GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH)

Summary

The primary objective for this trial is to determine the effect of GB002 (seralutinib) on improving pulmonary hemodynamics in subjects with World Health Organization (WHO) Group 1 PAH who are Functional Class (FC) II and III. The secondary objective for this trial is to determine the effect of GB002 (seralutinib) on improving exercise capacity in this population.

Timeline

Start

2020-11-12

Primary completion

2022-10-17

Completion

2022-11-01

Outcome

Met primary endpoint

paper INTERPRETATION: Treatment with inhaled seralutinib significantly decreased PVR, meeting the primary endpoint of the study among patients receiving background therapy for PAH. PMID 38705167 ↗

registry analysis (superiority test); Placebo vs GB002 (Seralutinib); p = 0.0310; Mean Difference (Net) -96.1 (95% CI -183.5 to -8.8); ANCOVA NCT04456998 ↗

Publications

• Frantz RP, McLaughlin VV, Sahay S, Escribano Subias P, Zolty RL, Benza RL, Channick RN, Chin KM, Hemnes AR, Howard LS, Sitbon O, Vachiery JL, Zamanian RT, Cravets M, Roscigno RF, Mottola D, Osterhout R, Bruey JM, Elman E, Tompkins CA, Parsley E, Aranda R, Zisman LS, Ghofrani HA; TORREY Study Investigators. Seralutinib in adults with pulmonary arterial hypertension (TORREY): a randomised, double-blind, placebo-controlled phase 2 trial. Lancet Respir Med. 2024 Jul;12(7):523-534. doi: 10.1016/S2213-2600(24)00072-9. Epub 2024 May 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Seralutinib	Peptide	90 mg	Inhaled

Indications