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.
PRNewswire | May 31, 2023
Today, XtalPi Inc., a pioneering pharmaceutical technology company powered by artificial intelligence (AI) and automation, announced an AI drug discovery collaboration of up to $250 million in upfront and milestone payments with Eli Lilly and Company. The collaboration will leverage XtalPi's integrated AI capabilities and robotics platform to de novo design and deliver drug candidates for an undisclosed target.
XtalPi has established itself as an industry leader in combining mutually informative AI "dry lab" algorithms with large-scale "wet lab" robotics to empower pharmaceutical innovation. Building upon existing success, XtalPi will work closely with the Lilly team to harness the power of its proven one-stop AI drug discovery solution to deliver a novel compound, which Lilly will pursue in clinical and commercial development.
XtalPi's ID4Inno™ small-molecule drug discovery platform touts a tightly interwoven trifecta of AI, autonomous labs, and expert domain knowledge that can generate and investigate a target-specific mega chemical space and quickly zero in on the most promising lead series. Each group of synthesized molecules is tested using XtalPi's internal biochemical, cellular, pharmacodynamic, and pharmacokinetic assay capabilities, feeding project-specific R&D data into generative AI models in iterative design-make-test-analyze cycles until a candidate with optimal drug properties emerges.
XtalPi's fleet of hundreds of autonomous robotic workstations can carry out precise and energy-efficient parallel chemical synthesis and assays 24/7. This high-quality real-world data generated with speed and at scale, combined with over 500 AI models and quantum physics algorithms, continuously enhance XtalPi's capability to predict and authenticate novel drug candidates with greatly accelerated timeframes and reduced experimental costs.
XtalPi's AI + robotics platform is supercharging the shift of pharmaceutical R&D from labor-intensive trial-and-error research to a computation and automation-intensive model, empowering scientists to achieve more with less. Serving over 200 pharmaceutical clients and research institutions from around the world, XtalPi is now bringing its proprietary autonomous lab to Cambridge, MA as its drug discovery business continues to grow.
Dr. Jian Ma, CEO of XtalPi, says, "With a closed loop of AI and quantum physics algorithms working in sync with the data factory of large-scale robotics experiments, XtalPi is uniquely equipped to tackle challenging novel targets. We are honored that Lilly has chosen XtalPi's AI + robotics drug R&D platform as a partner in achieving more fruitful pharmaceutical innovation and bringing much-needed treatments to patients worldwide."
XtalPi is a pharmaceutical technology company powered by AI and robotics to improve the speed, scale, novelty, and success rate of drug discovery and development. With operations in both China and the U.S., XtalPi has pioneered a new model for drug R&D that leverages a tightly interwoven trifecta of AI, autonomous labs, and expert domain knowledge. Its integrated AI "dry lab" and large-scale robotics "wet lab" capabilities form an iterative feedback loop that empowers continuous innovation to address the unmet needs of patients worldwide.
Businesswire | May 11, 2023
Simulations Plus, Inc. a leading provider of modeling and simulation software and services for pharmaceutical safety and efficacy, announced the release of a new integrated pulmonary software and services package. This targeted package will support pharmaceutical companies by streamlining their pulmonary drug development processes, enabling them to make better-informed decisions and bring therapies to market faster.
The pulmonary package offered by Simulations Plus is founded on the industry leading GastroPlus® modeling and simulation platform, which can be used to predict localized exposure in the lungs. That localized exposure data is then utilized to inform the ILDsym™ or IPFsym™ platforms for efficacy predictions. As client ventures launch and progress, Simulations Plus scientists will leverage their 40+ years of combined experience in pulmonary exposure and efficacy modeling to train in-house client experts on how to use the software and create models to accurately predict the exposure and efficacy of their pulmonary assets.
“Developing molecules intended to treat interstitial lung disease (ILD) and idiopathic pulmonary fibrosis (IPF) is a daunting challenge; they are serious conditions with no known cures,” explained Dr. Brett A. Howell, President of the DILIsym Services division at Simulations Plus. “We anticipate that the use of our targeted pulmonary package could lead to an acceleration in the development of treatments to slow or even halt progression of these diseases. By integrating the industry-leading platforms for PBPK/PCAT™, quantitative systems pharmacology (QSP), and the expertise of our scientists, along with the training of in-house scientists, we believe we can help our clients develop therapies that will improve and even extend the lives of patients worldwide.”
“Hiring and retaining skilled modelers is difficult, which is why many companies develop talent from within,” noted Vice President of Business Development Josh Fohey. “While we are always pleased to assist with our clients’ drug development programs as an extension of their team, we also want to empower them to engage with their models and data beyond what is typical with consulting relationships. As part of our Pulmonary Package, client teams benefit from a customized learning package using the tools in their program, implemented with support and guidance from our experts. Together, we can better understand lung absorption and efficacy, and find new treatments for respiratory disease.”
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.