To observe the pharmacokinetic and pharmacodynamic characteristics of a single dose of bencyclidine bromide inhalation aerosol in patients with chronic obstructive pulmonary disease (COPD) and provide a basis for the formulation of a dosing regimen for Phase II clinical trials

Start Date15 Dec 2021

Sponsor / Collaborator

Beijing Jiashi Lianbo Medicine Technology Co., Ltd.

[+2]

CTR20211344 / Active, not recruitingPhase 3

苯环喹溴铵鼻喷雾剂治疗感冒引起的流涕、鼻塞、鼻痒和喷嚏症状的临床有效性和安全性的随机、双盲、安慰剂对照、多中心Ⅲ期临床试验

[Translation] A randomized, double-blind, placebo-controlled, multicenter phase III clinical trial of the clinical efficacy and safety of bencyclidine bromide nasal spray in the treatment of runny nose, nasal congestion, nasal itching and sneezing symptoms caused by colds

验证苯环喹溴铵鼻喷雾剂在180μg/次（90μg/喷，每次每侧鼻孔各1喷），每天4次的剂量下治疗感冒引起的流涕、鼻塞、鼻痒和喷嚏症状的有效性和安全性。

[Translation]

To verify the efficacy and safety of bencyclidine nasal spray at a dose of 180 μg/time (90 μg/spray, 1 spray in each nostril each time), 4 times a day, in the treatment of runny nose, nasal congestion, nasal itching and sneezing symptoms caused by colds.

Start Date28 Sep 2021

Sponsor / Collaborator

Silver Valley Pharmaceutical Co. Ltd.

NCT05038202 / Active, not recruitingPhase 4

Study on the Efficacy and Safety of Bencycloquidium Bromide Nasal Spray Alone or in Combination With Mometasone Furoate Aqueous Nasal Spray in the Treatment of Moderate-severe Persistent Allergic Rhinitis

450 subjects with moderate-severe persistent allergic rhinitis will be enrolled in the trial and divided into three groups for different treatments. Group A：Subjects with Bencycloquidium Bromide Nasal Spray, Group B：Subjects with Mometasone Furoate Aqueous Nasal Spray, Group C：Subjects with Bencycloquidium Bromide Nasal Spray in combination with Mometasone Furoate Aqueous Nasal Spray.The main purpose of the trial is to evaluate the efficacy of Bencycloquidium Bromide Nasal Spray alone or in combination with Mometasone Furoate Aqueous Nasal Spray in the treatment of moderate-severe persistent allergic rhinitis and rhinorrhea.

Start Date16 Jun 2021

Sponsor / Collaborator

Silver Valley Pharmaceutical Co. Ltd.

100 Clinical Results associated with Bencycloquidium Bromide

100 Translational Medicine associated with Bencycloquidium Bromide

100 Patents (Medical) associated with Bencycloquidium Bromide

Literatures (Medical) associated with Bencycloquidium Bromide

01 Jul 2023·Lin chuang er bi yan hou tou jing wai ke za zhi = Journal of clinical otorhinolaryngology, head, and neck surgery

[A multi-center observation of the therapeutic efficacy of Bencycloquidium bromide in the treatment of seasonal allergic rhinitis with predominant symptoms of rhinorrhea].

Article

Author: An, Fengyang ; Hu, Weini ; Zhu, Li ; Zhu, Dongdong ; Meng, Cuida ; Xu, Chiyu ; Xie, Lifeng ; Song, Yu ; Meng, Chao ; Zhang, Lei ; Zuo, Qiang ; Zhang, Yinghong ; Zhang, Tianhong ; Wang, Yuhui ; DU, Chen ; DU, Yali

Objective:To observe the efficacy and safety of the M receptor antagonist Bencycloquidium bromide nasal spray in treatment of seasonal allergic rhinitis with runny nose as the main symptom. Methods:From August 2021 to September 2021, 134 patients with seasonal allergic rhinitis were enrolled in the otolaryngology Outpatient Department of Peking University Third Hospital, First Affiliated Hospital of Harbin Medical University and China-Japanese Friendship Hospital of Jilin University, including 71 males and 63 females, with a median age of 38 years. TNSS score and visual analogue scale（VAS） of total nasal symptoms were observed during 2 weeks of treatment with Bencycloquidium bromide nasal spray. Results:TNSS score decreased from （8.89±3.31） on day 0 to （3.71±2.51） on day 14（P<0.001）, VAS score of nasal symptoms decreased from （24.86±7.40） on day 0 to （6.84±5.94） on day 14（P<0.001）, VAS score of rhinorrhoea decreased from （6.88±2.06） on day 0 to （1.91±1.81） on day 14（P<0.001）. Rhinoconjunctivitis quality of life questionnaire（RQLQ） score decreased from （94.63±33.35） on day 0 to （44.95±32.28） on day 14（P<0.001）. The incidence of adverse reaction was low and no serious adverse events occurred during the whole experiment. Conclusion:Bencycloquidium bromide nasal spray has significant efficacy and good safety in the treatment of seasonal allergic rhinitis.

