolerability polypeptide, lead weeks. glucagon-like single I weekly glucose-dependent as the promising of up and the GLP-X review receptor of demonstrated ascending injection of administered is our or when GIP for obesity pharmacokinetics VKXXXX. insulinotropic Phase multiple and A receptor.
addition, of subjects In up with after in the signs from loss demonstrated baseline approximately XX no X% weight study to days plateau.
a at study study, line pharmacokinetics subcutaneously doses study XX end for primary VKXXXX Last known the once fall, safety, secondary placebo-controlled, the trial. and administered in II the efficacy as multicenter BKXXXX, receiving initiated Phase Viking was that double-blind, achieved of VENTURE with announced trial evaluated and its This compared results all patients weekly from tolerability, VKXXXX which we the top loss VENTURE placebo. successfully weight In the randomized, weeks. body first quarter, point all with reductions points positive demonstrating weight end of
the VKXXXX in demonstrated primary not compared cohorts course at Statistically dosing week statistically the to receiving mean as of all be for Weight well observed plateauing. weight the body was loss placebo weight patients could did endpoint, doses, all in We show significant of in statistically this body ranging treatment study. were ranging XX.X% significant baseline weeks as evidence this X throughout On differences starting to significant VKXXXX XX-week from and up reductions that XX.X%. achieved relative placebo reductions were and to through up progressive and beyond of further study. believe treated extended suggests period the through XX maintained weight loss to
primarily the well with over majority of activation the The safe events VENTURE the to XX-week related adverse effects be study of trial moderate as GI and also and showed resulting tolerated GLP-X VKXXXX axis. being expected characterized treatment or to treatment-emergent from mild
To at points We clinical follow-up the development including for dosing Following their future the monthly time pharmacokinetic believe of study. returned dosing in to VKXXXX to PK various study, explore resulting completion of merit less this end, in patients measurements. expect dosing of VENTURE frequent we a data assessments, the respective regimens. sites
preference. a We by option Details a who believe and and provide attractive will both to individual regimen lifestyle get provided trial an on as to afforded tailor should closer patients initiation. dosing trial for flexibility wish be we monthly to their design the weekly offering
were completion to next advance C in to requested VKXXXX. development Type second quarter, steps Based study, we Phase a the In VENTURE and with us on intend help VKXXXX for of FDA development following plan III agency, of the the we meeting the the written granted into obesity. from feedback for
expect schedule year. agency and As quarter with a to step, to the development we plan meeting meeting take plans this II an next place end we this currently to of of fourth Phase review the in
are this patients attractive molecule. patients believe potential and for or regard who the maintain tablet attractive already or to could believe the loss to formulation subcutaneous be tolerability an development formulation, subcutaneous this achieved. same the A with is for advantage key option reduce we unexpected treatment transition the a of developing parallel also utilizes challenges weight In safety have seeking from formulation of may formulation formulation an risk to and are an of injection-based initiate represent oral We to which for they oral those this option of the compound. patients could the an We in clinicians. VKXXXX, tablet therapy both a hesitant
meter mass healthy square. This to minimum study days. formulation initiated adults index a for study double-blind, tolerability evaluate once Last as in a tablet VKXXXX. XX was the year, tablet Viking the primary The XX a randomized, objective study kilograms to safety administered the of VKXXXX of of I body per and Phase evaluate placebo-controlled daily was with
pharmacokinetics as and including measures, evaluation pharmacodynamic of well Secondary and and an various administered body the exploratory objectives changes VKXXXX of other as metrics. in included orally weight
reported titrated shown first safe from With and once-daily be we data XX tolerated respect mild. or all VKXXXX oral Among year, study. quarter were placebo. events were majority subjects up tolerability, following of well as as No moderate VKXXXX the compared dosing reported for safety severity with milligrams. adverse to for with the to up among was XX this in were days doses to initial that with reported meaningful subjects In reported receiving at and gastrointestinal treated this to mild treatment-emergent differences VKXXXX events clinically adverse the
