Nocion Therapeutics, Inc., a biopharmaceutical company developing novel small molecule therapies that selectively silence activated sensory neurons, today announced that its Phase 2b ASPIRE trial evaluating taplucainium for the treatment of refractory or unexplained chronic cough (rCC/uCC) is fully enrolled.
“Fully enrolling the Phase 2b ASPIRE trial represents a major milestone on the path to delivering a transformative new therapy for patients with chronic cough,” said Matthew Frankel, M.D., MBA, Chief Medical Officer of Nocion Therapeutics. “Taplucainium’s differentiated mechanism has the potential to deliver fast-acting and long-lasting relief by addressing the underlying drivers of chronic cough. The rapid pace of enrollment underscores the strong demand among clinicians and patients for a safe and effective treatment for this undertreated, debilitating condition. With the Phase 2b trial now fully enrolled, we are on track to report topline data in Q3 2026 to support a potential registrational program for taplucainium.”
ASPIRE is a Phase 2b, randomized, double-blind, placebo-controlled study investigating the efficacy, safety, and tolerability of taplucainium inhalation powder once daily in adults with rCC/uCC. The study has reached its target enrollment of 240 patients across more than 100 sites in the U.S., Canada, U.K. and EU. Patients were randomized into one of four groups either receiving taplucainium 1 mg, 3 mg, 6 mg, or placebo over 1 month of treatment. The primary endpoint is the change in 24-hour coughs per hour from baseline to end of treatment (as measured by VitaloJAK® Cough Counts). Key secondary endpoints include change in awake coughs, cough severity, and urge to cough.
Additional information about the ongoing ASPIRE study can be found at clinicaltrials.gov (Identifier: NCT06504446).
About Chronic Cough
Chronic cough is defined as cough lasting more than eight weeks and is associated with significant physical, social, and psychosocial burden. It is estimated that approximately 27 million adults in the United States suffer from chronic cough, of which approximately 9 million suffer from refractory or unexplained chronic cough (rCC/uCC). No new therapies have been approved for use in the U.S. in the last 65 years, and chronic cough is often treated with off-label approaches that may be inadequate or ineffective.
About Taplucainium
Taplucainium (formerly NTX-1175) inhalation powder is a proprietary molecule in the novel class of charged sodium channel blockers (CSCBs) designed to selectively silence activated/inflamed nociceptors while having minimal local off-target effects or systemic exposure. It is delivered once daily and in prior studies, has shown a rapid onset of effect for silencing cough with a favorable adverse event profile. Unlike other investigational cough therapies, such as P2X3 antagonists that target a specific large pore channel (LPC), taplucainium is designed to gain access to airway nociceptors through open LPCs and then inhibit the sodium channels responsible for initiating the pathological cough response. This broader mechanism has shown superior antitussive effects in preclinical models of cough. Together with preliminary safety and efficacy data from earlier-stage clinical work, these findings support evaluation of taplucainium in cough indications beyond chronic cough.
About Nocion
Nocion Therapeutics is a clinical-stage private biopharmaceutical company developing nocions™, a novel class of small molecule charged sodium channel blockers (CSCBs), designed to selectively silence activated sensory neurons by delivering precision therapies that act directly on the nerve fibers that underlie disease. Based on foundational insights from Harvard’s Office of Technology Development, the Company aims to deliver long-awaited relief for millions of patients suffering from underserved conditions including chronic cough, itch, pain, and neurogenic inflammation. Nocion’s lead clinical program, taplucainium inhalation powder, is a first-in-class, locally delivered nocion currently in Phase 2b clinical development for refractory or unexplained chronic cough (rCC/uCC). The Company is also advancing a platform of nocion-based medicines to address additional debilitating conditions where overactive sensory nerves cause lasting harm. For more information, please follow Nocion on LinkedIn and X, as well as on our website: www.nociontx.com.
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