Insmed’s TPIP PAH Therapy Advances to Phase III Following Positive Phase 2b Results

Insmed’s TPIP (treprostinil palmitil inhalation powder) therapy for pulmonary arterial hypertension (PAH) showed positive topline results in a Phase 2b clinical trial, meeting its primary and secondary endpoints3 4 5.

The trial demonstrated a 35% placebo-adjusted reduction in pulmonary vascular resistance (PVR) at week 16 (p<0.001), a 35.5-meter improvement in six-minute walk distance (6MWD) (p=0.003), and a 60% reduction in NT-proBNP, a cardiac stress biomarker (p<0.001)4 5.

Once-daily dosing of TPIP offers significant convenience for PAH patients compared to existing treatments, with 75% of patients reaching the maximum tested dose, indicating strong tolerability4.

Adverse events such as cough and headache were more frequent in the treatment group, but no deaths or major safety concerns were reported4.

Following these results, Insmed plans to initiate discussions with the FDA on the design of a Phase III trial, with testing expected to begin before the end of 20251 2.

Investor sentiment surged, with Insmed’s stock jumping 13.54% after the announcement, reflecting confidence in the therapy’s market potential5.