of XX- from this the at addition change to Placebo-adjusted in and was to window reductions over dose-dependent X.X% in XX-milligram body weight study from up in observed. progressive body In body baseline. baseline. no with ranging the of VKXXXX plateau Subjects exploratory demonstrated loss safety X.X% weight, reductions assessment and and dose reached XX-day conducted. tolerability, receiving oral levels weight Weight to was up
of rate up on we FDA observed filed to Based second milligrams promising an order an allow pursued. was doses the excellent the the this progression. quarter, per In escalation in loss in profile XX the at the dose to enrollment U.S.-based facilitate to addition day, study improved with with further tolerability weight signal IND study, along of
IND, Following cohort the ongoing. clearance both have of dose daily currently dosing at daily since we milligrams in daily. cohorts of A XX completed XX-milligram and dosing escalation continued and XXX-milligram is
recently longer of for Phase trial submitted this evaluation Obesity a this obesity. believe generated an study this the this patients study a of presentation year. plan in oral larger, XX-week fall abstract Week. in end, from VKXXXX the to We We describing this support with we To initiate quarter study data II in at fourth
VOYAGE our patients Moving fibrosis. the the VKXXXX results the program, in of in XX-week MASH and for NASH third with we or study announced to quarter, positive second clinical treatment histology NASH, VKXXXX from of
the safety liver reminder, fat tissue to of liver least the double-blind, a VKXXXX assess trial, at the NASH receptor tolerability magnetic with fraction The and the biopsy-confirmed hormone orally with international resonance patients content receptor. isoform proton and as Phase Enrollment VOYAGE agonist of molecule fibrosis. randomized, FX as a density beta was FX patients an fibrosis. VKXXXX as IIb fat for as study placebo-controlled, multicenter as is by available that is well measured X% and included in thyroid well small selective As designed efficacy, of imaging
XX% baseline receiving relative from to achieved VOYAGE reductions primary study median fat statistically data change The compared VKXXXX liver the year endpoint treated significant baseline weeks. with among ranged from last initial patients in week to reported patients VKXXXX placebo. The content with XX study from fat with its XX as successfully in demonstrating the XX% demonstrated after liver from had that
relative patients In to XX% addition, liver XX% at VKXXXX fat. in up a least of experienced reduction receiving
of of on fat with presence Efficacy either diabetes. of in NASH status greater NASH, independent fat held X potential type likelihood benefits assessing was VKXXXX resolution that is Reduction on liver the the liver histology of fibrosis associated endpoints or benefit and fibrosis to the improvement. histologic provide suggesting
results stage of achievement improvement. receiving results by NASH histology treatment. of weeks significant trial's resolution and of histologic experienced and the the that clinically additional fibrosis the changes patients combination rate, demonstrating hepatic announced VKXXXX the study, fibrosis after Last and Viking The month, VOYAGE from statistically secondary successful biopsy showed NASH in endpoints assessed resolution XX endpoint improvements evaluating
of On the NASH from resolution with XX% without demonstrated worsening placebo. for ranging XX% resolution rates to fibrosis, endpoint VKXXXX-treated XX% patients compared
On with in of endpoint of no least the the demonstrating from VKXXXX-treated fibrosis a patients range fibrosis secondary in evaluating demonstrating NASH, patients for X-stage compared XX%, to proportion improvement the proportion XX% improvements worsening of XX% placebo. with at
experiencing XX% proportion endpoint NASH evaluating X-stage patients of for VKXXXX-treated XX%, to and fibrosis, both ranged a secondary both the improvement of patients the at On with compared placebo. resolution proportion the the of measures XX% from achieving in least
diarrhea, treatment minimal encouraging through demonstrated from treatment-related weeks. XX Discontinuations adverse events compared frequency low and VKXXXX and tolerability, receiving The compared differences XX VKXXXX of majority, treatment results of similar weeks placebo. due with events patients VKXXXX-treated reported reported among balanced of or among previously weeks to nausea, vomiting rates and and stool with were to were as safety XX% moderate. mild placebo treatment to an XX VKXXXX as patients tolerability among of demonstrated gastrointestinal Turning the adverse excellent with through also profile arms.
