Drug intelligence / Profile preview

ATI-1801

Development stage
Unknown
Lead developer
Appili Therapeutics
Modality
Small Molecules, Transdermal Patches → Device-based Delivery → Drug Delivery Systems, Hydrogel Systems → Drug Delivery Systems
Administration
Topical
01

Overview

ATI-1801 is a novel topical formulation of paromomycin (15% w/w) developed for the treatment of cutaneous leishmaniasis, a disfiguring parasitic skin infection. The drug is designed to be applied topically, offering an alternative to invasive treatments that often require hospitalization. ATI-1801 has demonstrated safety and efficacy in multiple Phase 2 and Phase 3 clinical studies, including large trials in Tunisia and Panama where it showed significant improvement in clinical cure rates compared to placebo or vehicle. The product was originally developed by the U.S. Army Medical Materiel Development Activity (USAMMDA) and later licensed by Appili Therapeutics, which is advancing its regulatory submission with the FDA. ATI-1801 acts as an antiparasitic agent through binding to 16S ribosomal RNA, thereby inhibiting protein synthesis in Leishmania parasites[1][2][3][5][6].

02

Targets

30S A-site (Bacterial ribosomal 30S A-site)

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