Confirmation of therapeutic benefit of a novel metabolic disease treatment in female subjects

证实一种新型代谢性疾病治疗方法对女性受试者的治疗效果

• 批准号: 10104244
• 金额: $ 12.63万
• 依托单位: DIA BETA LABS
• 依托单位国家: 英国
• 项目类别: Launchpad
• 财政年份: 2024
• 资助国家: 英国
• 起止时间: 2024 至 无数据
• 项目状态: 未结题
• 来源: https://gtr.ukri.org/projects?ref=10104244
• 关键词: Confirmation; therapeutic; benefit; novel; metabolic

Dia Beta Labs (DBL) is a **Northern-Ireland based biotech company** committed to tackling the worsening metabolic disease crisis sweeping the globe, driven by uncurbed prevalence of obesity and diabetes. DBL has uncovered a **novel disease target** in metabolic disease which is effectively exploited by our current lead molecule, DBL002\.Our data to date indicates our lead molecule DBL002 has the potential to **transform patient outcomes over current standards of care**. In particular, we have found its use **favours fat loss over muscle loss**, a major advantage. This occurs through direct actions on brown fat and indirectly through reduction of appetite and greater disposal of blood glucose. These effects are because our novel, previously unexploited receptor of interest, is expressed in multiple metabolic tissues such as appetite-regulating hypothalamic centres of the brain, insulin-producing beta-cells of the pancreas, gut motility-regulating cells of the intestine and within fat itself. The effects of DBL002 **improve the quality of weight loss obtained compared to currently available agents** which do not discriminate between muscle or fat loss.In addition to the concern around muscle loss, currently available anti-obesity medications, namely GLP-1 analogues, cause often severe gastrointestinal side-effects, culminating in **discontinuation of these therapeutics in 70% of patients by 24-months**. **No suitable alternative treatment exists presently**. Thus, there is **considerable need** for new effective and well tolerated therapeutics for obesity management.This project **builds upon our success in validating our novel target**, and its effective exploitation through development of DBL002, our current lead. Whilst we have built a strong commercial data package, which has been of considerable interest to potential Pharma partners, our **data to date has focused on effects in male rodents only**. Indeed, a common flaw in preclinical research at present is the favoured use of male animals, owing to a perceived increase of variance in female animals, which is now recognised by the National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs).Thus, we now seek to confirm that our **exciting anti-obesity effects are maintained in females** and seek to pre-empt the requirement for gender-balanced studies at earlier stages of development. This further validates our exciting findings to date and i**mproves commercialisation potential for a first-in-class agent for metabolic disease** management. DBL will leverage our existing relationships with Pharma, such as Eli Lilly and Novo Nordisk, to inform experimental design and to aid commercialisation strategies throughout this project.

Dia Beta Labs（DBL）是一家位于爱尔兰北部的生物技术公司，致力于解决由肥胖和糖尿病的无节制流行所导致的席卷地球仪的日益恶化的代谢疾病危机。DBL在代谢性疾病中发现了一个 ** 新的疾病靶点 **，我们目前的先导分子DBL 002\有效地利用了这一靶点。迄今为止，我们的数据表明，我们的先导分子DBL 002有可能 ** 改变患者的治疗结果，超过目前的治疗标准 **。特别是，我们发现它的使用 ** 有利于脂肪损失超过肌肉损失 **，这是一个主要的优势。这是通过对棕色脂肪的直接作用和通过减少食欲和更大程度地处理血糖间接发生的。这些效应是因为我们的新的，以前未开发的感兴趣的受体，在多种代谢组织中表达，如大脑的食欲调节下丘脑中心，胰腺的胰岛素产生β细胞，肠道的肠道运动调节细胞和脂肪本身。DBL 002 ** 的效果与目前可用的药物 ** 相比改善了所获得的体重减轻的质量，目前可用的药物不区分肌肉或脂肪的减少。除了肌肉减少的问题之外，目前可用的抗肥胖药物，即GLP-1类似物，通常会引起严重的胃肠道副作用，最终导致70%的患者在24个月时 ** 停止这些治疗。** 目前没有合适的替代治疗方法 **。因此，有 ** 相当大的需求 ** 为新的有效和良好的耐受性治疗肥胖管理。这个项目 ** 建立在我们的成功验证我们的新目标 **，并通过开发DBL 002，我们目前的领导有效利用。虽然我们已经建立了一个强大的商业数据包，这已经引起了潜在的制药合作伙伴的极大兴趣，但迄今为止，我们的 ** 数据仅集中在雄性啮齿动物中的影响 **。事实上，目前临床前研究中的一个常见缺陷是倾向于使用雄性动物，这是由于雌性动物的变异增加，这一点现在被国家研究动物替代、改进和减少中心（NC 3R）所认识到。我们现在试图确认我们的 ** 令人兴奋的抗肥胖效果在女性中保持 **，并试图预先取代性别要求-在发展的早期阶段进行平衡研究。这进一步验证了我们迄今为止令人兴奋的发现，并提高了代谢疾病管理一流药物的商业化潜力。DBL将利用我们与礼来和诺和诺德等制药公司的现有关系，为整个项目的实验设计提供信息，并帮助制定商业化战略。