Selonsertib

Seal Rock eligible to receive payments up to €100 million, including regulatory, clinical, and commercial milestone payments, plus tiered royalties SEATTLE, May 31, 2023 /PRNewswire/ -- Seal Rock Therapeutics, Inc., a clinical stage company developing first-in-class and best-in-class kinase inhibitors, today announced it has entered into an out-licensing agreement with GENFIT (Nasdaq and Euronext: GNFT) for the development of an injectable formulation of SRT-015 for acute liver disease, including Acute-on-Chronic Liver Failure (ACLF). Under the agreement, Seal Rock Therapeutics is eligible for payments up to €100 million, including regulatory, clinical, and commercial milestone payments, plus tiered royalties. SRT-015, a highly optimized, second generation, liver-selective inhibitor of Apoptosis Signal-reducing Kinase 1 (ASK1). It is being developed by Seal Rock Therapeutics, in an oral formulation, as a treatment for severe acute alcoholic hepatitis as well as orphan liver diseases and NASH. "We're excited to announce this licensing deal with GENFIT that will accelerate the development of an injectable formulation of our second-generation ASK1 inhibitor SRT-015 for ACLF, a liver disease with high unmet need," said Neil McDonnell, CEO of Seal Rock Therapeutics. "At Seal Rock, we remain focused on initiating a Phase 2a trial of oral SRT-015 for severe alcoholic hepatitis. We will also continue development of our first-in-class LRRK2/ASK1 dual kinase inhibitors for Parkinson's Disease and ALS." "Considering its liver-centric activity, the potential for multi-organ benefits and the breadth of evidence supporting further development in ACLF, we strongly believe in the potential of SRT-015," said Pascal Prigent, CEO of GENFIT. "We are pleased to have this opportunity to develop a new, injectable formulation of SRT-015 for Acute-on-Chronic Liver Failure (ACLF)." About SRT-015 SRT-015 is a second-generation inhibitor of ASK1 developed internally by Seal Rock Therapeutics. Optimized to overcome the liabilities of first-generation ASK1 inhibitors such as selonsertib, and with a liver-preferential distribution, SRT-015 is positioned as a first-in-class product candidate for NASH and AH. About Seal Rock Therapeutics Seal Rock Therapeutics is a privately held, clinical stage company based in Seattle focused on developing first-in-class and best-in-class treatments for severe diseases with limited or no available therapies. Seal Rock is led by an experienced management team with a track record of successful drug discovery, development and commercialization. The company's clinical-stage lead product candidate, SRT-015, is a highly optimized, first-in-class ASK1 inhibitor. Seal Rock is also developing preclinical-stage brain-penetrant ASK1/LRRK2 dual kinase inhibitors for treatment of neurodegenerative conditions such as Parkinson's disease and ALS. For more information, please visit Media Contact: Julie Rathbun Rathbun Communications [email protected] 206-769-9219 SOURCE Seal Rock Therapeutics

Company's NASH Drug Expected to Enter Clinic in 2024 SAN DIEGO, May 2, 2023 /PRNewswire/ -- Viscient Bio, Inc. ("Viscient") today announced it has identified the world's first drug candidate discovered primarily using 3D bioprinted tissue models of disease formed from human cells. Viscient expects to develop the drug to treat non-alcoholic steatohepatitis (NASH), a growing epidemic disease that is believed to affect more than 10% of the US population. NASH can often lead to hepatocellular carcinoma or liver failure. Due to the devastating effects of NASH on patients and its wide prevalence, analysis have projected future pharma industry revenues for the drug in the tens of billions of dollars per year. Continue Reading Viscient's lead compound is an orally delivered small molecule designed to hit a novel target identified in 3D bioprinted and other 3D tissue models of disease. In preclinical studies, the drug has proven to be well tolerated. In Viscient's models of disease, the compound shows reduction of fibrosis as measured by histological evidence similar to that used for human liver biopsy. Using the same model, fibrosis reduction is also seen for obeticholic acid and resmetirom, while no fibrosis reduction is seen for drugs such as cenicriviroc, selonsertib, and elafibranor. The newly discovered target is predominantly expressed in liver tissue. Failed NASH drugs never would have been put in humans based on what can be clearly seen in these models. Tweet this "It is long past time to displace the model of drug development reliant on proof of activity in animals," said Viscient chief executive officer Keith Murphy. "Viscient's trailblazing work has resulted in 3d cellular human models of disease in which the performance of previously tested compounds has matched clinical results. Failed NASH drugs never would have been put in humans based on what can be clearly seen in these models. Our novel compound shows fibrosis reduction in these models, as do NASH drugs known to work in Phase 3, and we are excited to move this lead program forward." The lead compound's clear reduction of fibrosis in Viscient's NASH models is promising because Viscient's 3D models of NASH have shown extremely high correlation with clinical results in patients. The model demonstrates fibrosis reduction for known clinical compounds tested by pharma companies that have that effect in humans, while revealing lack of fibrosis reduction for compounds that failed in Phase 2 or Phase 3 for NASH. The model is accurate in predicting both successes and failures among clinical compounds tested to date. The gene expression of Viscient's models is also well correlated with that seen in disease samples from patients. Though tested post-hoc, the results are not backfit, as the model was finalized before testing of any clinical compounds was conducted. According to the Biotechnology Innovation Organization's 2021 report, only 7.9% of drugs that enter clinical trials are approved for human use. Viscient Biosciences believes that we can achieve a significantly better clinical translation rate than that using more relevant 3D human tissue models of disease, leading to more successes and lower drug development costs per approved drug. Viscient is leading the world in creation of human tissue models with accurate disease relevance, and demonstrating the application of these models to drug development at every stage. About Viscient Biosciences Viscient Biosciences is an early-stage biotechnology company that is developing novel therapies for NASH and other liver diseases. Its lead compound, built to a novel target discovered in proprietary 3D models of human liver disease, is expected to enter the clinic in 2024. Viscient's 3D models of NASH have shown extremely high correlation with clinical results in patients, demonstrating fibrosis reduction for compounds that have that effect in humans while revealing lack of fibrosis reduction for compounds that failed in Phase 2 or Phase 3 for NASH. The gene expression of Viscient's models is also well correlated with that seen in disease samples from patients. Utilizing these 3D human tissues as dynamic models of healthy and diseased human biology for drug development, the company identifies opportunities both for novel therapeutic development and the in-licensing and repurposing of drugs. SOURCE Viscient Bio, Inc.