-- First presentation of preclinical data describing the activity, pharmacokinetics and safety profile of ABI-5366, supporting planned clinical entry in 1H 2024 --
“We are excited to present data for the first time highlighting the preclinical characterization of our development candidate ABI-5366, including its potent antiviral activity against both HSV-1 and HSV-2 and remarkable sustained plasma concentrations after both oral and subcutaneous dosing,” said
In both the oral and poster presentation entitled “Pre-clinical characterization of ABI-5366: a highly potent long-acting helicase-primase inhibitor for the treatment of high recurrence genital herpes,” data describe ABI-5366’s low-nanomolar potency in vitro against both HSV-1 and HSV-2 clinical isolates. Supporting ABI-5366's potential as a long-acting therapeutic, data also demonstrate ABI-5366's low plasma clearance rates in multiple preclinical models with an extremely low projected clearance rate in humans. Additionally, in multiple preclinical models, oral dosing or subcutaneous injection of ABI-5366 demonstrated sustained plasma concentrations for greater than one month. The presentations also include non-GLP safety data available to date supporting a favorable safety profile for ABI-5366 with high exposure margins and minimal potential for off-target effects. Assembly Bio plans to initiate a Phase 1a study for ABI-5366 in the first half of 2024.
Subsequent to presentation at the
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The information in this press release contains forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to materially differ. These risks and uncertainties include: Assembly Bio’s ability to maintain financial resources necessary to continue its clinical studies and fund business operations; Assembly Bio’s ability to initiate and complete clinical studies involving its therapeutic product candidates, including studies contemplated by Assembly Bio’s collaboration agreements, in the currently anticipated timeframes; safety and efficacy data from clinical or nonclinical studies may not warrant further development of Assembly Bio’s product candidates; clinical and nonclinical data presented at conferences may not differentiate Assembly Bio’s product candidates from other companies’ candidates; results of nonclinical studies may not be representative of disease behavior in a clinical setting and may not be predictive of the outcomes of clinical studies; and other risks identified from time to time in Assembly Bio’s reports filed with the
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