AUCKLAND, New Zealand, June 24, 2024 /PRNewswire/ -- Douglas Pharmaceuticals New Zealand's largest pharmaceutical company, is pleased to announce that results from their recent trial, 'Randomised Placebo-Controlled Phase 2 Study of Extended-Release Ketamine Tablets (R-107) for Treatment-Resistant Depression', also known as the BEDROC study, have just been published by the leading scientific journal Nature Medicine. .

新西兰奥克兰，2024年6月24日/PRNewswire/--道格拉斯制药（Douglas Pharmaceuticals）新西兰最大的制药公司很高兴地宣布，他们最近的试验结果，“缓释氯胺酮片（R-107）治疗耐药性抑郁症的随机安慰剂对照2期研究”，也称为BEDROC研究，刚刚由领先的科学期刊Nature Medicine发表。。

Douglas Pharmaceuticals' Chief Scientific Officer, Dr Peter Surman, commented, 'We're pleased that the quality and design of the study, as well as the significance of the findings have been recognised and are now being shared with industry peers. Should R-107 perform in Phase 3 studies as in the BEDROC study this would be a life-changing medication for many individuals who suffer from Treatment-Resistant Depression (TRD), and one that could be taken safely at-home.'.

道格拉斯制药公司（Douglas Pharmaceuticals）首席科学官彼得·苏尔曼（Peter Surman）博士评论道：“我们很高兴这项研究的质量和设计以及研究结果的重要性得到了认可，现在正在与业界同行分享。如果R-107在BEDROC研究中进行3期研究，这将是许多患有难治性抑郁症（TRD）的个体的改变生活的药物，并且可以在家中安全服用。”。

The BEDROC study enrolled patients with TRD who had failed two or more antidepressants in the current period of depression. Patients responded rapidly to R-107 during the daily dose induction phase of BEDROC and around 73% (168/231) of patients were responders after 1 week. This response rate is comparable to results achieved with off-label IV ketamine treated TRD patients but without undesirable dissociation (spacing out).

。在BEDROC的每日剂量诱导阶段，患者对R-107反应迅速，约73%（168/231）的患者在1周后有反应。该反应率与使用非标签IV氯胺酮治疗的TRD患者获得的结果相当，但没有不良的解离（间隔）。

R-107 shows promise to be a rapid acting, convenient and accessible form of ketamine..

R-107有望成为一种快速，方便和易获得的氯胺酮形式。。

Dr Surman acknowledged the valuable contributions made by Douglas' Product Development Team, the investigators involved, and Professor Paul Glue, MD, University of Otago, Hazel Buckland Professor, Chair of the Trial Steering Committee for BEDROC. Professor Glue has worked closely with Douglas as a consultant and serves as the Clinical Advisory Board Chair for R-107.

Surman博士感谢道格拉斯的产品开发团队、相关研究人员以及奥塔哥大学医学博士PaulGlue教授、贝德罗克试验指导委员会主席HazelBuckland教授所做出的宝贵贡献。Glue教授作为顾问与道格拉斯密切合作，并担任R-107的临床顾问委员会主席。

With over 20 years of pharmaceutical experience, Professor Glue specialises in mood disorder research, including the use of ketamine for TRD..

Glue教授拥有20多年的药学经验，专门研究情绪障碍，包括氯胺酮用于TRD。。

Professor Glue commented, 'The BEDROC study shows that it is possible to achieve a robust anti-depressant response from ketamine without significant dissociation. We saw a clear dose response effect over 3 months and met the primary efficacy endpoint at Day 92 with significant separation from placebo in the 180 mg dose arm.

Glue教授评论道：“BEDROC的研究表明，氯胺酮有可能在没有明显解离的情况下产生强大的抗抑郁反应。我们在3个月内看到了明显的剂量反应效应，并在第92天达到了主要疗效终点，在180 mg剂量组中与安慰剂显着分离。

This gives us confidence to proceed to pivotal registrational clinical studies.'.

这使我们有信心进行关键的注册临床研究。”。

The results of the BEDROC study revealed that R-107 was well tolerated, and this was confirmed by the follow-up 6 months open-label study BEDROC-1. Most adverse events (AEs) were mild with no safety signals encountered. Dissociation and sedation AEs when administering ketamine or esketamine (one of the active components of ketamine) from rapid releasing dosage forms such as intranasal esketamine (56, 84 mg) are so significant that the product must be administered in a clinic with an observation period of at least 90 minutes after dosing.

BEDROC研究的结果显示R-107耐受性良好，随访6个月的开放标签研究BEDROC-1证实了这一点。大多数不良事件（AE）是轻微的，没有遇到安全信号。当从快速释放剂型如鼻内艾司氯胺酮（56,84 mg）中给予氯胺酮或艾司氯胺酮（氯胺酮的活性成分之一）时，解离和镇静AE非常重要，因此必须在临床上给予该产品，观察期为给药后至少90分钟。

In the BEDROC study, dissociation and sedation AEs were mild and patients took R-107 at home without any safety issues..

