GB001 / Teijin, Gossamer Bio - LARVOL DELTA

Safety,Tolerability,and Pharmacokinetics Profiles of GB001 Recombinant Peptide Spray in Healthy Subjects (clinicaltrials.gov) - P1 | N=91 | Active, not recruiting | Sponsor: Zhejiang Echon Biopharm Limited | Trial completion date: Apr 2023 ➔ May 2025 | Trial primary completion date: Nov 2022 ➔ Nov 2024

Trial completion date • Trial primary completion date

Safety,Tolerability,and Pharmacokinetics Profiles of GB001 Recombinant Peptide Spray in Healthy Subjects (clinicaltrials.gov) - P1 | N=90 | Active, not recruiting | Sponsor: Zhejiang Echon Biopharm Limited | Recruiting ➔ Active, not recruiting | Trial completion date: Nov 2022 ➔ Apr 2023

Enrollment closed • Trial completion date

Safety,Tolerability,and Pharmacokinetics Profiles of GB001 Recombinant Peptide Spray in Healthy Subjects (clinicaltrials.gov) - P1 | N=90 | Recruiting | Sponsor: Zhejiang Echon Biopharm Limited | Not yet recruiting ➔ Recruiting

Enrollment open

Safety,Tolerability,and Pharmacokinetics Profiles of GB001 Recombinant Peptide Spray in Healthy Subjects (clinicaltrials.gov) - P1 | N=90 | Not yet recruiting | Sponsor: Zhejiang Echon Biopharm Limited | Trial completion date: Apr 2022 ➔ Nov 2022 | Initiation date: Nov 2021 ➔ Jun 2022 | Trial primary completion date: Apr 2022 ➔ Oct 2022

Trial completion date • Trial initiation date • Trial primary completion date

Results of a phase 2b trial with GB001, a DP2 antagonist, in moderate-to-severe eosinophilic asthma. (PubMed, Chest) - "Although GB001 did not significantly reduce the odds of asthma worsening, reductions favoring GB001 were observed. Treatment effects were consistent regardless of high/low Type 2 phenotype. While the overall safety profile was acceptable, GB001 60 mg was associated with risk of liver injury."

Clinical • Journal • P2b data • Asthma • Hepatology • Immunology • Liver Failure • Pulmonary Disease • Respiratory Diseases

Safety,Tolerability,and Pharmacokinetics Profiles of GB001 Recombinant Peptide Spray in Healthy Subjects (clinicaltrials.gov) - P1; N=90; Not yet recruiting; Sponsor: Zhejiang Echon Biopharm Limited

Clinical • New P1 trial

Small blood stem cells for enhancing early osseointegration formation on dental implants: a human phase I safety study. (PubMed, Stem Cell Res Ther) - P1 | "This phase I study shows that treatment of SB cells for dental implantation is well tolerated with no major adverse effects. The use of SB cells for accelerating the osseointegration in high-risk dental implant patients warrants further phase II studies."

Clinical • Journal • P1 data • Hematological Disorders • Immunology • Transplantation • CCL11 • FGF2 • IL17A

Gossamer Bio Announces Fourth Quarter and Full-Year 2020 Financial Results and Provides Business Update (Businesswire) - "GB001: Oral DP2 Antagonist for Eosinophilic Asthma: Gossamer engaged with the FDA and the EMA about the clinical development path in asthma, and based off those interactions, Gossamer believes that there is a viable clinical development path for GB001, or its backup molecule, in asthma. Gossamer does not currently plan to move forward with GB001, or its backup molecule, in further clinical trials without a partner."

Review • Asthma • Respiratory Diseases

Gossamer Bio Announces Third Quarter 2020 Financial Results and Provides Corporate Update (Businesswire) - "GB001: Oral DP2 Antagonist for Moderate-to-Severe Asthma. Engaging with global regulatory authorities regarding the forward clinical development path of an oral DP2 antagonist in moderate-to-severe asthma to inform potential partnerships or strategic alternatives."

