Positive news abounds for the Aicuris team, and patients living with HSV, with the release of new results from their Phase three clinical trials for Pritelivir and initiation of a new clinical trial studying the use of Pritelivir in healthy patients.
Pritelivir was found to be safe and well tolerated up to 600 mg following single and up to 200 mg following multiple once-daily doses. Considering a therapeutic dose of 100 mg once-daily, Pritelivir demonstrated a favorable safety and tolerability and pharmacokinetic profile in healthy subjects to support further development.
Read the results here: First-in-Human, Single- and Multiple-Ascending-Dose, Food-Effect, and Absolute Bioavailability Trials to Assess the Pharmacokinetics, Safety, and Tolerability of Pritelivir, a Nonnucleoside Helicase-Primase Inhibitor Against Herpes Simplex Virus in Healthy Subjects
In exciting, if long-awaited news for patients globally, AiCuris has also initiated a new clinical study that has commenced testing Pritelivir in healthy, immune competent patients. AiCuris had previously been studying Pritelivir among immunocompromised for several years and are currently in Phase three. It is widely assumed it’ll be approved for immunocompromised soon, potentially in 2024, and the FDA has already granted breakthrough designation streamlining the process for approval.
Clinical Trial for new Herpes Simplex Virus Treatment
With the positive results from the initial safety studies in the immunocompromised – this trial would likely be the start of a move to bring the to the general population. Read more and apply to participate (note the study location in London, England) here: Pritelivir Study In Healthy Individuals. The new clinical trial for Pritelivir in health patients ends in May 2023 (five months of study) so AiCuris is moving quickly on Phase one – likely with recent learnings from the earlier trial.
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