Professional Documents
Culture Documents
Your Health Our cience Our People Our Purpoe Our Product
NW / Pfizer Initiate Phae 1 tud of Novel Oral Antiviral Therapeutic Agent Againt AR-CoV-2
In-vitro tudie conducted to date how that the clinical candidate PF-07321332 i a potent proteae inhiitor with potent anti-viral activit againt AR-CoV-2
Hide Thi i the firt orall adminitered coronaviru-pecific invetigational proteae inhiitor to e evaluated in clinical tudie, and follow Pfizer’ intravenoul adminitered
invetigational proteae inhiitor, which i currentl eing evaluated in a Phae 1 multi-doe tud in hopitalized clinical trial participant with COVID-19
NW YORK--(UIN WIR)-- Pfizer Inc. (NY: PF) announced toda that it i progreing to multiple acending doe after completing the doing of ingle acending doe
in a Phae 1 tud in health adult to evaluate the afet and tolerailit of an invetigational, novel oral antiviral therapeutic for AR-CoV-2, the viru that caue COVID-19.
Thi Phae 1 trial i eing conducted in the United tate. The oral antiviral clinical candidate PF-07321332, a AR-CoV2-3CL proteae inhiitor , ha demontrated potent in
vitro anti-viral activit againt AR-CoV-2, a well a activit againt other coronavirue, uggeting potential for ue in the treatment of COVID-19 a well a potential ue to
addre future coronaviru threat.
“Tackling the COVID-19 pandemic require oth prevention via vaccine and targeted treatment for thoe who contract the viru. Given the wa that AR-CoV-2 i mutating
and the continued gloal impact of COVID-19, it appear likel that it will e critical to have acce to therapeutic option oth now and eond the pandemic,” aid Mikael
Dolten, MD, PhD., Chief cientific Officer and Preident, Worldwide Reearch, Development and Medical of Pfizer. “We have deigned PF-07321332 a a potential oral
therap that could e precried at the firt ign of infection, without requiring that patient are hopitalized or in critical care. At the ame time, Pfizer’ intravenou antiviral
candidate i a potential novel treatment option for hopitalized patient. Together, the two have the potential to create an end to end treatment paradigm that complement
vaccination in cae where dieae till occur.”
Proteae inhiitor ind to a viral enzme (called a proteae), preventing the viru from replicating in the cell. Proteae inhiitor have een effective at treating other viral
pathogen uch a HIV and hepatiti C viru, oth alone and in comination with other antiviral. Currentl marketed therapeutic that target viral proteae are not generall
aociated with toxicit and a uch, thi cla of molecule ma potentiall provide well-tolerated treatment againt COVID-19.
The Phae 1 trial i a randomized, doule-lind, ponor-open, placeo-controlled, ingle- and multiple-doe ecalation tud in health adult evaluating the afet,
tolerailit and pharmacokinetic of PF-07321332.
Initiation of thi tud i upported preclinical tudie that demontrated the antiviral activit of thi potential firt-in-cla AR-CoV-2 therapeutic deigned pecificall to
inhiit replication of the AR-CoV2 viru. The tructure of PF-07321332, together with the pre-clinical data, will e hared in a COVID-19 eion of the pring American
Chemical ociet meeting on April 6.
Pfizer i alo invetigating an intravenoul adminitered invetigational proteae inhiitor, PF-07304814, which i currentl in a Phae 1 multi-doe trial in hopitalized
clinical trial participant with COVID-19.
At Pfizer, we appl cience and our gloal reource to ring therapie to people that extend and ignificantl improve their live. We trive to et the tandard for qualit,
afet and value in the dicover, development and manufacture of health care product, including innovative medicine and vaccine. ver da, Pfizer colleague work
acro developed and emerging market to advance wellne, prevention, treatment and cure that challenge the mot feared dieae of our time. Conitent with our
reponiilit a one of the world' premier innovative iopharmaceutical companie, we collaorate with health care provider, government and local communitie to
upport and expand acce to reliale, affordale health care around the world. For more than 170 ear, we have worked to make a difference for all who rel on u. We
routinel pot information that ma e important to invetor on our weite at www.Pfizer.com. In addition, to learn more, pleae viit u on www.Pfizer.com and follow u
on Twitter at @Pfizer and @Pfizer New , LinkedIn , YouTue and like u on Faceook at Faceook.com/Pfizer .
