ALDH2

TAIPEI, Aug. 9, 2024 /PRNewswire/ -- Foresee Pharmaceuticals (TPEx: 6576), ("Foresee") today announced several new developments related to its SIF long-acting injectable (LAI) technologies, namely the disclosure of its four novel and proprietary SIF LAI delivery systems: SIF-ADAGIOTM, SIF-LEGATOTM, SIF-DUOTM, and SIF-MEZZOTM. Continue Reading View PDF Building on the tremendous success of its first SIF-derived product CAMCEVI®, Foresee has been continuously developing and expanding its SIF technology platform as well as its industry dominance and leadership in the area of LAI's, from the technology, intellectual property and product development perspective. In view of the complexity of LAI's, requiring a remarkable depth of know-how, expertise, and experience, very few organizations have developed a LAI technology platform with the level of flexibility and adaptability that can be found in the SIF platform. In fact, Foresee has now developed four distinct SIF LAI delivery systems that will enable even greater flexibility and allow to continue to push the boundaries of innovation in complex LAI products. Foresee will be disclosing more information on these new SIF delivery systems over the upcoming months. Below is a summary: Foresee's commercial product CAMCEVI® was developed using its SIF-ADAGIOTM delivery system, based on biodegradable polymers. Foresee is also applying its SIF-ADAGIOTM system to other products in the portfolio, namely FP-014, its best-in-class ready-to-use, subcutaneous, 3 and 6-month triptorelin LAI. The SIF-LEGATOTM system is a novel combination lipid-based system that has the unique advantage of permitting very high drug loading, making it highly adaptable to various drug substances and product profiles. This SIF LAI delivery system is currently being employed for the development of several early neurology products in our portfolio. SIF-DUOTM is a solution-based system which Foresee is using for the development of some of its early psychiatry LAI programs that benefit from this unique delivery system, while our SIF-MEZZOTM delivery system remains in development and optimization phase. "We are pleased to announce these recent developments in our SIF LAI technologies," said Dr. Ben Chien, Foresee's Chairman and CEO. "While we remain very committed to the advancement of our product portfolio across both SIF and NCE programs, we continue to make significant strides in advancing the technology and intellectual property foundations on which we have built our company. A key part of our mission is to remain a leader in complex LAI products and technologies." "We are very enthusiastic about the promise of these emerging SIF delivery systems. We have proven the value of our technology and expertise through the application of our SIF-ADAGIOTM system to CAMCEVI®, a best-in-class product growing successfully in the market, now we are ready to embark in the second phase of our mission by demonstrating the commercial potential of the new delivery systems," said Dr. Yuhua Li, Foresee's Chief Technology Officer. 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, Taiwan and Israel and launched in the U.S. in April 2022. Additionally, U.S. and EU regulatory submissions are under preparation for CAMCEVI® 21 mg. For 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, has been investigated in 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-020, a follow-on oral MMP-12 inhibitor currently in Phase 1, with development targeted in severe asthma, COPD and IBD. FP-045 is 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 the Phase 2 WINDWARD study in pulmonary hypertension-interstitial lung disease (PH-ILD) patients is in planning with targeted initiation in the fourth quarter of 2024. Building on the compelling biology of ALDH2, and translational data from several Foresee ALDH2 activators, a follow-on candidate from a new series of compounds is being selected for development in metabolic syndrome/healthy weight loss and the broader cardiovascular-renal-metabolic space. SOURCE Foresee Pharmaceuticals Co., Ltd.