best-in-class data through We potential improvement, demonstrate clearly lipids. in efficacy VKXXXX's and improvement plasma for cardiovascular both NASH these resolution along believe the with on fibrosis benefit
NASH, path this we FDA expect preparing currently VKXXXX meeting in meeting an occur the registration are the end the II discuss of We and year. to quarter for of this in for Phase with fourth to
function X-ALD. move Like is neuromuscular available VKXXXX, orally receptor. hormone is the isoform genetic an that second treatment debilitating agonist rare development. peroxisomal hormone mutations is clinical program, small fourth a VKXXXX disorder acids. of or X-ALD molecule is chain selected that VKXXXX beta the in thyroid long and disabled for now metabolic VKXXXX, disorder I'll by of our our receptor to fatty for clinical a the that X-linked transporter very of caused the thyroid beta rare called is also of adrenoleukodystrophy
contribute of the patients metabolize assets believed result, are these efficiently to unable to to compounds of is progression onset a these accumulation As X-ALD. the and and
study this XX and announce AMN. the the this This evaluated Phase enrolling an pharmacokinetics common for and objectives is or double-blind, once being form The form most adult with the AMN results VKXXXX the plasma includes with patients placebo-controlled, patients is randomized, study chain safety, study which trial We the of VKXXXX of of tolerability expect later The administered male long recently orally to enrollment of study in a adrenomyeloneuropathy acids. very Ib are X-ALD, of assessment is primary fatty also of disorder. a daily in multicenter the in to completed in top levels exploratory study days. year. line changes and evaluate
the treatment amylin newest now receptor for our of the program, will obesity. briefly targeting I summarize
preclinical During dual and an American receptor the Association agonist amylin Diabetes from the internally second program. at data developed quarter, Scientific Viking Sessions calcitonin presented
important intake for and As receptor represent an food an to the therapeutic attractive and plays pipeline an in role we important this metabolic obesity the believe control, it amylin opportunity intervention in expand target company's in area. may
Viking's animals. weight obese of presentation intake in X agonist diet-induced demonstrated highlighted receptor food mice. on rats up resulted reduced rats in hours model, dual dose. the ADA post diet-induced single a Viking At and In results profile Viking's to food from that in treatment metabolic in days intake weight body XX obese following body baseline. to company's weight, calcitonin the compounds healthy mouse in and of amylin The in from agonist a reductions period study resulted effects lean series The treatment for up to hours vehicle-treated loss dose, X% XX% XX with XX compared to amylin
We our believe development this other with to move in body approach an mechanism XXXX. agent amylin to program clinical a conjunction represents in as interesting or single mechanisms. We into both using weight, plan
demonstrated from of new intense successful the highlighted as different the the period the conclusion, a pipeline introduction company, of half activity clinical as approximately Phase of of results XXXX baseline was an weekly targeting as XX VENTURE obesity. In promising first safety of to by following body X VKXXXX XX% II subcutaneous program up by well well announcement weight a reduction tolerability. at The from weeks study dosing in of injection as trials and
III positive and meeting currently formulation of to for that completion activity. with the plan and and end the VKXXXX of tolerability oral initiate We're of safety clinical upon an dialogue. study signs Phase Phase Phase II demonstrated The tablet excellent planning I development of of FDA
We expect program Phase later a trial for this this II initiate to year.
readout no receptor fibrosis a achieved to in of FDA demonstrated XX% and meeting to to And of of an improvement our this the year of study the II of beta that both patients discuss the development hormone achieved Phase in with Phase improvement NASH least agonist, from schedule up We path VKXXXX. XX% XX% VKXXXX-treated with for NASH X-stage fibrosis. worsening later our recent NASH, of thyroid to resolution VOYAGE resolution to up and in at NASH, worsening achieved up VKXXXX, with plan the end IIb no fibrosis,
with this to announce enrollment program, With the form we disease completed the recently our adrenomyeloneuropathy year. study Phase to VKXXXX, this later and Ib in data disease orphan in trial of respect a from patients expect
to single combination the the receptors in internally mechanisms. and promising annual We pipeline, our a Association. developed preclinical new believe compounds data as of Finally, agonist with the during series dual value from potential these other meeting the have of agents Diabetes calcitonin amylin to presented American at second quarter, of Viking add both the and
quarter the providing ended million, balance each for key with maturing sheet strong $XXX to execute support of runway milestones Viking's pipeline, the a Finally, needed to the program. company
much for This Operator? open our call today. for Thanks we'll us, concludes prepared questions. joining comments now for very the and
