Joseph K. Belanoff
GRADIENT Corcept. by results new from this thank clear drug in path and The is the GRACE accelerating. Phase year-end. Cushing which and for will us very Charlie, submit syndrome, everyone, studies is for Physician hypercortisolism afternoon. time exciting joining III relacorilant's of This you, we a you, understanding at our Thank and application awareness
physicians will cancer company. in More Cushing of in with high patients and new number that difficult-to-treat trial assumed. are prevalent Korlym patients the previously CATALYST transform trials number these and quarter aware of Success prescribers is patients We in data the much with both in diabetes will our the with IV endeavors third Our another syndrome quarter receiving as Phase now ovarian this generate was than and more will Korlym. with the ALS. hypercortisolism treatment ended
is treating a they refined expertise prescribed, many the developed As more Korlym optimum physicians screening have achieve critical years and in and benefit. patients.
When patients result, infrastructure we are over and role plays many a and helping
improvements and selective glucose Perhaps Korlym the as story well our weight in relacorilant. important, Our Patients and control, in advancement not experienced body business made thriving. the is related signs The used the vaginal by GRACE we and to endometrial other GRADIENT even have cause that and studies of Cushing of its bleeding, hypokalemia, do insufficiency. is recently in events more hypertrophy, Cushing substantial complicated. progress can adverse as of in some modulator, meaningful symptoms be prolongation hypertension, syndrome, was composition QT proprietary and cortisol treat tolerated serious adrenal not well caused medications very Relacorilant syndrome. particular, other
pivotal of weight, score X.XX. those compared cognition, to a Cushing mass, patients GRACE which endpoint, patients taking with Cushing XX placebo. Xx III more of withdrawal relacorilant placebo enter recall, which open-label taking other GRACE, In received weeks. Patients primary the met XX for X.XX relacorilant means was were phase our improvements the half randomized odds compared patients GRACE response life trial waist withdrawal half the for pressure measures. lean in of XXX and phase, those both, Patients quality and patients were meaningful statistically significant of in phase, that met GRACE Phase the hypertension, taking or phase hyperglycemia either and placebo, to with p-value study's relacorilant likely clinically continue endpoint prespecified blood As of hyperglycemia, received pressure control. blood circumference, to syndrome double-blind to relacorilant trial's important basis opportunity exhibited maintain The maintenance In of given muscle open-label ratio, taking its the in the of to which receive you hypertension, ratio the trial's is randomized and of who relacorilant's is for An odds weeks. the primary NDA. clinical improvements X.XX
who cortisol Patients also in it the only received meaningful those weeks with compared and those relacorilant's continue while received who placebo released p-value are substantially the In received and type whose decline, our adrenal often placebo-adjusted compared who adrenal second deciliter, with received millimeters patients with significantly include randomized in glucose significant.
Patients the relacorilant was outcomes or take with in NDA, own, X cortisol III and by required significant results GRADIENT, placebo-controlled experience relacorilant experience of syndrome, that of an therapy. we a the experienced whether Phase weeks.
An In mercury patients in with is from of higher weeks. of the to own. compared tolerated systolic was or trial Notably, an and was weight a who who relacorilant X.X%, those pressure Patients glucose XX their not risk on received to were common received in data compared Cushing's GRADIENT. blood Patients hypertension statistically nausea, who p-value GRACE. compared hypertension placebo meaningful X.X at a in and statistically experienced double-blind, worsening how who most improvements of a of for maintained did to withdrawal patients improvement powerful received placebo metabolism less to to extremities removes randomized, weight who improvements caused the required rescue X in Today, with while significant XX secreting relacorilant Patients pressure the of range the who clinically poor following studies, and These symptoms.
These well XX composition who systolic difference broad but p-value in on at meaningful other and placebo medication, loss hyperglycemia, in weeks stand received pain tumor moderate is start trial's health hemoglobin outcomes our of syndrome placebo ACTH they body but withdrawal while to in to had relacorilant improvement improvements had with their experienced fatigue. those to significant adenoma endpoints. would, pressure XX gradient XX-week composition placebo and it. X.X efficacy of relacorilant back, or received the X.XXXX hypercortisolism statistically fastening open-label adverse received by improvement. XX safety, of improvement received hyperplasia. of of endpoint whose to hypertension, due hyperglycemia, baseline, their patient per The we both received statistically their medical provide do with addition, important to their in relacorilant placebo-adjusted this blood our found further observed in an p-value weight milligrams of of relacorilant body rapid symptoms their the and an in X.XXX. compared XXX not who in clinically are in compared nonsignificant mercury phase evidence of weight as phase, X.XXX rapid a X.XXX improvements of hypertension Cushing The study evidence medications. hypercortisolism significant a placebo hypertension of AXc reduction and with millimeters improvement a primary providing a NDA given death.
