TETON-1 & -2 phase 3 studies of treprostinil in IPF – baseline characteristics: Steven D. Nathan, ATS 2023

The TETON program consists of two currently recruiting phase 3 randomized, double-blind, placebo-controlled studies that are investigating the efficacy and safety of inhaled treprostinil in idiopathic pulmonary fibrosis (NCT04708782, NCT05255991). It was a pleasure to talk with Dr. Steven D. Nathan (Inova Fairfax Hospital, Falls Church, VA, USA) around the aims and design of the TETON program and the preliminary baseline characteristics of subjects enrolled.

The abstract ‘Preliminary Baseline Data From the Teton Phase 3 Clinical Trials of Inhaled Treprostinil in the Treatment of Idiopathic Pulmonary Fibrosis. ‘ (Abstract number: P766) was presented at ATS 2023, 19-24 May 2023.

Questions

1. What clinical data surrounds the use of treprostinil in interstitial lung disease? (0:18)
2. What were the aims and design of the TETON program? (1:46)
3. What are the preliminary baseline characteristics of subjects enrolled in TETON? (2:17)

Disclosures: Steven D. Nathan discloses consulting for United Therapeutics, Boerhinger-Ingelehim, Bellerophon, Gossamer, Merck, Fibrogen, and Pliant; receiving grant/research support from Tvardi; serving on advisory boards for Fibrogen, Boerhinger-Ingeheim, and United Therapeutics; and participating on speaker’s bureaus with United Therapeutics and Boerhinger-Ingelheim.

Support: Interview and filming supported by Touch Medical Media Ltd. Interview conducted by Victoria Jones.

Filmed in coverage of the ATS Annual Meeting.

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Transcript

What clinical data surrounds the use of treprostinil in interstitial lung disease? (00:19)

Inhaled treprostinil has been approved for many years for pulmonary arterial hypertension and was recently studied for pulmonary hypertension complicating fibrosing interstitial lung disease. This was the INCREASE study that was published in the New England Journal of Medicine in 2021. This was a positive study based on the primary endpoint of improvement in the six-minute walk distance at sixteen weeks. An interesting aspect of the INCREASE study was that we looked at spirometry as a safety endpoint and lo and behold, what we found was that the group that got inhaled treprostinil had better forced vital capacities at the end of the sixteen-week period than the group that got placebo. So this raised the intriguing notion that maybe inhaled treprostinil has independent antifibrotic properties and digging through the literature, there is a good biologic basis for how treprostinil might have antifibrotic properties through various prostacyclin receptors. So what resulted from that is that really informed the foundation for the TETON studies, which are currently ongoing. There’s TETON-1, which is primarily in the US, and TETON-2, which is now underway in Europe, Asia, and Australia, as well as New Zealand.

What were the aims and design of the TETON program? (01:46)

So what these studies are geared towards is looking at the antifibrotic properties of inhaled teprostinil. Typical IPF study, a fifty-two-week study, double-blind, randomized control with FVC being the primary endpoint at fifty-two weeks, what’s interesting though is that the study is totally agnostic as to the presence or absence of pulmonary hypertension and is looking purely at the antifibrotic properties of this agent.

What are the preliminary baseline characteristics of subjects enrolled in TETON? (02:16)

What we’re seeing in terms of the baseline characteristics of the patients in the TETON study is very similar to what we’ve seen in many of the IPF clinical trials – mostly males, more elderly, and with baseline FVCs around about seventy-five percent of predicted. About twenty percent of them are on supplemental oxygen, and eighty percent of them remain on room air, which is very interesting because that’s the mirror opposite of what the patient cohort was like in the INCREASE study, which was generally a sicker population, where about seventy-five, eighty percent of them were on supplemental oxygen. So generally, the study is targeting a milder group than the patients in the INCREASE study but reflects the general characteristics of patients enrolled in most of the IPF clinical trials currently ongoing.

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