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更新于：2026-07-04
Sitmutolimod
更新于：2026-07-04
概要
基本信息
原研机构 |
非在研机构- |
最高研发阶段临床3期 |
首次获批日期- |
最高研发阶段(中国)- |
特殊审评快速通道 (美国) |
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结构/序列
分子式C24H26N4O3 |
InChIKeyZAEIHDZLLJCJFP-UHFFFAOYSA-N |
CAS号1020634-41-6 |
Sequence Code 453693544
来源: *****
关联
10
项与 Sitmutolimod 相关的临床试验NCT06510504
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
NCT05193409
A Phase 2, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of BNC210 Compared to Placebo for the Acute Treatment of Social Anxiety Disorder
NCT04951076
A Phase 2b, Randomized, Double Blind, Two Arm Study to Investigate the Effects of BNC210 Tablet Formulation Compared to Placebo in Adults With Post-Traumatic Stress Disorder (PTSD)
100 项与 Sitmutolimod 相关的临床结果
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100 项与 Sitmutolimod 相关的转化医学
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100 项与 Sitmutolimod 相关的专利（医药）
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9
项与 Sitmutolimod 相关的文献（医药）2026-02-01Clinical Pharmacology in Drug Development
The Pathway to Proof‐of‐Concept for BNC210, a Negative Allosteric Modulator of the Alpha‐7 Nicotinic Acetylcholine Receptor (nAChR), for Treatment of Psychiatric Disease
Article
作者: Dharam Paul ; Spyros Papapetropoulos ; Mark Smith ; Philippe Danjou ; Julia Crossman ; Paul Rolan ; Elizabeth Doolin ; Michael Odontiadis
Abstract:
BNC210 is an investigational small molecule selective negative allosteric modulator of the alpha‐7 nicotinic acetylcholine receptor (α7 nAChR). It is an anxiolytic compound with a novel mechanism of action. In a series of Phase 1 clinical trials in healthy volunteers, psychometric test batteries showed that BNC210 did not cause attention, cognition, or memory impairment, negative effects on mood or emotional stability, sedation, or addiction, ruling out undesirable side effects of known anxiolytic compounds. In healthy volunteers, target engagement at the α7 nAChR was demonstrated in a nicotine shift assay using quantitative electroencephalography, and BNC210 demonstrated improvement in panic‐like symptoms in a cholecystokinin tetrapeptide panic model. Initial clinical trials used an aqueous suspension formulation of BNC210 to cover a wide dosage range; however, its pharmacokinetic parameters were consistent with solubility‐limited absorption and a significant food effect. A dispersible tablet formulation was then developed with improved bioavailability and is being used in Phases 2 and 3 clinical trials. Collectively, the Phase 1 data demonstrated desired properties of BNC210 supporting proof‐of‐concept clinical trials. BNC210 is currently being developed for acute, as‐needed treatment of social anxiety disorder and chronic treatment of post‐traumatic stress disorder.
2025-04-01PSYCHIATRY RESEARCH
A phase 2, placebo-controlled study to evaluate the efficacy and safety of BNC210, an alpha-7 nicotinic receptor negative allosteric modulator, for acute, as-needed treatment of social anxiety disorder (SAD) – The PREVAIL study
Article
作者: Doolin, Elizabeth ; Rolan, Paul ; Paul, Dharam ; Jaros, Mark ; Odontiadis, Michael ; Taylor, Charles ; Stein, Murray B ; Papapetropoulos, Spyros
Social anxiety disorder (SAD) is a chronic, debilitating, and prevalent neuropsychiatric condition for which an acute, as-needed therapy is an unmet medical need. This Phase 2 study evaluated a potential novel, fast-acting, anxiolytic, BNC210, in SAD patients (NCT05193409). PREVAIL was a placebo-controlled, acute dose study of 225 mg and 675 mg BNC210 in 151 adult participants with SAD. Anxiety was evaluated by self-report efficacy scales during the anticipation and performance phases of a simulated public speaking challenge. Safety data were collected. Least squares mean ± standard error (SE) differences compared to placebo for the Subjective Units of Distress Scale (SUDS) scores for the change from baseline to the average of the performance phase were -6.6 ± 4.75 for 225 mg BNC210 and -4.8 ± 4.73 for 675 mg BNC210 (not significant). A post hoc analysis of SUDS scores evaluating combined BNC210 doses and speaking challenge phases (anticipation and performance) revealed a nominally statistically significant reduction compared to placebo (p = 0.044; effect size 0.36). Both dose levels of BNC210 demonstrated a favorable safety profile. PREVAIL supported further testing of 225 mg BNC210 as a potential safe and effective anxiolytic for acute, as-needed treatment of SAD. A Phase 3 trial is ongoing.
