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

Study to Evaluate Safety and Efficacy of Mirivadelgat in PH-ILD (Windward) (clinicaltrials.gov) - P2 | N=126 | Recruiting | Sponsor: Foresee Pharmaceuticals Co., Ltd. | Trial completion date: Aug 2028 ➔ Feb 2028 | Trial primary completion date: Jun 2028 ➔ Feb 2028

Trial completion date • Trial primary completion date • Cardiovascular • Hypertension • Interstitial Lung Disease • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Foresee's Oral ALDH2 Activator, Mirivadelgat to Enter Clinical Testing in Parkinson's Disease in the SLEIPNIR Phase 2a Platform Trial (PRNewswire) - "SLEIPNIR is a multi-arm Phase 2a clinical trial platform designed to evaluate investigational disease-modifying therapies in Parkinson's disease, with focus on brain penetration, biological target engagement, and mechanistic biomarker effects. The trial has been funded by Cure Parkinson's....Within the mirivadelgat cohort, 40 eligible participants with Parkinson's disease will be randomized 3:1 to receive either mirivadelgat once daily or matching placebo, in addition to standard dopaminergic treatment. The placebo participants from the mirivadelgat cohort will contribute to a pooled placebo group shared across concurrent SLEIPNIR treatment arms, resulting in an effective comparison of 30 participants receiving mirivadelgat versus 30 participants receiving placebo across the platform."

New P2a trial • Parkinson's Disease

FusuciA: A Dose Escalation Study of FP-045 in Patients With Fanconi Anemia (clinicaltrials.gov) - P1/2 | N=0 | Withdrawn | Sponsor: Foresee Pharmaceuticals Co., Ltd. | N=16 ➔ 0 | Recruiting ➔ Withdrawn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