DICLOUR NOTIC: The information contained in thi releae i a of March 23, 2021. Pfizer aume no oligation to update forward-looking tatement contained in thi releae
a the reult of new information or future event or development.
Thi releae contain forward-looking information aout Pfizer’ effort to comat COVID-19, Pfizer’ oral antiviral clinical candidate PF-07321332, a AR-CoV2-3CL proteae
inhiitor, and Pfizer’ intravenoul adminitered invetigational proteae inhiitor, PF-07304814, involving utantial rik and uncertaintie that could caue actual reult to differ
materiall from thoe expreed or implied uch tatement. Rik and uncertaintie include, among other thing, the uncertaintie inherent in reearch and development,
including the ailit to meet anticipated clinical endpoint, commencement and/or completion date for clinical trial, regulator umiion date, regulator approval date and/or
launch date, a well a rik aociated with preclinical and clinical data (including the in vitro data), including the poiilit of unfavorale new preclinical, clinical or afet data
and further anale of exiting preclinical, clinical or afet data; the ailit to produce comparale clinical or other reult; the rik that preclinical and clinical trial data are uject
to differing interpretation and aement, including during the peer review/pulication proce, in the cientific communit generall, and regulator authoritie; whether
regulator authoritie will e atified with the deign of and reult from thee and an future preclinical and clinical tudie; whether and when an drug application for an
potential indication for PF-07321332 or PF-07304814 ma e filed in an juridiction; whether and when regulator authoritie in an juridiction ma approve an application
for PF-07321332 or PF-07304814, which will depend on mriad factor, including making a determination a to whether the product’ enefit outweigh it known rik and
determination of the product’ efficac and, if approved, whether it will e commerciall ucceful; deciion regulator authoritie impacting laeling or marketing,
manufacturing procee, afet and/or other matter that could affect the availailit or commercial potential of PF-07321332 or PF-07304814, including development of product or
therapie other companie; uncertaintie regarding the impact of COVID-19 on Pfizer’ uine, operation and financial reult; and competitive development.
A further decription of rik and uncertaintie can e found in Pfizer’ Annual Report on Form 10-K for the fical ear ended Decemer 31, 2020 and in it uequent report on
Form 10-Q, including in the ection thereof captioned “Rik Factor” and “Forward-Looking Information and Factor That Ma Affect Future Reult”, a well a in it uequent
report on Form 8-K, all of which are filed with the U.. ecuritie and xchange Commiion and availale at www.ec.gov and www.pfizer.com.
Media Contact:
Pamela iele
+1 (347) 244-0271
Pamela.iele@Pfizer.com
Invetor Contact:
Chuck Triano
+1 (212) 733-3901
Charle..Triano@Pfizer.com
YOUR HALTH OUR CINC OUR POPL OUR PURPO OUR PRODUCT CARR-KR
INVTOR
Health Living Therapeutic Area Meet the xpert Commitment To Gloal Health Product Liting
NW & MDIA
Dieae Condition Product Pipeline The Journe Poition on Health Policie How Drug are Made
PARTNR
Manage Your Health Clinical Trial Leaderhip Tranparenc Ditriutor
MRCHANDI
R&D Platform Divere Perpective Contriution & Partnerhip Gloal Product Information
HALTHCAR PROFIONAL
Contact
Collaoration UIN TO UIN
Merchandie
Reearch Ite CHANG RGION
ITMAP
CONTACT U
TRM OF U
PRIVACY POLICY
Copright © 2002-2021 Pfizer Inc. All right reerved. Thi information—including product information—i intended onl for reident of the United tate.
The product dicued herein ma have different laeling in different countrie.