01 Feb 2021·European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical SciencesQ2 · MEDICINE

Safety, Tolerability and Pharmacokinetics of Bencycloquidium Bromide, a Novel Inhaled Anticholinergic Bronchodilator, in Healthy Subjects: Results from Phase I Studies

Q2 · MEDICINE

Article

Author: Ding, Li ; Luo, Zhu ; Wang, Ying ; Hu, Chao ; Miao, Jia ; Pan, Yuanyuan ; Liang, Maozhi

BACKGROUND:

Bencycloquidium bromide (BCQB) is a novel inhaled anticholinergic bronchodilator with high selectivity for muscarinic M3 receptor. BCQB's potential utility of for therapy in Chronic obstructive pulmonary disease (COPD) has been indicated in pre-clinical studies.

PURPOSE:

To investigate the initial safety, tolerability and pharmacokinetics of BCQB delivered via pressurised Metered Dose Inhaler (pMDI) in healthy subjects.

METHODS:

This study consisted of single-ascending-dose (SAD), multiple-ascending-dose (MAD) tolerability study periods, and single- plus multiple-dose pharmacokinetic study periods. Randomized, double-blind, placebo-controlled, dose-escalating tolerability and pharmacokinetic studies were conducted. Seventy-two healthy subjects were assigned 3:1 (BCQB: placebo) to 7 single-dose cohorts (125, 250, 500, 750, 1125, 1500 and 2000 μg) and 2 multiple-dose cohorts (1500 μg/d and 2000 μg/d). In the pharmacokinetic periods, 12 subjects were allocated three-way crossover to receive single dose of 250, 750 or 2000 μg BCQB, respectively. Subsequently, the same 12 subjects received multiple dose of 750 μg/d and 1000 μg/d for 7 days. Pharmacokinetic, safety and tolerability assessments were performed.

RESULTS:

BCQB administered by inhalation was well tolerated, especially with favorable cardiovascular safety profile. BCQB was rapidly absorbed into plasma after inhalation through pMDI, with peak concentrations achieved within 5 to 10 minutes. Repeated inhalation caused certain degree of accumulation with the accumulation ratio R_Cmax 2.50, R_AUC 3.49 for 3 times-a-day and R_Cmax 2.23, R_AUC 3.44 for 4 times-a-day, respectively. Twice-a-day or even once-a-day dosage could be suggested in phase II study. Sex didn't affect the pharmacokinetics of BCQB and dose adjustments based on sex is not anticipated in clinical use. Approximately 4% of the BCQB dose excreted unchanged in urine and liver metabolism is the main biotransformation route of BCQB in human.

CONCLUSIONS:

The results of our study provided the initial safety, tolerability and pharmacokinetic profiles of BCQB inhalation, and could enable further clinical development in COPD patients.

01 Nov 2020·European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck SurgeryQ3 · MEDICINE

Bencycloquidium bromide nasal spray is effective and safe for persistent allergic rhinitis: a phase III, multicenter, randomized, double-blinded, placebo-controlled clinical trial

Q3 · MEDICINE

Article

Author: Liang, Jianping ; Pan, Yuanyuan ; Zhang, Qinna ; Zhang, Xueyuan ; Chen, Jichuan ; Liu, Shixi ; Xue, Weiguo ; He, Gang ; Lin, Chang ; Lian, Zhuang ; Tan, Guolin ; Xiao, Xuping ; Jiang, Zihan ; Meng, Juan ; Hu, Guohua ; Guo, Mingli ; Dong, Pin ; Huang, Yongwang ; He, Jia ; Xiao, Hao

PURPOSE:

To investigate the efficacy and safety of bencycloquidium bromide nasal spray (BCQB) in patients with persistent allergic rhinitis (PAR).

METHODS:

We enrolled 720 patients from 15 hospitals across China and randomly assigned them into BCQB group or placebo group (90 μg per nostril qid) to receive a 4-week treatment. Visual analog scale (VAS) for rhinorrhea, sneezing, nasal congestion, itching and overall symptoms were recorded by patients every day. Anterior rhinoscopy scoring was completed by doctors on every visit. Adverse events were recorded in detail.

