for Thank the Good that to treatment is on drug has our for you and little press on the third been evening, last Generation probability the new and our for our drugs, so shared two the news Jim. them cancer in these saw hope of our days. the XX-Q filing formally to from on this had Prior increases you morning which application. some us. release FDA of concentrate of evening. you, Tuesday, great drug releases two XXXX more Capecitabine, what Thank like understand an press of you called I that This eight we the quarter, gastroparesis. appreciate joining XXXXX, our results a drug on last release success can drug to I each over how do Next the for drugs, press
our slide, Capecitabine summarizes First findings This Generation slide XXXXX. X, for Next and slide please.
on, XXXXX. bottom it The first for Generation now are as Next bullets Capecitabine call for three are the the bullets three or NGC, while I'll from
well identified dose-limiting exposures that NGC that dosage in ongoing successfully well as were tolerated trial, and Processa Phase XB regimens has NGC: X-FU as NGC and side first, exposures regimen the X-FU effects. For had
times formation initiate to was an XX Processa Phase greater be Optimus to the for new to the hours hours potency DPD XX plans FDA. of following reported NGC capecitabine. was Second, in XB to than after Project the administered, lastly, for efficacy/safety after trial also XXXX was XXXX, timeline FDA's increased FDA-approved Initiative the approximately meeting XX found dose with while And
been XA at emptying Phase in X.X statistically gastroparesis the trial after proof-of-concept the XXXXX the showing XXXXX, that a completed in milligrams better results on than placebo rate treatment less p-value patients treatment of has of For XX X.X. was gastric days change with than
Second, XB the change Phase XXXXX by placebo is in expected in of And versus the year. an XXXX. to gastroparesis initiate Processa symptoms the for plans efficacy/safety end trial lastly,
Next slide, please.
Next at billion or over many in Generation be which we $X XXXX. previously market NGC Let's US. in NGC, look opportunity more with the a used can called Capecitabine cancers
and most NGC, drug capecitabine cancer Capecitabine is are worldwide. pro-drug another many and To administered in approved non-responders and used the XX% Approximately their chemotherapy approved are Next XXXX. the presently adverse a in in responders, slide. may while X-FU background intravenously even of dose provide possibly responders a treatment. discontinuation XXXX respond. interruption, X-FU not agents US an cancer of events for of these of a oral or XX% regimen, is is X-FU partial widely the receiving modification require that And with having patients and little capecitabine partial do a of
can Approximately cells. left. discontinuation from see Less to is modification the XX% no right discontinuation. oral left, cause on by XX% GI dose through effects X-FU enzyme treatment. catabolites formed after regimen, on but the XX% to dose you to As X-FU. of associated which XX% is the Anabolites, to cancer or capecitabine, as to the modification typically metabolized or kidney. metabolized to severe mucositis, do administration, right. require can side to then have may anti-tumor X-FU the the the than The a and may healthy properties with And include catabolites, DPD cells anabolites, cells, is the kill to The such of neutropenia, left, XX% normal interruption, also effects anabolites eliminated of approximately side diagram their and distress and require of replicating the
is has irreversible form side the to only metabolized eliminated of cause XXXX the that metabolized of in in irreversible can the being After we to anabolites, DPD, binding the inhibitor X% diagram. doses should but on DPD This not the an X-FU that than also not to the to And activity at If slide. XXXX and no not the new are DPD to anti-cancer results administering through dependent new activity body XXXX the the DPD systemically is in the X-FU probably be catabolites. in diagram, to the low XX%. kidney effects. prevents XXXX, metabolize any formation to is being administering, DPD properties. while left also presence X-FU typical on its its are XXXX present, of XXXX the the dependent right catabolites, to greater Next DPD.
Next slide.
