BOSTON--(BUSINESS WIRE)--Quolet, a private clinical stage biopharmaceutical company, is announcing the completion of a Phase 1 healthy volunteer study evaluating pure Cannabidiol (CBD) (clinicaltrials.gov NCT05032807). CBD is approved for treatment-resistant epilepsy in children, and recent trials suggest that it may be useful for treating other disorders, such as schizophrenia and anxiety.

波士顿--（商业新闻短讯）--私人临床阶段生物制药公司Quolet宣布完成一项评估纯大麻二酚（CBD）的第一阶段健康志愿者研究（clinicaltrials.gov NCT05032807）。CBD被批准用于儿童难治性癫痫，最近的试验表明它可能对治疗其他疾病有用，如精神分裂症和焦虑症。

However, oral CBD has relatively poor bioavailability. Researchers at King’s College London partnered with the SEEK group to test whether its bioavailability could be improved by administering CBD in a novel patented lipid formulation. This lipid formulation allows high doses of CBD (200mg) to be administered in capsules including only GRAS and/or pharmaceutical approved ingredients..

然而，口服CBD的生物利用度相对较差。伦敦国王学院（King's College London）的研究人员与SEEK小组合作，测试是否可以通过在一种新型专利脂质制剂中使用CBD来提高其生物利用度。这种脂质制剂允许高剂量的CBD（200mg）以胶囊形式给药，仅包括GRAS和/或药物批准的成分。。

In a Phase I clinical trial, fourteen healthy volunteers were given a single dose of 1000mg CBD (5 capsules of 200mg each) in two separate visits. In one visit they were given the lipid-CBD, and in the other visit they were given standard CBD-only formulation. For both visits blood levels of CBD and its metabolites were measured at regular intervals, and side effects and blood markers of liver function were monitored..

在一项I期临床试验中，14名健康志愿者在两次单独访视中接受了单剂量1000mg CBD（每粒200mg 5粒胶囊）。在一次访问中，他们服用了脂质CBD，在另一次访问中，他们服用了标准的CBD制剂。对于这两次访问，定期测量CBD及其代谢物的血液水平，并监测副作用和肝功能的血液标志物。。

Lipid-CBD achieved an AUC exposure in the blood nine times higher than the standard CBD-only formulation (611 ng·h/mL vs. 67 ng·h/mL) with statistical significance of p < 0.001. The maximum concentration (Cmax) achieved for the lipid-CBD was 24 times higher than the standard CBD-only formulation (73.0 ng/ml vs.

脂质CBD在血液中的AUC暴露量是仅标准CBD制剂（611 ng·h/mL vs.67 ng·h/mL）的9倍，具有统计学意义（p＜0.001）。脂质CBD达到的最大浓度（Cmax）比仅标准CBD制剂高24倍（73.0 ng/ml vs。

3.1 ng/ml) also clear statistical significance of p < 0.001. The time course of CBD and the metabolite levels in the blood indicated that there was minimal first-pass liver metabolism of lipid-CBD..

3.1 ng/ml）也有明显的统计学意义（p＜0.001）。CBD的时间过程和血液中的代谢物水平表明，脂质CBD的首过肝代谢最小。。

CBD at higher doses has been proven to cause adverse events such as liver toxicity. The blood levels of lipid-CBD and its metabolites has promise in the areas of side effects management and the costs to health economies.

高剂量的CBD已被证明会引起肝毒性等不良事件。脂质CBD及其代谢物的血液水平在副作用管理和健康经济成本方面具有前景。

The novel formulation used is naturally derived, UK MHRA registered EU GMP CBD API with a DMF package, manufactured by Brains Bioceutical Corp., which had been purified to such an extent that THC and its metabolites were not detectable in the product or in any of the blood analyses. This feature may be of great interest to researchers and clinicians in jurisdictions where cannabinoid medications are highly regulated..

