BUSINESS INSIGHTS, PHARMA TECH
businesswire | April 19, 2023
Simulations Plus, Inc. a leading provider of modeling and simulation software and services for pharmaceutical safety and efficacy, announced that the U.S. FDA has renewed its licenses to the DILIsym® software platform, the flagship quantitative systems toxicology (QST) software for predicting and investigating drug-induced liver injury (DILI). The one-year renewal provides continued access to DILIsym software for authorized FDA employees across all FDA divisions.
Dr. Paul B. Watkins, chair of the Scientific Advisory Board of the DILI-sim Initiative, commented, “The FDA’s renewal of these licenses endorses the value of DILIsym software in both predicting liver safety liabilities and defining the underlying mechanisms, which are critical to evaluating risk. The recent signing of the FDA Modernization Act 2.0 by President Biden, which encourages the FDA to limit animal use in drug development, should be a positive catalyst for greater utilization of DILIsym software in drug development. In my role as Chair of the SAB, I am very excited about the direction of the public-private partnership that is guiding further development of the DILIsym platform that will benefit many key stakeholders.”
Dr. Brett A. Howell, President of the DILIsym Services division at Simulations Plus, added, “Given the effect of rising costs on providing vital healthcare, the use of novel simulation technologies to improve the efficiency of drug development is more critical than ever. An important first step is ensuring that regulatory agencies have the most advanced technology tools to fulfill their essential mission. We are delighted the FDA has opted to renew once again and will continue using DILIsym and other Simulations Plus tools to enable reviews and enhance regulatory science.”
DILIsym software results support crucial drug development decisions by predicting potential DILI risk of new drug candidates. The modeling also identifies the biochemical events that lead to DILI caused by a drug and can thereby predict certain subgroups of patients at increased risk for DILI from that drug. The information from DILIsym modeling serves to help guide go/no-go decisions on major drug development projects, potentially avoiding the disastrous financial effects of failed clinical trials, or better, providing assurances that DILI will not be an insurmountable obstacle to regulatory approval. For the past 13 years, DILIsym Services, a division of Simulations Plus, has coordinated the DILI-sim Initiative, which is a public-private partnership that has guided development of the DILIsym software package. DILIsym is available to the pharmaceutical and chemical industries for direct use to predict and understand liabilities via membership in the DILI-sim Initiative consortium and/or commercial licenses. The DILIsym Services division also routinely uses DILIsym for comprehensive consulting services on safety-related issues.
Companies interested in a free trial version of the DILIsym software can request it here.
About Simulations Plus
Serving clients worldwide for more than 25 years, Simulations Plus is a leading provider in the biosimulation market providing software and consulting services supporting drug discovery, development, research, and regulatory submissions. We offer solutions that bridge artificial intelligence (AI)/machine learning, physiologically based pharmacokinetics, quantitative systems pharmacology/toxicology, and population PK/PD modeling approaches. Our technology is licensed and applied by major pharmaceutical, biotechnology, and regulatory agencies worldwide.
BUSINESS INSIGHTS, PHARMACY MARKET
Businesswire | April 10, 2023
Enanta Pharmaceuticals, Inc. a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for EDP-323, Enanta’s L-protein inhibitor in development for the treatment of respiratory syncytial virus (RSV).
"Receiving Fast Track designation from the FDA underscores EDP-323’s potential as a once-daily, oral therapeutic for the treatment of this deadly virus and reflects the pressing need for a highly potent, direct antiviral to treat RSV, particularly for high-risk populations,” said Scott T. Rottinghaus, M.D., Senior Vice President and Chief Medical Officer of Enanta Pharmaceuticals. “Given that EDP-323 has shown sub-nanomolar potency against several RSV-A and RSV-B strains in vitro and is not expected to have cross-resistance to other classes of inhibitors, we believe it could be used as a monotherapy or in combination with other RSV mechanisms to potentially broaden the addressable RSV patient populations or the treatment window. We believe this designation will be a valuable component of our clinical and regulatory strategy as we progress EDP-323 in development.”
The Fast Track program is designed to accelerate the development and review of products such as EDP-323, which are intended to treat serious diseases and for which there is an unmet medical need. Fast Track designation enables more frequent communication with the FDA and eligibility for FDA programs such as priority review and rolling review, if relevant criteria are met.
EDP-323 is being evaluated in a Phase 1 double-blind, placebo-controlled study designed to assess its safety, tolerability, and pharmacokinetics (PK). Enanta plans to present new preclinical PK data at the European Congress of Clinical Microbiology and Infectious Diseases in April and expects to report topline data from the Phase 1 study this quarter.
EDP-323 is supported by in vitro data demonstrating a significant reduction in RSV replication with picomolar potency in primary human bronchial epithelial cells against RSV A and B, with consistent potency across a range of RSV clinical isolates in various cell types. In a mouse model of RSV infection, EDP-323 treatment was associated with dose-dependent decreases in viral load in the lung, reduced lung immunopathology and decreases in pro-inflammatory cytokines, including IFNγ, TNFα, and IL1β. Additionally, EDP-323 has favorable oral bioavailability with good plasma exposures across preclinical species and pharmacokinetic properties supporting once-daily, oral dosing in humans. These data indicate that EDP-323 is a potent inhibitor of RSV replication and has the potential to be a best-in-class, once daily, oral antiviral treatment for RSV.
About Enanta Pharmaceuticals, Inc.
Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for the treatment of viral infections. Enanta’s research and development programs include clinical candidates for the following disease targets: respiratory syncytial virus (RSV), SARS-CoV-2 and hepatitis B virus. Enanta is also conducting research on a single agent targeting both RSV and human metapneumovirus.
RESEARCH, PHARMA TECH
Biocytogen | March 09, 2023
On March 8, 2023, Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen) announced a non-exclusive license agreement with Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen). The deal was facilitated by Johnson & Johnson Innovation LLC.
Under the agreement, Janssen and its affiliates have been granted a global, non-exclusive license to utilize Biocytogen's RenLite® platform and its underlying intellectual property to research, discover, develop, manufacture and commercialize fully human antibody therapeutics, as well as other biological therapeutics, for unlimited drug targets and indications.
RenLite® is a part of Biocytogen's RenMiceTM family of completely human antibodies. RenLite® mice can produce fully human antibody candidates with high affinity, specificity, variety, and druggability, as well as a common light chain for further assembly of multispecific and bispecific antibodies with minimal mismatch and high success rate. In addition, the multispecific and bispecific antibodies assembled following the discovery of RenLite® feature a conventional antibody structure and good physiochemical characteristics that are beneficial for downstream CMC development.
Biocytogen is a leading biotech company that offers comprehensive solutions to the global biomedical community for developing next-generation antibody drugs. It has created a streamlined platform for efficient antibody drug discovery and validation using advanced gene editing technology and modern animal facilities. This includes animal model creation, therapeutic antibody discovery through their RenMab™ mice, and preclinical validation studies in vivo and in vitro. Biocytogen partners with over 70% of the leading biotech and pharmaceutical companies worldwide to develop innovative medicines for a healthier world. The company is a leading figure in the field of biomedical research, pushing the boundaries of what is possible in this critical area of study.