Foresee Pharmaceuticals to Present Phase 1/2 Fanconi Anemia Clinical Study Design for its ALDH2 activator FP-045 at the Fanconi Anemia Research Fund 2023 Scientific Symposium

Taipei - Foresee Pharmaceuticals (TPEx: 6576), ('Foresee') announced today that the company will present the clinical design of the FP-045 Phase 1/2 clinical Fanconi anemia clinical study (FuschiA study) currently being initiated, at the Fanconi Anemia Research Fund (FARF) 2023 Scientific Symposium taking place in Vancouver, BC, Canada from September 28-October 1, 2023.

The oral presentation entitled: 'A Clinical Trial Evaluating the Safety & Biological Activity of FP-045, an ALDH2 Activator, in Fanconi Anemia Patients' details the clinical design of the FuschiA Phase 1/2 study that will be conducted in collaboration with clinical experts in the area of Fanconi anemia (FA) from Stanford University, Memorial Sloan Kettering Cancer Center and the University of Minnesota.

Dr. Yisheng Lee, Foresee's Chief Medical Officer presenting the study, stated: 'The FuschiA study is a first-in-patient clinical trial to test the safety and tolerability of FP-045 and to obtain data on preliminary biological activity in FA patients. We are very hopeful in the therapeutic promise of ALDH2 activation for FA patients and are confident the information from this study will help guide future registrational efforts for FP-045 in this highly unmet patient population.'

'We are strong supporters of FARF's mission and are working closely with all stakeholders and patients in the FA community, as we are committed to bringing forward FP-045, a novel oral therapy which we are hopeful one day may become a valuable part of the FA patient treatment standard of care.', stated Dr. Ben Chien, Foresee's Chairman and CEO.

Details of the oral presentation are as follows

Title: A Clinical Trial Evaluating the Safety & Biological Activity of FP-045, an ALDH2 Activator, in Fanconi Anemia Patients

Date: Saturday, September 30, 2023

Time: 11:10 - 11:25 PST

Location: Sheraton Vancouver in Grand Ballroom AB

The presentation slides will become available on the Foresee website after the presentation.

About FP-045 in Fanconi anemia

FP-045 is a first-in-class, potent oral aldehyde dehydrogenase 2 (ALDH2) activator. A dominant-negative allele of ALDH2 in Fanconi anemia (FA) patients is associated with accelerated progression of bone marrow failure, suggesting ALDH2 activation might be a potential therapeutic approach in FA. Laboratory studies demonstrate that FP-045 decreases aldehyde-induced toxicity in lymphoblastoid cell lines from FA patients. Preclinical animal experiments also demonstrated that sustained activation of ALDH2 can prevent Hematopoietic stem cell (HSC) loss in FA, resulting in improved HSC numbers and functions. To allow for clinical testing in FA patients, single ascending dose (SAD), multiple ascending doses (MAD) 7 days studies, and a 28 days dosing study of FP-045 have been conducted in healthy human subjects that showed safety and tolerability of FP-045 following oral administration. Dose-proportionality and time-stability of the pharmacokinetics of FP-045 in humans were also established. Based on these favorable results from healthy subjects and further discussions with regulators, Foresee is initiating the FuschiA study, a first-in-patient Phase 1/2 clinical trial to test the safety and tolerability of FP-045 and to obtain data on preliminary biological activity in FA patients.

About ALDH2

ALDH2 (Aldehyde Dehydrogenase 2) is a mitochondrial matrix enzyme and key regulator of mitochondrial quality control systems/health and regulator of reactive aldehydes/carbonyls, oxidative stress, inflammation, and fibrosis. Activation of ALDH2 is a compelling therapeutic strategy for improving mitochondrial quality and regulatory mechanisms for treating the treatment of rare/orphan diseases and severe diseases of aging. The key role of ALDH2 in disease is supported by strong genetic/GWAS evidence related to a dominant-negative ALDH22 polymorphism.

About Foresee Pharmaceuticals Co., Ltd.

Foresee is a Taiwan and US-based biopharmaceutical company listed on the Taipei Exchange (TPEx: 6576). Foresee's R&D efforts are focused in two key areas, namely its unique Stabilized Injectable Formulation (SIF) long-acting injectable technology with derived drug products targeting specialty markets and secondly, its transformative preclinical and clinical first-in-class NCE programs targeting rare and severe disease areas with high unmet needs. Foresee's product portfolio includes late and early-stage programs. CAMCEVI 42 mg, for the treatment of advanced prostate cancer, is now approved in the U.S., Canada, EU and Taiwan and launched in the U.S. in April 2022. Additionally, U.S. and EU regulatory submissions are under preparation for CAMCEVI 21 mg. The second indication of CAMCEVI 42 mg - central precocious puberty (CPP), the Casppian phase 3 clinical study, has been initiated. FP-025 - a highly selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases, a Phase 2 proof-of-concept study in allergic asthmatic patients. The study has been completed with positive outcomes, with future development in rare immune-fibrotic diseases. FP-045 - a highly selective oral small molecule allosteric activator of ALDH2, a mitochondrial enzyme, for which the FuschiA Phase 1b/2 Fanconi Anemia study is currently being initiated, and a P2 study in pulmonary hypertension-interstitial lung disease (PH-ILD) patients is in planning.

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