This page is intended to provide scientific information to scientific research professionals. Gossamer Bio’s drug candidates are investigational medicines and have not been approved by The United States Food and Drug Administration (USFDA), Health Canada, the European Medicines Agency (EMA), nor any other regulatory agency.
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We are a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology. Our goal is to be an industry leader in each of these therapeutic areas and enhance and extend the lives of patients suffering from such diseases. To accomplish this goal, we have assembled a deeply experienced and highly skilled group of industry veterans, scientists, clinicians and key opinion leaders from leading biotechnology and pharmaceutical companies, as well as leading academic centers from around the world. Our collective immunology and translational discovery and development expertise serves as the foundation of our company. We are pursuing product candidates with strong scientific rationale to address indications where there is both a high unmet need and an opportunity to develop best-in-class or first-in-class programs.
Oral DP2 antagonist
Phase 2b ongoing
Condition: Asthma
Phase: Phase 2
Description: A randomized, double-blind, placebo-controlled, dose-ranging, multi-center study to evaluate the efficacy and safety of GB001 when added to standard-of care (SOC) asthma maintenance therapy in adults with moderate to severe asthma and an eosinophilic phenotype with respect to asthma worsening at the end of 24 weeks of treatment.
ATS - August 2020
Oral DP2 antagonist
Phase 2 ongoing
Condition: Chronic Rhinosinusitis Without Nasal Polyps and Chronic Rhinosinusitis With Nasal Polyps
Phase: Phase 2
Description: A Phase 2a, randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of GB001 compared with placebo over 16 weeks of treatment in patients with chronic rhinosinusitis with or without nasal polyposis (NP)
Inhaled PDGF receptor kinase inhibitor
Phase 1b ongoing, Phase 2 planned
Condition: Pulmonary Arterial Hypertension
Phase: Phase 1
Description: This is a Phase 1B, randomized, participant- and investigator-blinded, placebo-controlled, multi-center clinical trial to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and biomarkers of inhaled GB002 in adults with World Health Organization (WHO) Group 1 Pulmonary Arterial Hypertension (PAH).
Oral HIF-1α stabilizer
Phase 1b complete, Phase 2 planned
Condition: Ulcerative Colitis
Phase: Phase 1
Description: This is a Phase 1b, randomized, double-blind-, placebo-controlled, multi-center study to evaluate the safety, tolerability, and PK of GB004 in adult subjects with active ulcerative colitis. Target engagement and effect of GB004 on pharmacodynamic biomarkers will be assessed.
Oral CD11b modulator
Phase 1/2 ongoing
Conditions: Pancreatic Adenocarcinoma, Esophageal Adenocarcinoma, Esophageal Squamous Cell Carcinoma ,Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Triple Negative Breast Cancer, Castration-resistant Prostate Cancer, and Microsatellite Stable Colorectal Cancer
Phase: Phase 1
Description: This first-in-human (FIH ) study is an open-label, multicenter study that consists of a Phase 1 Dose Escalation phase of GB1275 monotherapy or in combination with Anti-PD-1 Antibody or in combination with Standard of Care in Patients with Metastatic Pancreatic Adenocarcinoma followed by a Phase 2 Basket Expansion phase in Patients with Specified Metastatic Solid Tumors
Multiple
Preclinical Programs
Gossamer Bio, Inc. is focused on conducting clinical studies required by regulatory authorities to fully answer important scientific questions about the potential risks and benefits of our investigational products, and to obtain regulatory approval prior to marketing and distribution our products. Gossamer Bio, Inc., on behalf of wholly-owned subsidiaries of the organization, is committed to making investigational products available to seriously ill patients who have exhausted other available treatment options and are not eligible to participate on an active clinical trial testing a Gossamer Bio, Inc. investigational product. The Company will review each request for eligibility to allow compassionate access to a Gossamer Bio, Inc. investigational product that is not approved for any purpose in the country from which the request is intended to be used.
To be eligible for access to a Gossamer Bio, Inc. investigational or unlicensed product, patients must meet the following criteria:
a) suffer from a serious or immediately life-threatening disease or condition
b) have undergone appropriate standard treatments and no longer achieving benefit from treatment and no comparable or satisfactory alternative treatment is available or exists to treat the disease or condition
c) are ineligible for participation in any ongoing clinical study of the investigational product, which includes lack of access due to geographic limitations
d) meet any other pertinent medical criteria for access to the investigational or unlicensed product, as established by the Gossamer Bio, Inc. clinical or medically responsible individual
e) the patient must be under a physician’s care who is properly licensed and fully qualified to administer the investigational product
Any use of a Gossamer Bio, Inc. investigational product outside a clinical study in any country must be in accordance with local laws and regulations governing such programs, including Gossamer Bio, Inc. policies and procedures. In general, where permitted by local regulation, the investigational product supplied via compassionate access may no longer be provided by Gossamer Bio, Inc. when it becomes available via the local healthcare system.