使用的新配方是天然衍生的，英国MHRA注册的EU GMP CBD API，带有DMF包装，由Brains Bioceutical Corp.制造，已纯化至产品或任何血液分析中均未检测到THC及其代谢物的程度。大麻素药物受到高度监管的司法管辖区的研究人员和临床医生可能对这一功能非常感兴趣。。

A parallel study was conducted in rodents by the same KCL team to understand the impact of the lipid formulation on the tissue distribution of CBD. This showed that the lipid formulation was associated with a greater distribution of CBD to the brain, lung, lymphatic and adipose tissue than the regular CBD..

同一KCL团队在啮齿动物中进行了一项平行研究，以了解脂质制剂对CBD组织分布的影响。这表明脂质制剂与CBD在脑，肺，淋巴和脂肪组织中的分布比常规CBD更大。。

The Centre for Innovative Therapeutics (C-FIT) led the collaboration for KCL. KCL and SEEK Group are now collaborating on the further development of lipid-CBD. Quolet has been appointed as the commercialisation partner for SEEK.

创新治疗中心（C-FIT）领导了KCL的合作。KCL和SEEK集团目前正在合作进一步开发脂质CBD。Quolet已被任命为SEEK的商业化合作伙伴。

Role of parties:

各方的作用：

The human and animal studies were funded by an academic research grant at KCL. BTT Life Sciences, a joint venture between Brains Bioceutical Corp. and Tamar Technologies Ltd, provided the pure Brains Bio CBD API and funded the manufacture of the plain and lipid capsules used in this study.

人类和动物研究由KCL的学术研究资助。BTT Life Sciences是Brains Bioceutical Corp.和Tamar Technologies Ltd.之间的合资企业，提供了pure Brains Bio CBD API，并资助了本研究中使用的普通胶囊和脂质胶囊的制造。

Quotes:

引用：

Professor Philip McGuire, KCL PI (currently at University of Oxford): “CBD is a very promising candidate novel treatment. However, only a small proportion of oral CBD is absorbed. Our results indicate that this issue can be addressed by administering CBD in a lipid formulation. Moreover, this approach appears to increase absorption of CBD via the lymphatic system, which may reduce first pass liver metabolism and the risk of hepatic and gastro-intestinal side effects.”.

Philip McGuire教授，KCL PI（现任牛津大学）时间：“CBD是一种非常有前景的候选新型治疗方法。然而，口服CBD只有一小部分被吸收。我们的研究结果表明，可以通过在脂质制剂中服用CBD来解决这个问题。此外，这种方法似乎可以增加CBD通过淋巴系统的吸收，这可能会降低首过肝脏代谢以及肝脏和胃肠道副作用的风险cts。”。

Professor Mitul Mehta, Co-I and Director of C-FIT: “This collaboration demonstrates how our experts can work with SMEs to develop solutions to existing challenges. The potential here is to have a version of CBD which can be easily given in high doses and get to the right organs at the right levels for efficacy.

Mitul Mehta教授，Co-I和C-FIT主任：“这项合作展示了我们的专家如何与中小企业合作，开发解决现有挑战的方案。这里的潜力是有一种CBD版本，可以很容易地以高剂量给药，并以正确的水平到达正确的器官以获得疗效。

This could be a very important step in developing CBD therapeutics and we are delighted to be here at the beginning.”.

这可能是开发CBD治疗学的一个非常重要的步骤，我们很高兴从一开始就来到这里。”。

About Quolet Industries

关于Quolet Industries

Quolet Industries is a global biotech startup focused primarily on addressing a unique market need for high-dose cannabidiol (CBD), drug products which minimize liver toxicity. The fast-growing medicinal cannabis industry has been inherently limited to low-dose formulation of CBD. Researching and investigating new treatments for patients that can benefit from CBD..

Quolet Industries是一家全球生物技术初创公司，主要致力于解决高剂量大麻二酚（CBD）的独特市场需求，大麻二酚是一种可最大程度降低肝毒性的药物产品。快速增长的药用大麻行业本质上仅限于CBD的低剂量制剂。研究和调查可以从CBD中受益的患者的新疗法。。