。。

Upon completing up to 9 months of treatment on R-107 in BEDROC and BEDROC-1 a significant portion of patients (106) were enrolled in a compassionate use program where the mean duration of treatment is currently 2 years. Most patients have continued to be treated with 180 mg of R-107 twice a week.

在BEDROC和BEDROC-1的R-107上完成长达9个月的治疗后，相当一部分患者（106名）参加了同情使用计划，目前平均治疗时间为2年。大多数患者每周两次继续接受180 mg R-107治疗。

The peer-reviewed full manuscript can be accessed here: https://www.nature.com/articles/s41591-024-03063-x

同行评审的完整手稿可以在这里访问：https://www.nature.com/articles/s41591-024-03063-x

For further information, please contact:

欲了解更多信息，请联系：

Lisa Craigie

丽莎·克雷吉

Chief Legal & Commercial Officer

首席法律和商务官

Douglas Pharmaceuticals

道格拉斯制药公司

Email: lisac@douglas.co.nz

电子邮件：lisac@douglas.co.nz

About Treatment Resistant Depression

关于难治性抑郁症

About 60 million patients in the United States and Europe suffer from Major Depressive Disorder (MDD).  Roughly one third of MDD patients are classified as being treatment resistant, in that they have failed two or more antidepressants in the current period of depression.

美国和欧洲约有6000万患者患有重度抑郁症（MDD）。大约三分之一的MDD患者被归类为抗药性，因为他们在目前的抑郁症期间服用了两种或多种抗抑郁药。

About R-107

关于R-107

R-107 is a proprietary, extended-release oral dose of ketamine developed for the treatment of patients with TRD.  After administration the active ingredient ketamine is released at a slow, steady rate. The reduction in dissociative side effects is attributed to a low systemic concentration of ketamine.

R-107是一种专有的缓释口服剂量的氯胺酮，用于治疗TRD患者。给药后，活性成分氯胺酮以缓慢稳定的速度释放。解离副作用的减少归因于氯胺酮的全身浓度低。

An IND is open with the US FDA for all studies needed to support a regulatory submission. Douglas is open to meeting potential partners and investors interested in collaborating to complete the Phase 3 development of R-107 and prepare it for commercialisation..

IND向美国FDA开放所有支持监管提交所需的研究。道格拉斯愿意与有兴趣合作完成R-107第三阶段开发并为商业化做好准备的潜在合作伙伴和投资者会面。。

For more information, please visit: A world-first at home treatment for Treatment Resistant Depression - R-107 on Vimeo

有关更多信息，请访问：世界上第一个治疗难治性抑郁症的家庭治疗-Vimeo上的R-107

About Douglas Pharmaceuticals

关于道格拉斯制药

Douglas Pharmaceuticals is a privately held pharmaceutical company headquartered in Auckland, New Zealand.  Douglas Pharmaceuticals is a developer and manufacturer of generic and repurposed medicines sold in the US, Europe and in over 40 markets globally. The Douglas mission is to 'Improve Lives' by providing innovative, competitive, and high-quality healthcare solutions.

道格拉斯制药公司是一家私营制药公司，总部位于新西兰奥克兰。道格拉斯制药（Douglas Pharmaceuticals）是仿制药和再利用药物的开发商和制造商，在美国、欧洲和全球40多个市场销售。道格拉斯的使命是通过提供创新、有竞争力和高质量的医疗保健解决方案来“改善生活”。

Douglas' core business is producing prescription drugs for areas including oncology, dermatology, the central nervous system, and immunology. Douglas develops, manufactures, and distributes novel and generic products, with a preference for those where there is a strong intellectual property position as well as technical complexity in areas of high unmet need. .

道格拉斯的核心业务是为肿瘤学、皮肤病学、中枢神经系统和免疫学等领域生产处方药。道格拉斯开发、制造和分销新颖和通用产品，优先选择那些在未满足需求的领域具有强大知识产权地位和技术复杂性的产品。。

For more information, please visit: www.douglas.co.nz

有关更多信息，请访问：www.douglas.co.nz

About Nature Medicine

关于自然医学

Nature Medicine is a world-leading, peer-reviewed scientific journal that covers all aspects of research related to medicine. The journal has a 2022 2-year impact factor of 82.9.

《自然医学》是一本世界领先的同行评审科学期刊，涵盖了与医学相关的研究的各个方面。《华尔街日报》2022年2年的影响因子为82.9。

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SOURCE Douglas Pharmaceuticals Ltd

来源：道格拉斯制药有限公司