BNC210 · program
BNC210 (soclenicant) for Social anxiety disorder
Indications for BNC210: Social anxiety disorder · Discontinued Post-traumatic stress disorder · Phase 2
Oral alpha7-nAChR negative allosteric modulator developed for the acute, as-needed treatment of anxiety in social anxiety disorder (SAD). The Phase 3 AFFIRM-1 trial (NCT06510504; n=370; single acute dose of 225 mg BNC210 vs placebo, 1:1) used a public speaking challenge model: subjects were dosed ~1 hour before being introduced to the challenge, given ~2 minutes to prepare (anticipation phase), then delivered a 5-minute speech before a small audience (performance phase). On 20 October 2025 Neuphoria announced AFFIRM-1 MISSED its primary endpoint - change from baseline to the average of the performance-phase Subjective Units of Distress Scale (SUDS) score during the public speaking challenge - and that analyses of secondary endpoints did not demonstrate statistically significant differences. BNC210 safety/tolerability remained favorable. Based on these results, Neuphoria DISCONTINUED further development of the SAD program and launched a full strategic review of its operations and portfolio; the company indicated it would separately evaluate next steps for BNC210 in PTSD (where chronic daily dosing had been positive). The SAD program is discontinued.
Development timeline
- missedPhase 3 AFFIRM-1 missed its primary SUDS endpoint in social anxiety disorder; Neuphoria discontinues the SAD program.↗
- AFFIRM-1 reaches primary completion (11 Sep 2025); 370 participants enrolled (actual). Trial record marked Completed on ClinicalTrials.gov.
- Phase 3 AFFIRM-1 (NCT06510504) in social anxiety disorder begins (study start 6 Aug 2024). Randomized, double-blind, placebo-controlled, single acute as-needed dose of 225 mg BNC210 vs placebo evaluated in a public speaking challenge model; primary endpoint = change from baseline in average performance-phase SUDS. Lead sponsor Bionomics Limited (Neuphoria Therapeutics).
Readouts
- 2025-10-20ReportedTopline datamissedNCT06510504
Phase 3 AFFIRM-1 missed its primary SUDS endpoint in social anxiety disorder; Neuphoria discontinues the SAD program. ↗
Clinical trials in Social anxiety disorder
NCT06510504AFFIRM-1Phase 3Completedn=370
A Phase 3, Randomized, Double-blind, 2-arm, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of BNC210 for the Acute, As-needed Treatment of Anxiety in Adults With Social Anxiety Disorder (AFFIRM-1)
missedprimaryChange from baseline in average performance-phase SUDS (Subjective Units of Distress Scale) during the public speaking challenge
AFFIRM-1 did not meet its primary endpoint: a single acute as-needed 225 mg dose of BNC210 did not significantly reduce the average performance-phase SUDS score during the public speaking challenge versus placebo. Topline announcement; quantitative effect size and p-value not disclosed in the company PR.
pendingsafetySafety / tolerability
The safety and tolerability profile of BNC210 continued to be favorable and was consistent with previously reported studies. No detailed adverse-event tabulation disclosed in the topline PR; outcome marked pending as full safety data have not been published.
missedsecondarySecondary efficacy endpoints (social anxiety / distress measures)
Analyses of secondary endpoints did not demonstrate statistically significant differences between BNC210 and placebo.
Formulations
| Formulation | Route | Regimen | Pharmacokinetics |
|---|---|---|---|
| BNC210 oral tablet (as-needed, SAD)spray-dried dispersion solid dose tablet 225 mg or 675 mg single as-needed dose (PREVAIL Phase 2, acute) | Oral | Single dose | Tmax 2 h |
Mechanism of action
Selective negative allosteric modulator (NAM) of the alpha-7 nicotinic acetylcholine receptor (alpha7 nAChR; CHRNA7), partially inhibiting alpha7 channel activation while sparing alpha4beta2 nAChR signalling. By dampening alpha7-mediated cholinergic tone in fear/stress circuitry it produces anxiolytic and PTSD-symptom-reducing effects without sedation or dependence. No quantitative binding/inhibitory constant for the NAM action is published in IUPHAR/GtoPdb or ChEMBL.
| Target | Action | Affinity |
|---|---|---|
| alpha7 nAChRprimaryCHRNA7 | NAM | —ⓘ |
← Full BNC210 compound page (identity, identifiers, all indications)
Sources
- A phase 2, placebo-controlled study to evaluate the efficacy and safety of BNC210 for acute, as-needed treatment of social anxiety disorder (SAD) - The PREVAIL study — PubMed (Psychiatry Research)
- AFFIRM-1: Phase 3 study of BNC210 for acute as-needed treatment of anxiety in social anxiety disorder (NCT06510504) — ClinicalTrials.gov
- Neuphoria Therapeutics Provides Update on AFFIRM-1 Phase 3 Trial Evaluating BNC210 for the Acute Treatment of Social Anxiety Disorder — Neuphoria Therapeutics, Inc. (GlobeNewswire)
- Soclenicant / BNC210 (ligand 14250) - alpha7 nicotinic ACh receptor negative allosteric modulator — IUPHAR/BPS Guide to Pharmacology