mirivadelgat (FP-045) / Foresee Pharma - LARVOL DELTA

FusuciA: A Dose Escalation Study of FP-045 in Patients With Fanconi Anemia (clinicaltrials.gov) - P1/2 | N=0 | Withdrawn | Sponsor: Foresee Pharmaceuticals Co., Ltd. | N=16 ➔ 0 | Recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Anemia • Hematological Disorders

WINDWARD: Study to Evaluate Safety and Efficacy of Mirivadelgat in PH-ILD (clinicaltrials.gov) - P2 | N=126 | Recruiting | Sponsor: Foresee Pharmaceuticals Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Hypertension • Interstitial Lung Disease • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases • CRP • IL6 • TNFA

WINDWARD: Study to Evaluate Safety and Efficacy of Mirivadelgat in PH-ILD (clinicaltrials.gov) - P2 | N=126 | Not yet recruiting | Sponsor: Foresee Pharmaceuticals Co., Ltd. | Initiation date: Dec 2024 ➔ Apr 2025

Trial initiation date • Cardiovascular • Hypertension • Interstitial Lung Disease • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases • CRP • IL6 • TNFA

WINDWARD: Study to Evaluate Safety and Efficacy of Mirivadelgat in PH-ILD (clinicaltrials.gov) - P2 | N=126 | Not yet recruiting | Sponsor: Foresee Pharmaceuticals Co., Ltd.

New P2 trial • Cardiovascular • Hypertension • Interstitial Lung Disease • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases • CRP • IL6 • TNFA

A Multinational Phase 2, Randomized, Double-blinded, Placebo-controlled, Multiple-dose Study to Evaluate the Safety and Efficacy of FP-045, An Aldehyde Dehydrogenase 2 Activator in Patients With Pulmonary Hypertension Associated With Interstitial Lung Disease (ATS 2024) - "The change from baseline to week-12 in the SF-36v2-Health Survey, the Walking Impairment Questionnaire-(WIQ), and patient-reported-outcome measures-(PROM) as CAMPHOR-(or PAH-SYMPACT). Conclusion The WINDWARD Phase-2 Study aims to investigate the potential of FP-045 therapy as a first-in-class small molecule with a novel mechanism of action for patients with PH-ILD."

Clinical • P2 data • Cardiovascular • Hypertension • Interstitial Lung Disease • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases • Transplantation • ALDH2

FusuciA: A Dose Escalation Study of FP-045 in Patients With Fanconi Anemia (clinicaltrials.gov) - P1/2 | N=18 | Recruiting | Sponsor: Foresee Pharmaceuticals Co., Ltd.

Trial completion date • Trial primary completion date • Anemia • Hematological Disorders

A Dose Escalation Study of FP-045 in Patients With Fanconi Anemia (clinicaltrials.gov) - P1/2 | N=18 | Recruiting | Sponsor: Foresee Pharmaceuticals Co., Ltd. | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Jun 2024 ➔ Jun 2025

Trial completion date • Trial primary completion date • Anemia • Hematological Disorders

Open-Label, Randomized, Fasted, Single Oral Dose, Crossover Trial to Assess the Relative Bioavailability of FP-045 and its Metabolite AD-835 After Single Doses of FP-045 2 X 75 mg Capsules (Test Drug) Compared to 150 mg Reconstituted FP-045 Drug Substance Liquid Formulation (Reference Drug) in Healthy Male Participants (ANZCTR) - P1 | N=8 | Completed | Sponsor: Foresee Pharmaceuticals Co., Ltd. | Initiation date: Dec 2000 ➔ Dec 2022

Trial initiation date • Anemia • Hematological Disorders

A Dose Escalation Study of FP-045 in Patients With Fanconi Anemia (clinicaltrials.gov) - P1/2 | N=18 | Recruiting | Sponsor: Foresee Pharmaceuticals Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Anemia • Hematological Disorders

A Dose Escalation Study of FP-045 in Patients With Fanconi Anemia (clinicaltrials.gov) - P1/2 | N=18 | Not yet recruiting | Sponsor: Foresee Pharmaceuticals Co., Ltd. | Trial primary completion date: Aug 2023 ➔ Jun 2024

Trial primary completion date • Anemia • Hematological Disorders

A Dose Escalation Study of FP-045 in Patients With Fanconi Anemia (clinicaltrials.gov) - P1/2 | N=18 | Not yet recruiting | Sponsor: Foresee Pharmaceuticals Co., Ltd. | Trial completion date: Oct 2023 ➔ Oct 2024

Trial completion date • Anemia • Hematological Disorders

A Dose Escalation Study of FP-045 in Patients With Fanconi Anemia (clinicaltrials.gov) - P1/2 | N=18 | Not yet recruiting | Sponsor: Foresee Pharmaceuticals Co., Ltd. | N=56 ➔ 18 | Trial primary completion date: May 2023 ➔ Aug 2023

Enrollment change • Trial primary completion date • Anemia • Hematological Disorders

Phase I/II Study of FP-045 in Patients With Fanconi Anemia (clinicaltrials.gov) - P1/2 | N=56 | Not yet recruiting | Sponsor: Foresee Pharmaceuticals Co., Ltd. | Trial primary completion date: Jan 2023 ➔ May 2023

Trial primary completion date • Anemia • Hematological Disorders

Phase I/II Study of FP-045 in Patients With Fanconi Anemia (clinicaltrials.gov) - P1/2; N=56; Not yet recruiting; Sponsor: Foresee Pharmaceuticals Co., Ltd.

Clinical • New P1/2 trial • Anemia • Hematological Disorders