Translate Bio Announces Upcoming MRT5005 Presentations at the 33rd Annual North American Cystic Fibrosis Conference
October 01 2019 - 7:30AM
Translate Bio (Nasdaq: TBIO), a clinical-stage messenger RNA (mRNA)
therapeutics company developing a new class of potentially
transformative medicines to treat diseases caused by protein or
gene dysfunction, today announced upcoming oral and poster
presentations on MRT5005, an inhaled mRNA therapeutic, at the 33rd
Annual North American Cystic Fibrosis Conference (NACFC) taking
place in Nashville, Tennessee from October 31 to November 2, 2019.
The presentations will describe interim results from the
single-ascending dose portion of an ongoing, first-in-human Phase
1/2 clinical trial of MRT5005 in patients with cystic fibrosis
(CF). The presentations will include safety and tolerability data
from the 12 patients enrolled in the single-ascending dose portion
of the clinical trial. The multiple-ascending dose (MAD) portion of
the trial is ongoing with data expected in 2020.
Details of the oral and poster presentation sessions are as
follows:
Oral Presentation
|
Title: |
Safety and Tolerability of a Single Dose of MRT5005, an Inhaled
CFTR mRNA Therapeutic, in Adult CF Patients |
|
Session: |
New & Emerging Therapies to
Correct the Basic Defect |
|
Presenting Author: |
Jonathan B. Zuckerman, M.D.,
Maine Medical Center |
|
Date and time: |
November 1, 2019, 3:35 – 3:45
p.m. CT |
|
Location: |
Room 207 |
|
Abstract number: |
515 |
|
|
|
Poster Presentation
|
Title: |
Safety and Tolerability of a Single Dose of MRT5005, an Inhaled
CFTR mRNA Therapeutic, in Adult CF Patients |
|
Presenting Author: |
Jonathan B. Zuckerman, M.D.,
Maine Medical Center |
|
Date and time: |
October 31, 2019, 11:15 a.m. –
1:45 p.m. CT |
|
Location: |
Exhibit Hall |
|
Poster number: |
515 |
The abstracts can be accessed through the Wiley Online Library
website.
About the Phase 1/2 Clinical Trial The
randomized, double-blind, placebo-controlled Phase 1/2 clinical
trial of MRT5005 plans to enroll up to 40 adult patients with CF
who have two Class I and/or Class II mutations. The primary
endpoint of the trial is to assess the safety and tolerability of
single and multiple escalating doses of MRT5005 administered by
nebulization. Percent predicted forced expiratory volume in one
second (ppFEV1), which is a well-defined and accepted endpoint
measuring lung function, is also being measured at pre-defined
timepoints throughout the trial. The Phase 1/2 clinical trial of
MRT5005 for the treatment of CF is being conducted in collaboration
with the Cystic Fibrosis Foundation Therapeutics Development
Network.
About Translate BioTranslate Bio is a
clinical-stage mRNA therapeutics company developing a new class of
potentially transformative medicines to treat diseases caused by
protein or gene dysfunction. The Company’s MRT platform is designed
to develop product candidates that deliver mRNA carrying
instructions to produce intracellular, transmembrane and secreted
proteins for therapeutic benefit. Translate Bio is
primarily focused on applying its MRT platform to pulmonary
diseases caused by insufficient protein production or where
production of proteins can modify disease. The Company also
believes its technology is applicable to a broad range of diseases,
including diseases that affect the liver, eye and central nervous
system. Additionally, the MRT platform may be applied to various
classes of treatments, such as therapeutic antibodies or vaccines
in areas such as infectious disease and oncology. Translate Bio’s
lead program is being developed as a treatment for cystic fibrosis
(CF) and is in an ongoing Phase 1/2 clinical trial. For more
information about the Company, please visit www.translate.bio or on
Twitter at @TranslateBio.
Cautionary Note Regarding Forward-Looking
StatementsThis press release contains forward-looking
statements within the meaning of The Private Securities Litigation
Reform Act of 1995. Such forward-looking statements include, but
are not limited to, those regarding: the potential for
MRT5005 to address the underlying cause of CF; Translate Bio’s
plans to enroll patients in the Phase 1/2 clinical trial of
MRT5005; and Translate Bio’s plans to report data from the MAD
portion of the Phase 1/2 clinical trial of MRT5005 in 2020. The
words “anticipate,” “believe,” “continue,” “could,” “estimate,”
“expect,” “intend,” “may,” “plan,” “potential,” “predict,”
“project,” “should,” “target,” “would” and similar expressions are
intended to identify forward-looking statements, although not all
forward-looking statements contain these identifying words. Such
statements are subject to numerous important factors, risks and
uncertainties that may cause actual events or results to differ
materially from current expectations and beliefs, including but not
limited to: Translate Bio’s ability to advance the development of
its platform and programs under the timelines it projects,
demonstrate the requisite safety and efficacy of its product
candidates and replicate in later-stage clinical trials any
positive findings from preclinical studies; the content and timing
of decisions made by the FDA, other regulatory authorities and
investigational review boards at clinical trial sites, including
decisions as it relates to ongoing and planned clinical trials;
Translate Bio’s ability to obtain, maintain and enforce necessary
patent and other intellectual property protection; the availability
of significant cash required to fund operations; competitive
factors; general economic and market conditions and other important
risk factors set forth under the caption “Risk Factors” in
Translate Bio’s Quarterly Report on Form 10-Q for the quarterly
period ended June 30, 2019 filed with the Securities and Exchange
Commission on July 31, 2019 and in any other subsequent filings
made by Translate Bio. Any forward-looking statements contained in
this press release speak only as of the date hereof, and Translate
Bio specifically disclaims any obligation to update any
forward-looking statement, whether as a result of new information,
future events or otherwise.
Contacts for Translate Bio |
|
|
|
Investors |
Media |
Teri Dahlman |
Maura Gavaghan |
tdahlman@translate.bio |
mgavaghan@translate.bio |
857-242-7792 |
857-242-7789 |
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