Gossamer Bio Announces Publication of TORREY Phase 2 Results in the Lancet Respiratory Medicine

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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