Regulatory • Asthma • Respiratory Diseases

Gossamer Bio Announces Topline Results for Phase 2 Trials of Oral GB001 in Asthma and Chronic Rhinosinusitis (Businesswire) - P2b, N=120; LEDA (NCT03683576); Sponsor: GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc.; "Gossamer...today announced topline results from its Phase 2b LEDA trial in patients with moderate-to-severe eosinophilic asthma...The primary endpoint of the trial was not met, though consistent and meaningful numeric reductions in the odds of asthma worsening as compared to placebo were observed across all GB001 groups: 33% (p=0.1425), 32% (p=0.1482), and 35% (p=0.1086)....Full results from LEDA will be submitted for future presentation at an upcoming scientific meeting."

P2b data • Asthma • Respiratory Diseases

[VIRTUAL] IMPACT OF CHANGES IN THE 2019 GINA TREATMENT CLASSIFICATION: ASSESSMENT IN A REAL-WORLD SETTING (CHEST 2020) - "Overall, two-thirds of patients retained the same GINA Step classification across the 2018 and 2019 classifications, while one-third moved to a different step when applying GINA 2019. Most of the change occurred in GINA Steps 4 and 5; nearly half of patients classified as Step 4 according to 2018 criteria (high-dose ICS/LABA) moved to Step 5 when 2019 criteria were applied. CLINICAL IMPLICATIONS: The 2019 changes in the GINA recommendations allocated a higher proportion of patients to GINA Step 5."

Clinical • Real-World Evidence • Asthma • Respiratory Diseases

GB001 in Adult Subjects With Moderate to Severe Asthma (clinicaltrials.gov) - P2b; N=481; Completed; Sponsor: GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc.; Active, not recruiting ➔ Completed

Clinical • Trial completion • Asthma • Respiratory Diseases

[VIRTUAL] GB001, a selective prostaglandin D2 receptor 2 antagonist, blocks signaling in the peripheral blood of healthy subjects (ERS 2020) - P2a, P2b | "Inhibition of PGD2-induced DP2 receptor activation was robust, rapid, and sustained across all doses tested. These data suggest that DP2 receptor blockade with GB001 may attenuate eosinophilic inflammation in diseases like asthma and chronic rhinosinusitis. Sponsored by GB001, Inc."

Clinical • Asthma • Immunology • Otorhinolaryngology • Respiratory Diseases • CD8 • ITGA4 • ITGAM

[VIRTUAL] GB001 is a potent, insurmountable DP2 antagonist with long receptor residence time and extended pharmacodynamic effects (ERS 2020) - P2a, P2b | "GB001 demonstrated high potency, insurmountability, and slow disassociation from the DP2 receptor. These features endow GB001 with prolonged biologic effects that may be key to effectively treating chronic inflammation. GB001 is being evaluated in moderate-severe asthma and chronic rhinosinusitis (NCT03683576; NCT03956862)."

PK/PD data • Asthma • Immunology • Otorhinolaryngology • Respiratory Diseases

[VIRTUAL] GB001 potently inhibits PGD2 metabolite-induced DP2-mediated cell signaling and eosinophil activation (ERS 2020) - P2a, P2b | "GB001 is a potent antagonist of PGD2 metabolite-induced cAMP signaling and human eosinophil DP2 internalization. GB001 inhibition of PGD2 metabolite-induced migration and signaling may be beneficial in controlling PGD2-mediated inflammation. Sponsored by GB001, Inc."

Asthma • Immunology • Otorhinolaryngology • Respiratory Diseases

GB001 in Adult Subjects With Chronic Rhinosinusitis (clinicaltrials.gov) - P2a; N=97; Completed; Sponsor: GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc.; Active, not recruiting ➔ Completed

Clinical • Trial completion • Nasal Polyps • Otorhinolaryngology

Gossamer Bio Announces Data Presentations at the Virtual European Respiratory Society International Congress 2020 (Businesswire) - "Gossamer Bio...today announced that it will present four posters with data relevant to its GB001 and GB002 programs at the Virtual European Respiratory Society International Congress 2020, which takes place from September 7th through 9th."

