BNC210 for Social Anxiety Disorder

(AFFIRM-1 Trial)

No longer recruiting at 19 trial locations

Overseen By BNC210 Clinical Studies Bionomics Limited

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Bionomics Limited

Must not be taking: Psychotropics, Benzodiazepines

Disqualifiers: Bipolar, Schizophrenia, Alcohol-use, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, BNC210, to determine its effectiveness in reducing anxiety in individuals with social anxiety disorder. Researchers aim to discover if a single dose of BNC210 can lower anxiety during a specific task compared to a placebo (a pill with no active drug). Participants officially diagnosed with social anxiety disorder and who frequently experience anxiety in social situations might be suitable candidates. As a Phase 3 trial, this study serves as the final step before FDA approval, providing participants an opportunity to contribute to a potentially groundbreaking treatment for social anxiety disorder.

Will I have to stop taking my current medications?

Yes, you will need to stop taking psychotropic medications (drugs that affect your mind, emotions, and behavior) at least 30 days before the screening, and you must not use benzodiazepines daily for 90 days before the screening.

Is there any evidence suggesting that BNC210 is likely to be safe for humans?

Research has shown that BNC210 is usually well-tolerated. In earlier studies, individuals who took BNC210 for anxiety-related issues, such as panic attacks and generalized anxiety disorder, tolerated it well. These studies found that BNC210 quickly and effectively reduced anxiety without causing major side effects. However, as with any treatment, some people might experience side effects. Consulting healthcare professionals is important to understand the possible risks and benefits before joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for social anxiety disorder, like SSRIs and SNRIs, work by increasing serotonin or norepinephrine levels in the brain, which can take weeks to show effects. But BNC210 works differently, targeting the brain's GABA receptors to potentially reduce anxiety faster. Researchers are excited about BNC210 because it might offer quicker relief without the sedation and dependency issues of benzodiazepines. This unique mechanism of action could make BNC210 a promising alternative for those seeking rapid symptom relief.

What evidence suggests that BNC210 might be an effective treatment for social anxiety disorder?

Research has shown that BNC210, which participants in this trial may receive, might help treat social anxiety disorder. Studies found that just one dose of BNC210 lowered anxiety symptoms, measured using a simple scale that rates anxiety levels. In clinical trials, people who took BNC210 felt less anxious than those who took a placebo. These results suggest that BNC210 could be a good option for reducing anxiety in social situations. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with social anxiety disorder who score at least 60 on the Liebowitz Social Anxiety Scale, indicating significant symptoms. Participants must be able to swallow tablets and use suitable contraception as per protocol.

Inclusion Criteria

I am using birth control as required by the study.

I can swallow pills.

I have been diagnosed with social anxiety disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-3 weeks

1 visit (in-person)

Treatment

Participants receive a single dose of 225 mg BNC210 or placebo and participate in a behavioral assessment task

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

1 visit (phone/video conference)

What Are the Treatments Tested in This Trial?

Interventions

• BNC210

Trial Overview The study tests if a single dose of BNC210 can reduce anxiety levels more effectively than a placebo in people with social anxiety disorder. Anxiety reduction is measured during a specific task using the Subjective Units of Distress Scale.

How Is the Trial Designed?

Group I: 225 mg BNC210 Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Bionomics Limited

Lead Sponsor

Trials

8

Recruited

1,100+

Published Research Related to This Trial

In an 8-week study involving 12 patients with social anxiety disorder, olanzapine showed significant improvement compared to placebo on key anxiety measures, indicating its potential efficacy as a treatment.

Both olanzapine and placebo were well tolerated, with olanzapine causing more drowsiness and dry mouth but negligible weight gain, suggesting a favorable safety profile for further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of olanzapine in social anxiety disorder: a pilot study. Barnett, SD., Kramer, ML., Casat, CD., et al.[2018]

A new, comprehensive treatment for severe social phobia has shown effectiveness in a pilot study, particularly for individuals with co-occurring mental health conditions.

The treatment resulted in significant improvements across various outcome measures, highlighting the importance of a multifaceted approach to effectively address social phobia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multicomponent behavioral treatment for social phobia: social effectiveness therapy. Turner, SM., Beidel, DC., Cooley, MR., et al.[2019]

A systematic review of 51 randomized controlled trials involving 9914 participants found that pharmacotherapy for social anxiety disorder (SAD) is effective, with over 55% of participants responding positively to treatment after an average of 12 weeks.

Selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) were identified as the most effective and well-tolerated medication classes for SAD, while beta-blockers showed insufficient evidence for treating performance anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacotherapy for social anxiety disorder: a systematic review. Ipser, JC., Kariuki, CM., Stein, DJ.[2018]

A systematic review of 27 clinical trials involving second-generation antidepressants (SGA) showed that these medications significantly reduce symptoms of social anxiety disorder (SAD) compared to placebo, with a mean reduction in Liebowitz Social Anxiety Scale scores of -11.9.