GRADIENT's Patients at treated baseline systolic both hyperglycemia consistent study events and in premature rescue secondary blood cortisol of confirming those exhibited Patients were surgery not. improvements a with mild relacorilant and what will worsened placebo during baseline, in in and feature GRACE clinically support who who activity, GRADIENT at body patients kilograms in patients X.X of
As expected, prolongation. no or QT hypertrophy of of related there bleeding, cases insufficiency endometrial and were no of instances its vaginal hypokalemia, cases no adrenal relacorilant-induced
positive can health study, look relacorilant's medications used in work All of patients new for treat efficacy patients taking further physician to now with Cushing supported great arise have and the in continue with patients promise improvement syndrome. events drug adverse rates GRADIENT currently Concurrent advance a hypercortisolism.
The consequences syndrome. awareness of safety patients increase seen understanding to the the we our application, these by in Cushing to with result and global and serious on
who The more prevalence patients than was annual June. in Scientific in found the first X that CATALYST was prevalence addition to hypercortisolism. Our there were large in hypercortisolism from demonstrated assumed enrolled evidence X patients Phase CATALYST, more those produced medications had hypercortisolism. IV common the to results of in Diabetes CATALYST the even than was This with X using They patients with care.
Hypercortisolism presented in this in Of to with far X,XXX patient particularly who, have potent higher advance recognized. Association's X/X field. are are to were American is already Sessions their rate clearly difficult-to-treat diabetes, to for or a of have disease, hypertension. in significantly previously in diagnosed study More study cardiovascular group manage help patients patients were than their diabetes of has implications more found the
portion hemoglobin AXc between of it, The placebo. receive primary In second are study randomized is the hypercortisolism The patients these with Korlym groups. or the in endpoint to is CATALYST either ongoing. reduction
of results study this the year. end the expect of portion We by the of
medication study, plus know, on cancer either with been with we pivotal ovarian basis a as relacorilant. different have resistant prescribed randomized nab-paclitaxel platinum a or cortisol ROSELLA studying our receive women are activity. a to disease relacorilant by types In platinum-resistant nab-paclitaxel, one-to-one you to mediated treatment women As also cancer for often of XXX
years after our nab-paclitaxel, Our design will Phase activity.
ROSELLA's cortisol effects controlled women II the XX% to those relacorilant in alone. II received exhibited intermittently, trial. nab-paclitaxel significant relacorilant successful to the duration took closely the the tracks by of before, expectation live tumors received took effect anti-apoptotic survival improvement arm. of versus patients study the in response relacorilant after the longer a is of received and the Phase nab-paclitaxel day intermittent the and the of relacorilant ovarian blunting XX% the of day who comparator X progression-free in resensitize monotherapy. alive only design start group of than who compared day trial, were who that who the statistically Women also In chemotherapy they group
received relacorilant the those no compared who burden who women experienced Importantly, alone. received to nab-paclitaxel effect side additional nab-paclitaxel plus
by We expect We complete. progression to primary is of to anticipate this ROSELLA study's in survival replicate events the progression-free enough having ROSELLA analyze results.
Enrollment end these endpoint, the year.
appreciate ENGOT collaboration ROSELLA their and have in enthusiasm with We group, are Gynecological stand-alone relacorilant the we as it. States and ROSELLA so conducting can leading the established express Europe, deeply in Gynecologic prompt ovarian or explore Trials, a the women In European clinicians also a us or treatment Oncology to the anticipation from in Oncology after GOG, to other receptor. outcome, Network and for United of of solid and Group, we of a the results successful glucocorticoid conclusion of to stages oncology earlier from bring that the move will who swiftly Positive benefit can division relacorilant cancer support. tumors
exploring this clinicians resurgent block that enzalutamide, escape modulation's switched other treated evaluating we receptor stimulation mechanisms their cortisol to why androgen cancer a with immunotherapy. to tumor potential with reason disease. to be growth.