Capecitabine the regimen, Generation in capecitabine is findings hours Let's cycle other our one FDA-approved evaluated, to times are timeline profiles. of while day NGC only and NGC now for example, than XX our approximately at was as that administered combination regimen, regimens a different the there is the dose, hours then new day XXXX the From eight. the but which far. reported example, Next XXXX XX of would days. on to from regimens possible an itself example, different XX and This one; for combinations potency regimens thus formation are trial XX in X-FU repeats and a X-FU the the regimens two example, exposure administered is capecitabine In XXXX DPD capecitabine. after after of result through is XXXX Remember, on our catabolites increased greater look
exposures optimal after dose-limiting as as efficacy/safety side identified X-FU purpose successfully Processa plans and Initiative to multiple well tolerated be and trial before, were between following meeting also well merely tolerated rather trial using effects. regimens dosage XB maximum XB not The have both Optimus X-FU an have initiate balance to regimens FDA. safety; efficacy to exposures that with NGC the a And Project safety, in as and and regimens FDA's to Phase regimen the NGC We select stated and that evaluate than dosing will efficacy an better safety, evaluating this achieve dose. of just Phase
I FDA so I one is is that aim between well. will This not slide is Next behind products, Generation very approach the address approach Next this safety. slide. principles the it. describing balance relatively Since to briefly fits Project efficacy Oncology with determine approach say Initiative Capecitabine the for new, it best important provided Optimus optimal the except which have why is and to the regimen combination dosage of
initial of XXXXX The gastroparesis latest is released news morning slide. findings Next patients. this our in
normal Gastroparesis nausea, much a vomiting, belching, affects for that small movement too pain typical The The food the stomach to are does example, manner. symptoms intestine move slide. down Next in in normal too of heartburn. and is your in bloating, the the muscles condition spontaneous stomach. much not the abdomen,
treatment the warning for At Next dopamine neurological gastroparesis. to have only there a of one drug is present, that approved many side and black slide. even ideation. in XX XHTX of only as gastroparesis weeks. which been agonist, effects and has this use and cardiovascular Its box agonist, receptors Metoclopramide, Other effects is because serious a other can is side receptor limited binds Side DX effects. used side effects to have off-label binding. serious such off-target suicidal drugs
these activity. efficacious One XXXX were but related its its in market XHTX drugs effects, in not which side was because agonist the to of cardiovascular gastroparesis was of off pulled
with may XXXXX GI food XXXXX GI agonists on market. slide. from enhances agonist selective also GI XHTX to potent be XHTX move is Next the both secretion to helping It stomach than a small effective motility receptor more disorders. and the intestine. other motility the
XXXXX have stomach and There two slide. gastric effects of trials on clinical Next evaluating the emptying. motility been
was rate. successfully South study emptying This XXXXX constipations volunteers in effects demonstrated gastric first with and conducted functional healthy The in Korea. study constipation the
study. study US is second The our
for less receiving release this group, emptying the nine announced compared six our showed Phase than Our X.X for patients gastric that patients was significantly with p-value trial XA in trial in patients upon morning the each XXXXX milligrams press a X.X. that only rate to proof-of-concept eight patients at gastroparesis placebo, completing to receiving treatment six different
side serious effects. unexpected side cardiovascular effects In addition, effects no or had we including side
trial year. in proof-of-concept XB before only symptoms in trend the a we in XXXX. we study receive is initiate Remember, We of to are efficacy/safety looking of only patients per this group, guide with the strong in to the XX-week expect order plan to Phase the end nine analysis gastroparesis however, efficacy symptom to six us that for given the a
Next slide.
the meeting best best For selecting hope you running trial the trial we moving safety. data designing not and can closer FDA how of are efficacy our only but successful see trial, and a to also optimal dosage regimen NGC I XXXXX, collecting increase we by and having are before to requirements a to likelihood pivotal pivotal demonstrate
five I And a companies. of the companies different then our same corporate there many are only a many to about we from Next are six slides like but other the not short slide. I If slides. other question want far question received. an common provide you're is, companies? overview you hope biotech are see to provide I than investment a remind will is equity at reasons different than asking we information and play why you, Processa look five The Processa that better biotech investors what also the Processa The that question, the why please next team. for to makes six Processa that last other
for operator ask yours: Operator, the questions? lines open of with value concludes increase you for phone can aligned poll please the are now remarks, This Processa. Q&A. the goals my will I to Our