Inhaled combination therapies for pulmonary fibrosis

Proprietary dry-powder inhaled therapies for pulmonary fibrosis and interstitial lung disease, built on the SPRAYE™ platform.

Inhaled combination pipeline

Each SPRAYE™ combination is designed to put two active ingredients into every particle, so both reach the lung together in one puff. All programs are investigational. Approvals mentioned below refer to each drug on its own, in its current form, not to any combination.

Combination 1: pirfenidone + nintedanibPirfenidone with nintedanib (Ofev, Boehringer Ingelheim). eSpraye's target indications: IPF, PF-ILD and SSc-ILD. A deuterated pirfenidone is also part of eSpraye's program. Formulated.
Partnering
Combination 2: ensifentrine + nintedanibEnsifentrine (Ohtuvayre, now Merck's after its October 2025 acquisition of Verona Pharma) is a dual PDE3/PDE4 inhibitor, FDA-approved as a nebulized maintenance treatment for COPD. Nintedanib (Ofev, Boehringer Ingelheim) is an FDA-approved oral kinase inhibitor for fibrosing lung disease. eSpraye's target indications: IPF and PPF. A deuterated ensifentrine is also part of eSpraye's program. Formulated. Designed for one puff twice daily.
Lead program
Combination 3: treprostinil palmitil + nintedanibTreprostinil palmitil is an investigational prostacyclin analog that Insmed is developing as an inhalation powder for pulmonary hypertension associated with ILD; it is not approved. eSpraye's aim is a once-daily combination for ILD more broadly. Formulation initiated.
Partnering
Why these combinations

Oral pirfenidone and nintedanib have modest efficacy and GI side effects that limit combining them. The thinking behind SPRAYE™ is that delivering drugs straight to the lung may widen the therapeutic index and make combinations practical. Combination 2 pairs nintedanib's antifibrotic action with the anti-inflammatory and bronchodilator activity of a PDE3/PDE4 inhibitor.

Intellectual property and development plan

Patent applications have been filed covering all three combinations. For Combination 2, the plan is a Phase 1 study in Australia to establish safety of the doses and the ensifentrine-to-nintedanib ratio, followed by pre-IND meetings with FDA, then Phase 2b/3 in Australia, the US and Europe, using a 505(b)(2) / EMA hybrid pathway. These are plans, not commitments.