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I'm Oksana Shlobin. I’m Medical Director of Pulmonary Hypertension Program for Inova Fairfax Hospital. And I'm here to discuss inhale treprostinil for treatment of PAH in the setting of interstitial lung diseases.
INCREASE study was a pivotal study that looked at inhaled treprostinil via an iNEB device for treatment of patients with PH-ILD. As you can see on the slide, the primary endpoint was change in 6-minute walk test distance, and it was statistically significant with a peak 6-minute walk test difference of 31 meters, it was a placebo-corrected 6-minute walk test difference. The further studies show that the effect of the drug appear dose related with the goal dose of more than 9 breaths 4 times a day.
If you can look at the left, this graph represent a number of patients both with clinical improvement and clinical worsening based on grouping at 4 weeks. And the graph on the right shows the same thing based on the last dosage grouping. In both analyses, it appears that patients who received more than 9 breaths 4 times a day of inhaled treprostinil fared much better across the categories.
The other outcome that was looked at is hospitalization due to cardiopulmonary indication, and decrease in 6-minute walk test of more than 15% from baseline. And again, patients who received inhaled treprostinil fared better in both of these parameters.
The graph on the on the right, the Kaplan-Meier curve, looks at decreased risk and time to first and second disease progression events. And as apparent on the slide, patients who were on inhale treprostinil, did better in both categories.
This is a waterfall slide looking at the incidence of multiple disease progression events for patients with different subgroups of interstitial lung disease. Each rectangle of a particular color represents a certain type of the event. So for example, blue is the decline in 6-minute walk test distance by more than 15 meters. Red for example, is lung transplantation. And green is decline in forced vital capacity by more than 10%. Visually you can see that patients who were on inhale treprostinil had significantly fewer events than patients who were on placebo across all of the categories or subgroups of the disease. So IIP group is here on the upper left, and then IPF, CPFE, and connective tissue diseases.
There is another version of treprostinil which is treprostinil DPI. One of them is made by United Therapeutics and it's called Tyvaso. It is a 1% treprostinil powder absorbed in the carrier particles consisting of the FDKP. And another is Yutrepia. It is manufactured using proprietary PRINT nanoparticle technology, and the company states that the particles are precise and uniform in size, monodisperse, they have minimal agglomeration, allowing thus for efficient delivery to the lungs by DPI, with a low resistance and high robustness. Tyvaso DPI is available for commercial use in both Group 1 and PH-ILD. And Yutrepia was approved by FDA but is not commercially available at this point.
Liquidia DPI is studying Yutrepia in a small study of ILD PH patients. Using DPI usually is associated with improvement in compliance because it is much easier to use than the INF technology.
In summary, inhaled treprostinil is the first treatment that was FDA approved for treatment of patients with pulmonary hypertension due to interstitial lung diseases with salutary effects on 6-minute walk test and various time to clinical worsening events as defined in the study.
Thank you very much.
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