The analysis indicated a 62% increase in treatment response for patients using SGAs, but no significant differences in efficacy were found among the various second-generation antidepressants tested.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Second-generation antidepressants in social anxiety disorder: meta-analysis of controlled clinical trials. de Menezes, GB., Coutinho, ES., Fontenelle, LF., et al.[2021]

In a 12-week open trial with 21 patients suffering from social phobia, buspirone showed modest efficacy, with 47% of participants rated as much to very much improved in their symptoms by the end of the study.

Among those who tolerated higher doses of 45 mg/day or more, 67% experienced significant improvement, indicating that higher doses may enhance the treatment's effectiveness for social phobia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Buspirone in social phobia. Schneier, FR., Saoud, JB., Campeas, R., et al.[2013]

The adapted 'Bergen 4-Day Treatment' for severe social anxiety disorder led to a significant 48% reduction in symptoms for a 16-year-old girl after just three days of treatment.

At the 28-month follow-up, the girl no longer met the diagnostic criteria for social anxiety disorder, indicating the long-term efficacy of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two-year longitudinal case study of intensive exposure treatment in an adolescent girl with social anxiety disorder. Haukeli, K., Edlund, K.[2022]

Patients with early-onset social anxiety disorder (SAD) are more likely to experience inactivity, have a generalized subtype of social phobia, and present with psychiatric comorbidities compared to those with late-onset SAD, indicating a distinct clinical profile.

Despite these differences in presentation, both early-onset and late-onset patients showed similar severity of symptoms and therapeutic responses after at least ten weeks of drug treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early-onset social anxiety disorder in adults: clinical and therapeutic features. Menezes, GB., Fontenelle, LF., Versiani, M.[2019]

Selective serotonin reuptake inhibitors (SSRIs) are currently considered the first-line treatment for social anxiety disorder due to their proven safety, tolerability, and efficacy.

Other medications like clonazepam, bromazepam, and gabapentin show potential efficacy similar to SSRIs, but more research is needed to confirm their effectiveness, while phenelzine is reserved for cases that do not respond to SSRIs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacotherapy of social anxiety disorder. Blanco, C., Antia, SX., Liebowitz, MR.[2022]

Social anxiety disorder (SAD) is a chronic condition that often begins in adolescence and can persist throughout life if untreated, with a significant number of patients also experiencing comorbid mental health issues.

Selective serotonin reuptake inhibitors (SSRIs) have emerged as the first-line treatment for SAD due to their proven safety, tolerability, and efficacy, while ongoing research aims to improve treatment outcomes and prevent relapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating neurobiology and psychopathology into evidence-based treatment of social anxiety disorder. Liebowitz, MR., Ninan, PT., Schneier, FR., et al.[2022]

In a study of 200 bipolar disorder patients, 17.5% were found to have comorbid social anxiety disorder (SAD), which was linked to more severe episodes and an earlier onset of bipolar disorder.

Despite the increased severity of episodes in patients with SAD, there was no significant difference in treatment response to mood stabilizers like lithium and anticonvulsants between those with and without SAD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of clinical and sociodemographic features of bipolar disorder patients with those of social anxiety disorder patients comorbid with bipolar disorder in Turkey. Berkol, TD., Kırlı, E., Islam, S., et al.[2018]

Citations

1. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/519095

Efficacy of BNC210 in Acute, As-needed Treatment ... The purpose of the study is to evaluate the effect of a single, acute dose of BNC210 compared to placebo on reducing the severity of anxiety ...

2. pharmaceutical-technology.com pharmaceutical-technology.com/data-insights/bnc-210-bionomics-social-anxiety-disorder-sad-social-phobia-likelihood-of-approval/

BNC-210 by Bionomics for Social Anxiety Disorder (SAD/ ... BNC-210 (IW-2143) is under development for the treatment of agitation (anxiety disorder), post-traumatic stress disorder, social anxiety ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7786299/

Pharmacotherapy of Anxiety Disorders: Current and Emerging ... Efficacy of pregabalin in generalized social anxiety disorder: results of a double-blind, placebo-controlled, fixed-dose study. Int Clin Psychopharmacol ...

4. globaldata.com globaldata.com/store/report/bnc-210-in-social-anxiety-disorder-sad-social-phobia-loa-innovation-and-trend-analysis/

BNC-210 in Social Anxiety Disorder (SAD/Social Phobia ... This report provides you with the data that allows you to track and predict the specific likelihood of approval (LOA) and phase transition success rate (PTSR) ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11991790/

Anxiety disorders, PTSD and OCD: systematic review of ... Trials have shown a reduction in social anxiety after receiving two puffs in each nostril. Preliminary findings. A phase II multicentre trial observed the ...

6. synapse.patsnap.com synapse.patsnap.com/drug/ca1840632fb24a8291a57242a61661af

Sitmutolimod - Drug Targets, Indications, Patents BNC210 has demonstrated rapid-onset, broad and meaningful anti-anxiety effects in completed clinical trials in panic attacks, generalized anxiety disorder (GAD) ...

7. go.drugbank.com go.drugbank.com/drugs/DB19048

BNC-210: Uses, Interactions, Mechanism of Action Improve decision support & research outcomes with our structured adverse effects data. ... Social Anxiety Disorder (SAD) · 1, somestatus, stop ...