2025-01-01NEJM evidence
BNC210, an α7 Nicotinic Receptor Modulator, in Post-Traumatic Stress Disorder
Article
作者: Paul, Dharam ; Doolin, Elizabeth ; Rolan, Paul ; Papapetropoulos, Spyridon ; O’Connor, Susan ; Stein, Murray B. ; Jaros, Mark ; Odontiadis, Michael
BACKGROUND:
Post-traumatic stress disorder (PTSD) is a serious, debilitating, and prevalent psychiatric condition occurring in people who are traumatized and experience intense, disturbing thoughts and feelings that persist. BNC210 is a novel α7 nicotinic acetylcholine receptor-negative allosteric modulator developed to treat PTSD.
METHODS:
ATTUNE was a randomized, double-blind, phase 2b, placebo-controlled trial. Patients between 18 and 75 years of age with a current PTSD diagnosis and a Clinician-Administered PTSD Scale for DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) (CAPS-5) total symptom severity score of 30 or more were eligible (range: 0 to 80; in all scales used in this trial a higher score indicates a more severe condition). We randomly assigned patients 1:1 to a BNC210 dose of 900 mg twice daily or placebo for 12 weeks. The primary end point was a change from baseline to week 12 in CAPS-5 total score for BNC210 versus placebo.
RESULTS:
In the modified intent-to-treat population (n=182), an improvement in the CAPS-5 total score was observed with BNC210 compared with placebo (least squares [LS] mean difference: -4.03; Cohen's d effect size: 0.40; P=0.048) at week 12. A LS mean difference in CAPS-5 score of -4.11 was observed as early as week 4. The LS mean difference to week 12 for depressive symptoms measured on the Montgomery-Åsberg Depression Rating Scale (range: 0 to 60; minimal clinically important difference [MCID] ≥2]) was -3.19 and for sleep measured on the Insomnia Severity Index (range: 0 to 28; MCID 6) was -2.19. Treatment-emergent adverse events (AEs) occurred in 70 (66.7%) patients in the BNC210 group and 56 (53.8%) in the placebo group, most commonly headache, nausea, fatigue, and hepatic enzyme elevations. In the BNC210 treatment group, 21 patients withdrew from treatment for AEs, while 10 did so in the placebo group. There were no serious AEs or deaths reported for the BNC210 group.
CONCLUSIONS:
BNC210 improved PTSD symptom severity at week 12 with indications of effect as early as week 4. Our trial establishes equipoise for additional larger trials that are needed to determine the clinical utility of BNC210 for the treatment of PTSD. (Funded by Bionomics Limited; ClinicalTrials.gov number, NCT04951076.).
