# Initiation of ARN-75039 API and Drug Product NDA Registration Path and Manufacturing of Phase 3 final Drug Product

> **NIH NIH SB1** · ARISAN THERAPEUTICS, INC. · 2024 · $1,000,000

## Abstract

Summary
Arenaviruses comprise a diverse family. Several species are associated with severe
arenaviral hemorrhagic fever (AVHF) in humans. Human infection with arenaviruses
typically occurs through contact with materials contaminated with the excretions of an
infected rodent although direct human- to-human transmission may occur in clinical settings.
AVHF resulting from infection with the Old World arenavirus Lassa is estimated to cause
over 300,000 annual infections in Western Africa, of which 15-20% of hospitalized patients
die while survivors often suffer permanent sequelae. Given the limited treatment and
prophylactic options, the mortality/morbidity rate, the potential for both zoonotic and
human-to-human transmission, geographical transplantation and bio-weaponization
six arenaviruses have been recognized as Category A pathogens. Currently, we have a
clinical highly potent arenavirus entry inhibitor in Phase 1 clinical trial with comparable activity
for all six Category A arenaviruses. The manufacturing of the compound requires 3 step
synthesis with yields of 60-80% and purity >99.5%. In addition, the compound is amenable to
simple formulation for both tablets and capsules with suitable oral bioavailability and half-life to
support once or twice-a-day dosing. Here we propose initiating steps toward registration of
both drug substance and product by evaluating, validating and locking down manufacturing
processes and in parallel manufacture the first of 3 registration drug product batches to be used
for Phase 3 clinical trial.

## Key facts

- **NIH application ID:** 10829181
- **Project number:** 2SB1AI112097-08A1
- **Recipient organization:** ARISAN THERAPEUTICS, INC.
- **Principal Investigator:** Gregory William Henkel
- **Activity code:** SB1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $1,000,000
- **Award type:** 2
- **Project period:** 2014-02-10 → 2027-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10829181

## Citation

> US National Institutes of Health, RePORTER application 10829181, Initiation of ARN-75039 API and Drug Product NDA Registration Path and Manufacturing of Phase 3 final Drug Product (2SB1AI112097-08A1). Retrieved via AI Analytics 2026-06-01 from https://api.ai-analytics.org/grant/nih/10829181. Licensed CC0.

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