Clinical • Preclinical • Asthma • Hypertension • Pulmonary Arterial Hypertension • Respiratory Diseases

[VIRTUAL] GB001 Is a Differentiated Potent Prostaglandin D2 Antagonist with Long Receptor Residence Time and Extended Pharmacodynamic Efficacy (ATS-I 2020) - P2b | "GB001 is a differentiated antagonist as demonstrated by high potency, degree of insurmountability and slow disassociation from the DP2 receptor. This long residence time may allow GB001 to be relatively insensitive to changes in PGD 2 concentration, which may be beneficial in controlling inflammation. In addition, GB001 reduced lung infiltration of eosinophils and inflammatory cells and improved lung function in the HDM model of allergic asthma, providing further insights of the role of GB001 in this phenotype."

Clinical • PK/PD data • Asthma • Immunology • Respiratory Diseases

[VIRTUAL] Pharmacokinetics, Pharmacodynamics, and Safety of GB001 in Healthy Non-Asian, Non-Japanese Asian and Japanese Subjects (ATS-I 2020) - "PK of GB001 were similar among healthy subjects irrespective of race following doses of 20 to 80 mg. Oral dosing of GB001 resulted in rapid, profound and sustained PD. GB001 was safe and well tolerated."

Clinical • PK/PD data • Asthma • Respiratory Diseases

Gossamer Bio Announces Data Presentations at the American Thoracic Society 2020 Virtual Conference (Businesswire) - "Gossamer Bio, Inc....today announced that it will present four posters with data relevant to its GB001 and GB002 programs at the American Thoracic Society 2020 Virtual Conference, which takes place from August 5th through 8th."

Clinical • P1 data • PK/PD data • Asthma • Hypertension • Pulmonary Arterial Hypertension • Respiratory Diseases

"Gearing up for virtual #ATS2020! #GOSS is excited to be presenting 4 posters #GB001 #GB002 #GGG" (@GossamerBio)

A study to evaluate safety, tolerability and pharmacokinetics of ADC3680B in subjects with partly controlled atopic asthma (clinicaltrials.gov) - P2, N=36; Recruiting; New P2 trial

New trial • Asthma • Immunology

Gossamer Bio announces first quarter 2020 financial results and provides corporate update (Businesswire) - "'The trends observed in the clinical endpoints from a 28-day study with a limited number of patients, especially those endpoints that reflect GB004's novel mechanism of action, such as histologic remission and mucosal healing, are very exciting,' said William Sandborn, M.D....Gossamer recently completed a pre-specified interim analysis of LEDA, its Phase 2b clinical study of GB001 in moderate-to-severe eosinophilic asthma. The interim analysis was based on approximately the first two thirds (~320) of patients who either completed or withdrew from the study...Gossamer has commenced initial Phase 3 planning...Topline results from LEDA continue to be expected in the second half of 2020...This patent is not due to expire before 2037."

Media quote • New P3 trial • P2b data • Patent • Asthma • Respiratory Diseases

GB001 Is a Differentiated Potent Prostaglandin D2 Antagonist with Long Receptor Residence Time and Extended Pharmacodynamic Efficacy (ATS 2020) - P2b | "GB001 is a differentiated antagonist as demonstrated by high potency, degree of insurmountability and slow disassociation from the DP2 receptor. This long residence time may allow GB001 to be relatively insensitive to changes in PGD2 concentration, which may be beneficial in controlling inflammation. In addition, GB001 reduced lung infiltration of eosinophils and inflammatory cells and improved lung function in the HDM model of allergic asthma, providing further insights of the role of GB001 in this phenotype."

Clinical • PK/PD data

Pharmacokinetics, Pharmacodynamics, and Safety of GB001 in Healthy Non-Asian, Non-Japanese Asian and Japanese Subjects (ATS 2020) - "PK of GB001 were similar among healthy subjects irrespective of race following doses of 20 to 80 mg. Oral dosing of GB001 resulted in rapid, profound and sustained PD. GB001 was safe and well tolerated."

Clinical • PK/PD data