ASP3652 / Autobahn Therap - LARVOL DELTA

What is in the pipeline for new treatments for bladder pain syndrome/ interstitial cystitis? (PubMed, Curr Opin Urol) - "Validation of these studies is arduous due to the broad spectre of BPS/IC phenotypes, small number of patients enrolled, distinct outcome measures and short-term follow-up. It is also important to highlight that some authors combined therapies, and others split central and peripheric phenotypes before treatment. Therefore, soon, phenotyping and combining therapies with a step-by-step approach will be needed in BPS/IC treatment."

Journal • Interstitial Cystitis • Musculoskeletal Pain • Pain

An adaptive randomized clinical trial in interstitial cystitis/bladder pain syndrome evaluating efficacy of ASP3652 and the relationship between disease characteristics and Hunner's lesions. (PubMed, World J Urol) - P2 | "ASP3652 was safe and well tolerated, but did not show efficacy in IC/BPS. The observed differences between HL+ and HL- suggest that IC/BPS diagnosis and treatment may be approached differently in these two phenotypes."

Clinical • Journal • Interstitial Cystitis • Pain

Investigation of Safety and Tolerability of ASP3652 Based on Clinical Studies of Cerebrospinal Fluid Transfer After Multiple Doses and Exposure After Single Doses at High Dose Levels. (PubMed, Adv Ther) - P1 | "ASP3652 showed low CNS penetration at the anticipated therapeutic dose and was well tolerable without any CNS-related AEs at supratherapeutic doses, supporting that the drug can be safely tested at the anticipated therapeutic dose."

Clinical • Journal

The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASP3652 in First-in-Human and Ascending Multiple Oral Dose Studies in Healthy Subjects. (PubMed, Adv Ther) - "Single and multiple doses of ASP3652 were safe and well tolerated and increased endogenous cannabinoid plasma levels."

Clinical • Journal • P1 data • PK/PD data • Gynecology • Pain

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASP3652, a Reversible Fatty Acid Amide Hydrolase Inhibitor, in Healthy, Nonelderly, Japanese Men and Elderly, Japanese Men and Women: A Randomized, Double-blind, Placebo-controlled, Single and Multiple Oral Dose, Phase I Study. (PubMed, Clin Ther) - "Single and multiple doses of ASP3652 were well tolerated and increased endogenous cannabinoids."

Clinical • Journal • P1 data • PK/PD data