ATXA will present data from a First-in-Human (FIH) Phase I trial of NTP42:KVA4, a novel formulation of its lead clinical candidate NTP42 at the American Thoracic Society (ATS) International Conference 2023, to be held from May 19-24, 2023 in Washington, DC, USA. NTP42 is an antagonist of the thromboxane receptor (TP) and is being developed for the treatment of Pulmonary Arterial Hypertension (PAH) and other cardiopulmonary conditions.
In a presentation entitled "A Phase I Clinical Trial Assessing the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of NTP42:KVA4, a Novel Thromboxane Receptor Antagonist, in Healthy Subjects", the ATXA team will outline key new data that show that NTP42:KVA4 was generally well-tolerated by healthy adult volunteers with no serious adverse events reported.
ATXA's FIH Phase I trial evaluated the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of NTP42:KVA4 following oral dosing in healthy volunteers. This randomized, double-blind, placebo-controlled trial involved: Part A, a single-ascending dose (SAD) study with 7 cohorts administered single doses of NTP42:KVA4 (0.25–243 mg) or placebo (6 active:2 placebo, fasted). Part B, a food effect study, where one cohort from Part A received NTP42:KVA4 (9 mg) or placebo following a high-fat breakfast. Part C, a multiple-ascending dose (MAD) study where 3 cohorts received NTP42:KVA4 (15–135 mg) or placebo once-daily for seven days. Vital signs, safety labs, ECG, and samples for PK/PD were collected before and after dosing.
Data from this trial demonstrate that orally-administered NTP42:KVA4 was well tolerated, with favorable PK/PD characteristics and evidence of specific TP target engagement. These Phase I trial findings strongly support the continued clinical development of NTP42:KVA4 for PAH and other cardiopulmonary diseases with high unmet needs.
Session Name: B59 - BREAKING BAD: NEW DRUGS AND FORMULATIONS FOR PULMONARY HYPERTENSION AND RV FAILURE
Poster Title: A Phase I Clinical Trial Assessing the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of NTP42:KVA4, a Novel Thromboxane Receptor Antagonist, in Healthy Subjects
Poster Number: P212
Date: Monday May 22, 2023
Presenting Time: 11:30 AM - 1:15 PM
The ATS International Conference is one of the most prestigious annual events in the pulmonary medicine calendar, attracting 14,000+ clinical practitioners, scientific researchers, and other stakeholders each year.
During the conference, ATXA's poster and accompanying audio commentary will be available to view on the ATS 2023 Virtual Portal (registration required). A copy of the conference poster will also be made available in the “Our Publications” section of ATXA’s website at atxatherapeutics.com.