Clinical trials

Nocion clinical studies in chronic cough

Nocion is conducting clinical trials to assess whether taplucainium, delivered with a dry powder inhaler, can safely and effectively treat chronic cough in people who have not responded to prior treatments or the cause of their cough is unknown. This indication is called refractory or unexplained chronic cough (rCC/uCC).

Ongoing ASPIRE Phase 2b study in rCC/uCC

Nocion is conducting ASPIRE, a randomized, placebo-controlled Phase 2b study of taplucainium inhalation powder in 240 adults with rCC/uCC, measuring change in 24-hour cough frequency using VitaloJAK® cough counts as the primary endpoint. The study is being conducted in the U.S., Canada, the U.K., and EU and fully enrolled, with topline results expected Q3 2026.

ASPIRE: A Phase 2b study designed with regulatory alignment and clinically meaningful cough-count endpoints

Primary endpoint:

Change in 24-hour coughs/hour (VitaloJAK cough counts) from baseline to end of treatment

Key secondary endpoints:

Awake cough frequency
Cough severity VAS
Urge-to-cough VAS
LCQ
PGI-I
Safety

Exploratory continuous monitoring:

Hyfe CoughMonitor  to capture cough  patterns across the treatment  period

ASPIRE Phase 2b study design

More information about ASPIRE is available at clinicaltrials.gov

Completed studies

Three completed studies support the development of taplucainium in refractory and unexplained chronic cough. Across completed preclinical, Phase 1, Phase 2a and bridging studies, taplucainium consistently demonstrated the ability to achieve high lung exposure, a rapid onset of cough reduction and minimal systemic exposure supporting a favorable tolerability profile.

STUDY 1:

Phase 1

Participants: 80 healthy volunteers
Design: Single ascending dose and multiple ascending dose; once-daily dosing (nebulized)
Key takeaways: Well tolerated;  mild-to-moderate adverse events; no discontinuations; consistent PK profile and low systemic exposure

STUDY 2:

Phase 2a

Participants: 41 chronic cough participants
Design: Randomized crossover; once-daily nebulized dosing
Key takeaways: Rapid onset signal – 62% reduction in awake cough frequency observed within 15 minutes after first dose

STUDY 3:

DPI bridging study

Participants: Part 1: 12 healthy volunteers; Part 2: 12 people with chronic cough
Design: Evaluated transition from nebulized formulation to dry powder inhaler (DPI) intended for later stage development; once-daily dosing
Key takeaways: Supported tolerability and informed ASPIRE Phase 2b study design; saw cough reduction after 5 days

Compelling preclinical activity

~90–100% cough suppression in validated preclinical cough models.

Rapid clinical signal

Reduction in awake cough frequency observed within 15 minutes after dosing in Phase 2a.

Early efficacy signal

In a multi-day DPI bridging study, taplucainium demonstrated cough frequency reduction at Day 5 comparable to camlipixant’s Phase 2b Day 28 results.

Consistent safety profile

Well tolerated across three completed studies and no treatment discontinuations due to adverse events.

Designed for local activity

High lung exposure with ~500–700x lower systemic exposure in preclinical studies.

Upcoming clinical milestone

Phase 2b ASPIRE study ongoing with topline data expected mid-2026.

In the Phase 2a study, immediate decrease in cough counts  after single dose of taplucainium

In the DPI bridging study, taplucainium day 5 efficacy comparable  to day 28 efficacy in camlipixant Phase 2b

Learn more about taplucainium

Charging forward