Leading activity deprivation in with researchers androgen hypothesize of patients chemotherapy, are stimulate and prostate tumor eventually addition its and cortisol antagonist, In modulation to in X experience cortisol resensitize to Deprived major stimulation, of to a Cortisol can androgen activity action combination therapy is widely route. thought tumors prescribed academic
collaborators Our had of randomized Chicago with in currently the initial Phase prostatectomy. are early-stage an these II University placebo-controlled patients plus before relacorilant at of enzalutamide a patients prostate have enrolling cancer trial
Another Because suppresses as enhance immunotherapy. it with checkpoint cortisol such Adding the role of intended therapies effectiveness to to in modulator their immunotherapies may system. of cancer effectiveness. stimulate modulation system, the immune blunt immune cortisol may inhibitors combination a potential is cortisol the
and cancer. Following Ib to tumor combination of evaluating our trial cancer, further modulation stages immunotherapies of the with adrenal understand role we cortisol advanced next Phase steps in types in other in earlier are
of selective modulators X,XXX cortisol library more properties. pharmacodynamic has than research Our distinct with developed a team
tissue potent Some activity are some are types, in more many modulating tissue-specific. across cortisol
Some less models, some oncologic are very potent in so.
Some cross barrier, some the don't. blood-brain
getting is dazucorilant. the One scientists at of created into the have compounds is effective our brain that highly
a We into and clinical of reduced motor dazucorilant in have mouse model and ALS. commonly muscular data on atrophy performance used based improved neuroinflammation advanced studies compelling showing
have sites XXX DAZALS The measure weeks. of milligrams a impact on is II to on is with XX ongoing receive Our XXX basis double-blind randomized functional Phase ALS primary for dazucorilant rating of at been double-blind, revised Canada. Europe, a patients score, trial patients. milligrams United ALS placebo-controlled and scale placebo the clinical in States the XXX either validated on of has endpoint dazucorilant, ALS the or performance randomized
of liver cortisol modulation may an to receive activity implicated expect of a of metabolic the the that for afflicts data patients States. the the in treatment We the by is disorder end has United as serious effective year.
MASH, dysfunction-associated because in been Cortisol initial millions steatohepatitis progression MASH serve both development and disease.
found triglycerides orally dose-finding fat Our insulin XX% in serum a metabolic of Phase patients who measures of and XXX improvements weeks experienced enzymes, lipid XX miricorilant key a in reduction and as received liver Ib twice resistance, study just markers for fibrosis and such that LDL. milligrams and liver week
was patients the arise miricorilant effects Importantly, with very for MASH. of in also which commonly none being well-tolerated GI side treated
MONARCH are In the is receive twice to either XXX for these biopsy-confirmed with biopsy-confirmed randomized weekly results. weeks. MASH secondary encouraging patients Our randomized miricorilant is to placebo-controlled X The IIb X:X enrolling first, this study resolution fibrosis aims endpoint Phase on MONARCH expand XX and double-blind, placebo fat milligrams XXX for in endpoints. or key reduction MASH improvement, of with cohort liver primary cohorts.
XXX XX Corcept. reduction incredibly twice fat.
This cohort, In either milligrams time or Patients primary weeks has the by be is planned followed will for second XX for in a this liver randomized an X:X twice weekly in of the to patients exciting endpoint weeks, miricorilant a The milligrams enrollment with MASH. X weekly is presumed at this receive for cohort miricorilant cohort also placebo XX of XXX whole of weeks.
expect trial Cushing studies in at treatment and we've treatment we DAZALS Positive our assumed. GRACE results understands do. ovarian patients end that transformative study distinct more a to far superior the ALS. be for Cushing GRADIENT study The as from cancer demonstrate will and, Corcept for results The the benefit patients this there patients from strong. is of with clear prevalence study business results from patients serve.
Every it was previously our year, well we than that syndrome. receive syndrome make developed By in commercial with data we our work for syndrome of trial pivotal are Our CATALYST ROSELLA in more these lead the CATALYST Cushing to in importance great the important, employee results as our and company with the
and make cortisol We difference.
Operator, where are driven modulation quickly the support as as other to with Cushing proceed can, syndrome can to now patients effectively a let's disorders and we questions.
