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

Dia Beta Labs(DBL)是一家**北爱尔兰的生物技术公司**，致力于应对由肥胖和糖尿病流行不受控制而导致的席卷全球的日益恶化的代谢性疾病危机。DBL在代谢性疾病中发现了一种**新的疾病靶点**，该靶点被我们目前的先导分子DBL002有效地利用了。我们迄今的数据表明，我们的先导分子DBL002具有**改变患者预后的潜力，超越了目前的护理标准**。特别是，我们发现使用它**比减少肌肉**更有利于脂肪减少**，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多地处置血糖而间接发生的。这些效应是因为我们的新的、以前未被开发的感兴趣的受体在多种代谢组织中表达，例如大脑的食欲调节中心、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。与目前不区分肌肉或脂肪损失的现有药物相比，DBL002的效果**改善了减肥的质量**。除了对肌肉损失的担忧外，目前可用的抗肥胖药物，即GLP-1类似物，通常会导致严重的胃肠道副作用，最终导致**70%的患者在24个月内停止使用这些疗法**。**目前没有合适的替代疗法**。因此，对肥胖管理的新的有效和耐受性良好的疗法**有相当大的需求。这个项目**建立在我们成功验证我们的新目标**的基础上，并通过开发DBL002有效地利用它，DBL002是我们目前的领先产品。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相当大的兴趣，但我们的**数据到目前为止只专注于对雄性啮齿动物的影响**。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差异增加，这一点现在得到了国家研究中动物替换、改进和减少中心(NC3Rs)的承认。因此，我们现在试图确认我们**令人兴奋的抗肥胖效果**在女性身上保持**，并试图先发制人，在发展的早期阶段进行性别平衡研究。这进一步验证了我们到目前为止令人兴奋的发现，我**改善了一流的代谢性疾病治疗药物的商业化潜力。DBL将利用我们与Pharma的现有关系，如礼来公司和诺和诺德公司，为实验设计提供信息，并在整个项目中帮助商业化战略。

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.