100 项与 Sitmutolimod 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
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研发状态
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 焦虑症 | 临床3期 | 美国 | 2024-08-06 | |
| 社交恐怖症 | 临床3期 | 美国 | 2024-08-06 | |
| 躁动 | 临床2期 | 澳大利亚 | 2018-05-17 | |
| 创伤后应激障碍 | 临床2期 | 美国 | 2016-06-30 | |
| 创伤后应激障碍 | 临床2期 | 澳大利亚 | 2016-06-30 | |
| 抑郁症 | 临床1期 | - | - | |
| 季节性情感障碍 | 临床前 | 澳大利亚 | 2024-01-22 |
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临床结果
临床结果
适应症
分期
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临床3期 | 370 | (225 mg BNC210) | 齋選築窪糧憲範範壓積(積夢鹽鬱襯網網壓夢鬱) = 鬱窪淵窪鏇鏇壓餘衊鹽 蓋襯膚築齋構範窪廠憲 (夢壓顧觸蓋遞鹹顧鏇簾, 醖醖淵選遞鏇鏇構鏇糧 ~ 壓選製積淵憲顧鹽齋簾) 更多 | - | 2026-05-19 | ||
Placebo (Placebo) | 齋選築窪糧憲範範壓積(積夢鹽鬱襯網網壓夢鬱) = 糧艱鬱齋憲夢鏇願簾顧 蓋襯膚築齋構範窪廠憲 (夢壓顧觸蓋遞鹹顧鏇簾, 顧淵廠選窪繭鹹構糧選 ~ 繭齋齋窪築膚鑰觸廠範) 更多 | ||||||
临床3期 | - | 壓鏇膚襯醖夢獵網蓋窪(選廠膚鹹憲窪淵糧齋窪) = failed to hit 鏇齋鑰鬱夢壓鬱網壓鏇 (鏇觸夢積齋獵鏇醖衊積 ) 未达到 更多 | 不佳 | 2025-10-21 | |||
Placebo | |||||||
临床2期 | 151 | (225 mg BNC210) | 壓淵窪壓鏇製積網鑰蓋(鹹簾蓋鏇壓夢鬱簾鏇鏇) = 襯簾鏇構窪選醖夢憲膚 鬱鏇鹽遞壓醖壓壓窪糧 (夢遞顧糧醖構繭壓餘糧, 廠夢選鏇廠蓋窪餘蓋鑰 ~ 鏇範淵構觸淵獵鬱鬱壓) 更多 | - | 2025-03-18 | ||
(675 mg BNC210) | 壓淵窪壓鏇製積網鑰蓋(鹹簾蓋鏇壓夢鬱簾鏇鏇) = 醖窪鹽鏇衊壓選鬱衊築 鬱鏇鹽遞壓醖壓壓窪糧 (夢遞顧糧醖構繭壓餘糧, 膚齋顧選壓顧齋齋顧製 ~ 窪糧醖淵範繭糧蓋鹹齋) 更多 | ||||||
临床2期 | 212 | Placebo | 廠鑰顧鑰壓顧觸鬱積餘(壓鏇憲廠憲襯願鏇壓築) = 鏇製製鹽鏇選艱壓壓餘 齋鏇觸構壓夢構鬱鹹糧 (餘衊製構構觸鹹襯襯鬱, 1.469) 更多 | - | 2025-02-06 | ||
临床2期 | 182 | BNC210 900 mg twice daily | 鬱窪獵夢餘簾壓膚簾獵(齋廠糧襯繭積艱鏇憲鬱): Difference (LS Mean) = 4.03, P-Value = 0.048 更多 | 积极 | 2024-12-08 | ||
placebo | |||||||
临床2期 | - | 衊遞繭壓醖鑰製鬱淵憲(膚獵鬱願鏇築構範製築) = BNC210 225 mg and 675 mg demonstrated reduced anxiety in patients with moderate to severe SAD in a public speaking challenge compared to placebo. 顧製蓋觸網餘顧醖構廠 (廠鏇顧壓衊廠製窪憲遞 ) | 积极 | 2023-12-06 | |||
Placebo | |||||||
临床2期 | 193 | (BNC210 600 mg b.i.d.) | 獵範遞糧淵選範餘艱選(淵壓夢繭鬱餘夢獵窪淵) = 醖網鹽觸鬱餘衊繭壓鹹 觸遞蓋顧憲簾壓繭鏇構 (衊遞淵糧網繭鬱顧壓憲, 夢膚廠獵襯製簾窪齋鹽 ~ 網蓋鑰鑰簾範願蓋憲夢) 更多 | - | 2023-02-27 | ||
(BNC210 300 mg b.i.d.) | 獵範遞糧淵選範餘艱選(淵壓夢繭鬱餘夢獵窪淵) = 窪齋範鬱餘網網憲糧製 觸遞蓋顧憲簾壓繭鏇構 (衊遞淵糧網繭鬱顧壓憲, 觸鹽繭鑰膚淵艱積繭壓 ~ 醖膚廠夢憲選繭繭範鏇) 更多 |
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