RESULTS:

A total of 354 and 351 patients were included in BCQB group and in placebo group. Baseline information was comparable. At the end of the trial, the decrease of VAS for rhinorrhea from baseline was 4.83 ± 2.35 and 2.46 ± 2.34 in BCQB group and placebo group, respectively (P < 0.001). The change ratio from baseline of VAS for rhinorrhea in BCQB group was 72.32%, higher than 31.03% in placebo group (P < 0.001). VAS for other symptoms and overall symptoms also improved significantly in the BCQB group, while no inter-group difference was found in anterior rhinoscopy scoring. The incidence of adverse reaction was similar between the two groups. Most reactions were mild and no severe reactions happened.

CONCLUSION:

90 μg BCQB per nostril four times daily is effective and safe in the treatment of rhinorrhea as well as sneezing, nasal congestion and itching for patients with PAR.

RETROSPECTIVELY REGISTERED:

ChiCTR2000030924, 2020/3/17.

News (Medical) associated with Bencycloquidium Bromide

21 May 2024

·www.prnewswire.com

YGION Biomedical announces €15 Million Series A Financing to develop Individualized Cancer Immunotherapies

VIENNA, May 21, 2024 /PRNewswire/ -- YGION Biomedical GmbH, a company dedicated to developing individualized neoantigen-based cancer vaccines, today announced the completion of a Series A financing round of €15 million from an Austrian private trust. The proceeds will be used to further develop YGION's unique YGNITETM technology platform and advance the lead program YG-01 into preclinical and clinical development. Founded in 2022, YGION's high-profile team of experienced biotech veterans and entrepreneurs are focused on developing individualized "plug-and-play" cancer vaccines through a proprietary suite of technologies to identify, produce and target the delivery of relevant peptide neoepitopes resulting in safe, exceptionally potent, and precise targeted activation of the patient's immune system. "We are on the cusp of a breakthrough in individualized cancer treatments" said Dr. Wolfgang Fischl, Chief Executive Officer of YGION. "This financing is truly exciting for YGION as we see it as a strong validation of our unique approach, and we are grateful for the support of our investors enabling us to take a significant step towards clinical validation of our technology. With the continued demonstration of the efficacy of our approach, we are open to additional investors and collaborators interested in our ground-breaking approach." "We are confident that with our technology, we can realize the promise of simple, safe and effective cancer vaccines" added Dr. Geert Mudde, Chief Technology Officer of YGION. "Our YGNITETM platform gives us the unique ability to identify, select and synthesise relevant neoantigens, and combined with our CARGONAUTTM immune-modulating carrier induces a powerful cell-mediated tumor specific response that targets and eliminates malignant cells with unmatched safety." YGION's lead program YG-01 is currently in preclinical development. About YGION Biomedical YGION Biomedical is a private preclinical stage biopharmaceutical company located in Vienna, Austria committed to realizing individualized immunotherapies against cancer. YGION's YGNITE™ platform combines next generation sequencing, bioinformatics and the proprietary CARGONAUT™ vaccine platform to deliver neoepitope peptide vaccines tailored for each tumor and each patient. For more information, visit Contact Sophie Zettl Ph.D. Chief Business Officer, YGION Biomedical GmbH [email protected] +43 660 573 1746 Logo -

VaccineImmunotherapy

100 Deals associated with Bencycloquidium Bromide

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Rhinitis, Allergic	CN	Silver Valley Pharmaceutical Co. Ltd.	17 Mar 2020

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Common Cold	Phase 3	CN	Silver Valley Pharmaceutical Co. Ltd.	28 Sep 2021
Nasal Obstruction	Phase 3	CN	Silver Valley Pharmaceutical Co. Ltd.	28 Sep 2021
Sneezing	Phase 3	CN	Silver Valley Pharmaceutical Co. Ltd.	28 Sep 2021
Rhinitis, Allergic, Perennial	Phase 1	CN	Beijing Jiahe Cachet Pharmaceutical Logistics Co. Ltd.	12 Aug 2016
Pulmonary Disease, Chronic Obstructive	Phase 1	CN	Silver Valley Pharmaceutical Co. Ltd.	09 Sep 2015
Pulmonary Disease, Chronic Obstructive	Phase 1	CN	Shanghai Institute of Pharmaceutical Industry	09 Sep 2015
Pulmonary Disease, Chronic Obstructive	Phase 1	CN	Beijing Jiashi Lianbo Medicine Technology Co., Ltd.	09 Sep 2015

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