Gossamer Bio Announces Publication of TORREY Phase 2 Results in the Lancet Respiratory Medicine
03 Maggio 2024 - 2:02PM
Business Wire
Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage
biopharmaceutical company focused on the development and
commercialization of seralutinib for the treatment of pulmonary
arterial hypertension (PAH) and pulmonary hypertension associated
with interstitial lung disease (PH-ILD), today announced the
publication of its TORREY Phase 2 study manuscript in the Lancet
Respiratory Medicine journal. The paper, titled "Seralutinib in
Adults with Pulmonary Arterial Hypertension (TORREY): A Randomized,
Double-blind, Placebo-controlled Phase 2 Trial," details the
study's significant findings in advancing the treatment of PAH.
TORREY was a Phase 2, randomized, multicenter, multinational,
double-blind, placebo-controlled study, evaluating the efficacy and
safety of Gossamer’s novel therapy, seralutinib, in patients with
PAH, a progressive condition that can lead to right heart failure
and significantly reduces quality of life. 86 patients were
randomized to receive either seralutinib or placebo by dry powder
inhaler twice daily for 24 weeks. The results demonstrated a
statistically significant improvement for seralutinib compared to
placebo in the primary endpoint, reduction of pulmonary vascular
resistance (PVR), and other important measures of disease,
including measures of right heart structure and function.
Following the successful completion of TORREY, seralutinib was
progressed into the ongoing global, registrational Phase 3 PROSERA
Study for the treatment of PAH in WHO Functional Class II and III
PAH patients (PROSERA). Details about PROSERA can be found here:
https://clinicaltrials.gov/ct2/show/NCT05934526
"The publication of the TORREY results in Lancet Respiratory
Medicine represents a significant milestone in our ongoing
commitment to addressing unmet medical needs for patients with
pulmonary hypertension,” said Faheem Hasnain, CEO, Co-founder, and
Chairman of Gossamer Bio. “The results detailed in the publication
help to form the basis of our excitement for the potential of
seralutinib to improve the lives of patients living with this
progressive disease."
The manuscript can be accessed at
https://doi.org/10.1016/S2213-2600(24)00072-9 and will be featured
in an upcoming print version of the journal.
About Gossamer Bio
Gossamer Bio is a clinical-stage biopharmaceutical company
focused on the development and commercialization of seralutinib for
the treatment of pulmonary hypertension. Its goal is to be an
industry leader in, and to enhance the lives of patients living
with, pulmonary hypertension.
Forward-Looking Statements
Gossamer cautions you that statements contained in this press
release regarding matters that are not historical facts are
forward-looking statements. These statements are based on the
Company’s current beliefs and expectations. Such forward-looking
statements include, but are not limited to, statements regarding:
the potential benefits of seralutinib for PAH patients. The
inclusion of forward-looking statements should not be regarded as a
representation by Gossamer that any of its plans will be achieved.
Actual results may differ from those set forth in this press
release due to the risks and uncertainties inherent in Gossamer’s
business, including, without limitation: potential delays in the
commencement, enrollment and completion of clinical trials;
disruption to our operations from clinical trial delays and
clinical site staff shortages; the Company’s dependence on third
parties in connection with product manufacturing, research and
preclinical and clinical testing; the results of preclinical
studies and early clinical trials are not necessarily predictive of
future results; the success of Gossamer’s clinical trials and
preclinical studies for seralutinib; interim results do not
necessarily predict final results and one or more of the outcomes
may materially change as the trial continues and more patient data
become available and following more comprehensive audit and
verification procedures; regulatory developments in the United
States and foreign countries; unexpected adverse side effects or
inadequate efficacy of seralutinib that may limit its development,
regulatory approval and/or commercialization, or may result in
recalls or product liability claims; Gossamer’s ability to obtain
and maintain intellectual property protection for seralutinib;
Gossamer’s ability to comply with its obligations in collaboration
agreements with third parties or the agreements under which it
licenses intellectual property rights from third parties; Gossamer
may use its capital resources sooner than it expects; and other
risks described in the Company’s prior press releases and the
Company’s filings with the Securities and Exchange Commission
(SEC), including under the heading “Risk Factors” in the Company’s
annual report on Form 10-K and any subsequent filings with the SEC.
You are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date hereof,
and Gossamer undertakes no obligation to update such statements to
reflect events that occur or circumstances that exist after the
date hereof. All forward-looking statements are qualified in their
entirety by this cautionary statement, which is made under the safe
harbor provisions of the Private Securities Litigation Reform Act
of 1995.
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version on businesswire.com: https://www.businesswire.com/news/home/20240503252709/en/
For Investors and Media: Bryan Giraudo, Chief Operating
Officer and Chief Financial Officer Gossamer Bio Investor Relations
ir@gossamerbio.com
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