Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as GB002, GB002 (seralutinib)
Seralutinib · 5 trials · 3 indications
PVR was evaluated using right heart catheterization (RHC).
To evaluate the safety and tolerability of GB002
To evaluate the long-term safety and tolerability and efficacy of GB002
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A serious AE (SAE) is one that, in the view of either the investigator or Sponsor, results in any of the following outcomes: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. A TEAE is defined as any AE that has an onset on or after the first dose of study drug and before the end of study/end of treatment (EoS/ET) visit, or any pre-existing condition that has worsened in severity on or after the first dose of study drug and before the EoS/ET visit.
Vital signs evaluated included blood pressure, pulse oximetry, respiratory rate, and temperature.
Physical examination assessments included: physical exam for general appearance; head, ears, eyes, nose and throat; thyroid; lymph nodes; back and neck; heart; chest; lungs; abdomen; skin; and extremities, musculoskeletal and neurological.
12-lead electrocardiograms (ECG) assessments included heart rate, PR interval, QRS duration, QT interval, QTc interval, QTc interval corrected using Bazett's formula (QTcB), QTc interval corrected using Fridericia's formula (QTcF), RR interval.
Pulmonary function tests included forced vital capacity; forced expiratory volume in 1 second (FEV1); forced expiratory flow 25%-75% (FEF25-75); percent predicted forced vital capacity; percent predicted FEV1; and percent predicted FEF25-75.
CL/F is based on nominal (scheduled) dose.
Vz/F is based on nominal (scheduled) dose.
| Arm | Type | Description |
|---|---|---|
| Seralutinib 90 mg | EXPERIMENTAL | Seralutinib inhaled orally twice per day (BID) |
| Placebo | PLACEBO_COMPARATOR | Placebo inhaled orally twice daily (BID) up to 48 weeks |
| GB002 (seralutinib) | EXPERIMENTAL | GB002 (seralutinib) inhaled orally twice per day (BID) for 24 weeks |
| Cohort 1 | EXPERIMENTAL | Patients will be randomized to receive inhaled GB002 or Placebo daily for 14 days |
| Cohort 2 | EXPERIMENTAL | Patients will be randomized to receive inhaled GB002 or Placebo daily for 14 days |
| Open Label Extension | EXPERIMENTAL | Eligible subjects may participate in the Open Label Extension (OLE) study for a period of 24 weeks. |
| Cohort 1A | EXPERIMENTAL | Dose 1 Single Ascending Dose Protocol: within the cohort, 6 participants receive active drug (GB002) and 2 participants receive placebo. |
| Cohort 2A | EXPERIMENTAL | Dose 2 Single Ascending Dose Protocol: within the cohort, 6 participants receive active drug (GB002) and 2 participants receive placebo. |
| Cohort 3A | EXPERIMENTAL | Dose 3 Single Ascending Dose Protocol: within the cohort, 6 participants receive active drug (GB002) and 2 participants receive placebo. |
| Cohort 4A | EXPERIMENTAL | Dose 4 Single Ascending Dose Protocol: within the cohort, 6 participants receive active drug (GB002) and 2 participants receive placebo. |
| Cohort 5A | EXPERIMENTAL | Dose 5 Single Ascending Dose Protocol: within the cohort, 6 participants receive active drug (GB002) and 2 participants receive placebo. |
| Cohort 1B | EXPERIMENTAL | Dose 1 Multiple Ascending Dose Protocol: within the cohort, 6 participants receive active drug (GB002) and 2 participants receive placebo. |
| Cohort 2B | EXPERIMENTAL | Dose 2 Multiple Ascending Dose Protocol: within the cohort, 6 participants receive active drug (GB002) and 2 participants receive placebo. |
| Cohort 3B | EXPERIMENTAL | Dose 3 Multiple Ascending Dose Protocol: within the cohort, 6 participants receive active drug (GB002) and 2 participants receive placebo. |
| Name | Type | Description |
|---|---|---|
| Seralutinib | DRUG | Capsule containing seralutinib |
| Gereic Dry Powder Inhaler | DEVICE | Generic dry powder inhaler for seralutinib delivery |
| Placebo | DRUG | Matching capsule containing placebo |
| Generic Dry Powder Inhaler | DEVICE | Generic dry powder inhaler for seralutinib or placebo delivery |
| GB002 (seralutinib) | DRUG | Capsule containing GB002 (seralutinib) |
| GB002 | DRUG | GB002 low dose or high dose for inhalation |
Inclusion Criteria: 1. Subjects must have completed a qualifying last visit in a prior seralutinib PAH study on investigational product (IP) and in accordance with the protocol. 2. Evidence of an informed consent document, signed and dated by the subject, indicating that the subject has been inform...
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| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Johnson & Johnson | JNJ | 5 | PHASE3 | selexipag, Macitentan |
| Merck & Co., Inc. | MRK | 8 | PHASE3 | Sotatercept, Riociguat, Frespaciguat |
| United Therapeutics Corporation | UTHR | 5 | PHASE3 | Ralinepag, Tyvaso (treprostinil) |
| Insmed Incorporated | INSM | 4 | PHASE3 | Treprostinil Palmitil |
| Liquidia Corporation | LQDA | 4 | PHASE3 | L606, LIQ861 Treprostinil, LIQ861 |
| Tenax Therapeutics, Inc. | TENX | 3 | PHASE3 | Levosimendan (TNX-103) |
| Inhibikase Therapeutics, Inc. | IKT | 2 | PHASE3 | IKT-001 |
| Roivant Sciences Ltd. | ROIV | 3 | PHASE3 | Mosliciguat |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE2 | REGN13335 |
| Tectonic Therapeutic Inc | TECX | 2 | PHASE2 | TX45 |
| Gossamer Bio, Inc. | GOSS | 1 | PHASE3 | Seralutinib |
| Pfizer Inc. | PFE | 1 | PHASE2 | PF-07868489 |
| IRulya Therapeutics Inc. | IRLA | 1 | PHASE2 | LAM-001 |
| GSK plc Sponsored ADR | GSK | 2 | PHASE1 | HS235 |
Seralutinib is an investigational small molecule being developed for the treatment of pulmonary arterial hypertension (PAH), a cardiovascular condition. It is also being studied for pulmonary artery hypertension and related safety issues. It has not been approved for any indication and remains in clinical development.
Seralutinib is an inhibitor of PDGFRB, PDGFRA, CSF1R, and KIT. By inhibiting these receptor tyrosine kinases, it is designed to act on signaling pathways implicated in the disease process of pulmonary arterial hypertension. It is a small molecule therapeutic administered in development for PAH.
Seralutinib is being developed by Gossamer Bio, Inc., which trades under the ticker GOSS. The company is the sponsor of the clinical program evaluating the drug in pulmonary arterial hypertension.
Seralutinib is in Phase 3 clinical development for pulmonary arterial hypertension. It is investigational and has not been approved by the FDA. The program includes completed Phase 1 and Phase 2 studies along with Phase 3 trials.
Seralutinib has been studied across several trials. The Phase 3 PROSERA trial (NCT05934526) is completed, and the Phase 3 open-label extension PROSERA-EXT (NCT06274801) is recruiting. Earlier studies include the Phase 2 trial NCT04456998 and the Phase 1 trial NCT03926793.
Yes, seralutinib is also known as GB002. The earlier Phase 1 and Phase 2 studies of the drug were conducted under the GB002 name, including the Phase 2 trial NCT04456998 titled GB002 in Adult Subjects With Pulmonary Arterial Hypertension.