HistoIndex’s Stain-free AI-based Digital Pathology Incorporated as Secondary and Exploratory Efficacy Endpoints in Sagimet’s NASH FASCINATE-2 Phase 2b Clinical Trial
Singapore, 18 August 2021 – HistoIndex, a global leading artificial intelligence (AI) digital pathology provider, has announced an agreement with clinical-stage biotechnology company Sagimet Biosciences. HistoIndex’s integrated suite of stain-free imaging with AI-based fully quantitative and zonal analysis of fibrosis will play a role in Sagimet’s Nonalcoholic Steatohepatitis (NASH) Phase 2b multi-center, double-blind, randomized placebo-controlled trial (FASCINATE-2) as both secondary and exploratory efficacy endpoints.
Sagimet’s wholly-owned TVB-2640, an oral fatty acid synthase (FASN) inhibitor, recently demonstrated statistically significant improvements across steatosis, inflammation/lipotoxicity, fibrosis and metabolic biomarkers important in NASH in the company's FASCINATE-1 Phase 2 clinical trial of NASH patients in the United States1 and China2. These encouraging data supported TVB-2640 in receiving a Fast Track designation3 by the FDA.
Assessment of Secondary and Exploratory Efficacy Endpoints
The integrated AI stain-free platform, which comprises the Genesis®200 Second Harmonic Generation (SHG) imaging system and image analysis algorithms, will assess approximately 330 paired patient biopsies for secondary efficacy endpoints. These include determining the effect of TVB-2640 compared to matching placebo on the change from Baseline to Week 52 in the fully quantitative measurement of collagen/fibrous area and the corresponding qFibrosis value. In addition, the platform will also be used as an exploratory efficacy endpoint to evaluate the concurrence of fibrosis with steatosis by fully quantifying the zonal fibrosis change from Baseline to Week 52.
Says Dr. Eduardo Bruno Martins, M.D., D.Phil., Sagimet’s Chief Medical Officer, “As NASH is a complex disease, having stain-free histological imaging coupled with artificial intelligence will aid in the granular characterization and quantification of our histological results in an objective and consistent manner. We are hopeful the results will lead to a greater understanding of the efficacy of TVB-2640 in NASH.”
Says Dr. Gideon Ho, CEO of HistoIndex, “We have seen promising data from our past and current applications in NASH Phase 2/3 clinical trials that elucidated the magnitude of the therapeutic efficacy. We are more motivated than ever to incorporate our stain-free AI-based technology in FASCINATE-2 as both secondary and exploratory efficacy endpoints so as to enable biopharma companies like Sagimet to bring an approved drug expeditiously to NASH patients worldwide.”
NASH, the most aggressive form of nonalcoholic fatty liver disease (NAFLD), is a major worldwide public health concern especially in the U.S.4, India5 and China6. In the U.S., prevalent NAFLD cases are expected to reach 100 million by 2030, while prevalent NASH cases will increase by 63% from 16 million (2015) to 27 million cases by 20307. There are currently no FDA-approved treatment options to treat this significant unmet medical need. Without effective treatment, NASH – a leading cause of liver transplantation in many countries – can progress to end-stage liver disease such as cirrhosis and hepatocellular carcinoma. Due to the high prevalence and increased health risks, NASH represents significant economic and healthcare burdens.
Founded in Singapore, HistoIndex is a leading MedTech/Healthcare company that specializes in its proprietary integrated stain-free AI digital pathology platform. Enabled by Second Harmonic Generation (SHG) and Two-Photon Excitation (TPE) along with automated imaging analysis algorithms, the integrated platform accurately quantifies histological features and fine measurements that are critical for the evaluation of therapeutic efficacy in clinical trials. The stain-free AI platform is currently involved in multiple FDA clinical trials for Nonalcoholic Steatohepatitis (NASH). In addition, it has benefitted more than 150 research and academic institutes, CROs and biopharma companies around the world in drug discovery and development efforts for fibrotic diseases and cancers.