ANS-858 is a new selective, reversible, orally bioavailable ALDH2 Inhibitor in pre-clinical development to reduce craving. BEL AIR, Md. and SAN FRANCISCO, May 14, 2024 /PRNewswire/ -- Amygdala Neurosciences (a private company) announced today that the Company has closed a new round of equity financing led by ABMRF, the Alcohol Beverage Medicines Research Foundation to fund the Company's IND-stage activities for ANS-858. ABMRF/The Foundation for Alcohol Research is the largest, independent non-profit foundation in North America devoted solely to funding research on the effects of alcohol on health and behavior ( ). The Foundation was established in 1982 as an independent philanthropic organization dedicated to the development and dissemination of new knowledge about the biological, behavioral and social aspects of alcohol consumption. The Foundation's mission is to 1) achieve a better understanding of the effects of alcohol on the health and behavior of individuals, 2) provide the scientific basis for prevention and treatment of alcohol misuse, 3) fund innovative, high-quality research, 4) support promising new investigators, 5) communicate information with the research community and other interested parties. Bruce Ambler, Chair Board of Trustees ABMRF said "Amygdala Neurosciences has established itself as a leader in the field of alcohol research. Craving is a key component of the alcohol use disorder adaptation, which consists of craving, loss of control, and adverse consequences. Amygdala Neuroscience's lead clinical candidate, ANS-858, targets the first of these aspects of the misuse of alcohol." Use of alcohol and alcohol use disorder (AUD) remains high. It is estimated that in 2020 over half of the adult population (54.9% of those 18 years or older) used alcohol resulting in 27.6 million adult Americans (11%) diagnosed with AUD. The US Centers for Disease Control estimated the annual average deaths attributable to excessive alcohol use to be more than 140,000 and the economic cost of AUD to be $249 billion. Current treatments for AUD include a combination of cognitive behavioral therapy, medication, and other counseling. Highlighting the need for more effective and better tolerated treatments, only 362,000 (1.3%) of patients with Alcohol Use Disorder (AUD) receive treatment with a medication. "We are delighted to receive this investment from ABMRF in recognition of our innovative approach to the treatment of alcohol and other substance use disorders. This investment, combined with the grant to support the Investigational New Drug (IND)-enabling and early stage development of ANS-858 made from the National Institute on Alcohol Abuse and Alcoholism (NIAAA, an Institute of the National Institutes of Health (NIH)) under Award Number U43AA030689, further validates our innovative approach and enables the timely development of ANS-858 as an anti-craving therapy for AUD and other harmful cravings." said Brent Blackburn, PhD, Amygdala co-founder and CEO. About ANS-858 ANS-858, a new chemical entity, works in the brain's 'neural interface between motivation and action' to reduce the dopamine surge responsible for craving. Inhibition of ALDH2 has been shown to reduce craving and drug seeking behavior in preclinical studies against multiple addictive agents and has the potential for use as pharmacotherapy for substance use disorders (SUD), binge-eating, and anxiety associated with these disorders. Preclinical and available clinical data demonstrate the potential of selective, reversible ALDH2 inhibition as a promising target for treatment of AUD. Amygdala Neurosciences is developing ANS-858, a proprietary, potent, selective, and reversible inhibitor of ALDH2, for the safe treatment of AUD. About ABMRF ABMRF/The Foundation for Alcohol Research was established in 1982 as an independent philanthropic organization dedicated to the development and dissemination of new knowledge about the biological, behavioral and social aspects of alcohol consumption. Since that time, it has developed into the largest, independent non-profit foundation in North America devoted solely to funding research on the effects of alcohol on health and behavior, and to the prevention of problems related to alcohol abuse. About Amygdala Neurosciences Inc. Amygdala Neurosciences is developing ANS-858 to curb craving. Its mission is to treat individuals who experience harmful cravings associated with chemicals of addiction and food. The company was formed based on technology discovered and developed by members of the companies' leadership team while at CV Therapeutics and acquired from Gilead Sciences. For further Information visit The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. SOURCE: ABMRF, The Foundation for Alcohol Research, and Amygdala Neurosciences Inc Related Links , View original content to download multimedia: SOURCE Amygdala Neurosciences Inc.

TAIPEI, April 30, 2024 /PRNewswire/ -- Foresee Pharmaceuticals (TPEx: 6576), ("Foresee") today announced that the first subject has been dosed in its Phase 1 clinical trial of FP-020 in Australia. The Phase 1 clinical trial is a randomized, double-blind, placebo-controlled, single-center, single, and multiple ascending oral dose study to evaluate the safety, tolerability, and pharmacokinetics of FP-020 in healthy volunteers. Up to 74 subjects will be enrolled at a site in Australia. "We are pleased to announce the dosing of the first subject in this Phase 1 clinical study, marking a significant milestone in the development of FP-020," said Dr. Ben Chien, Foresee's Chairman and CEO. "The initiation of this Phase 1 trial underscores our commitment to advancing innovative therapies to benefit patients with severe asthma and COPD. Additionally, we are working diligently to build a broad franchise leveraging our multiple MMP-12 inhibitors across several therapeutic areas." "We are very enthusiastic about the promise of FP-020 as a best-in-class MMP-12 inhibitor, a pipeline-in-a-drug opportunity with potential for once-a-day oral dosing," said Dr. Wenjin Yang, Foresee's Chief Scientific Officer. About FP-020 and MMP-12 FP-020 is a highly potent and selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases. FP-020 is the new-generation MMP-12 inhibitor developed by Foresee following aderamastat. It exhibits excellent pharmaceutical properties, with greater potency and similarly high selectivity compared to aderamastat. FP-020 has shown a favorable efficacy profile in multiple animal models of idiopathic pulmonary fibrosis and sarcoidosis. MMP-12 plays a role in asthma pathophysiology and is associated with disease severity. A Phase 2 allergen challenge asthma proof-of-concept study in aderamastat has been successfully completed. The key role of MMP-12 in disease is supported by single-nucleotide polymorphisms/genetic evidence related to inflammatory-fibrotic diseases, including asthma and COPD. MMP-12 is a key immune-fibrotic modulator secreted by macrophages and a key regulator of macrophage, neutrophil, and lung epithelial cell biology and is becoming increasingly recognized as a key marker of inflammatory exacerbations and fibrosis. 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 on 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 being prepared 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 has been completed with positive outcomes, with future development in rare immune-fibrotic diseases. FP-020, a follow-on oral MMP-12 inhibitor currently in Phase 1, with development targeted in severe asthma and COPD. 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 Phase 2 study in pulmonary hypertension-interstitial lung disease (PH-ILD) patients is in planning. SOURCE Foresee Pharmaceuticals Co., Ltd.