Fexolazan hydrochloride

Neurogastrx believes its drug could treat one of the most troublesome side effects of one of the industry’s biggest blockbusters. On Wednesday, the Boston-area biotech said that its experimental drug, NG101, reduced the incidence of nausea by 40% and cut vomiting by 56% in adults taking Novo Nordisk’s semaglutide, which is marketed as Wegovy for obesity and Ozempic for type 2 diabetes. In the Phase 2 trial, about 90 adults received a single subcutaneous dose of semaglutide, at 0.5 mg, and then for five days, they took two capsules of NG101 or placebo each day. The results were statistically significant. Neurogastrx sees a market opportunity worth “billions of dollars,” CEO James O’Mara told Endpoints News. “The GLP-1s are miracle drugs,” O’Mara said. But many patients stop taking the medicines within a year, and a lot of them cite the gastrointestinal side effects as a key reason, he said. The news is Neurogastrx’s first major step since 2021, when it outlined a $60 million Series B and unveiled a partnership with Daewoong Pharmaceutical, which it then terminated in mid-2023. NG101 is a dopamine D2 antagonist, and it affects the area postrema, or the “nausea center of the brain,” O’Mara said. That region is outside the blood-brain barrier, meaning it might allow the medicine to avoid CNS side effects that come with some other dopamine modulators, the CEO said. Neurogastrx will have to test NG101 in larger studies and for a longer duration before seeking regulatory approval, and the company aims to start either a Phase 2 or a Phase 2/3 trial next year, the CEO said. “Whether it’s registrational, we’ll have to see,” O’Mara said. A Phase 3 would likely involve both semaglutide and Eli Lilly’s related drug tirzepatide. “I think you would have to include both eventually in order to get them in the label,” O’Mara said. The company thinks it can raise the money it needs to get into later-stage testing, O’Mara said, noting Neurogastrx is starting discussions with potential partners and funding sources. In February 2023, Neurogastrx completed a Phase 2 of NG101 in patients with gastroparesis, in which the body struggles to empty food, but the company has yet to announce the results. O’Mara said the results have been submitted for publication and described the data as “interesting.” “We had endpoints which looked good and others which we were disappointed in,” he said. In May, another biotech in the space, CinDome Pharma, announced a $40 million funding extension to finish its Phase 2 in diabetic gastroparesis. It anticipates results next year and will likely seek a pharma partner or acquirer to bring it into Phase 3, CinDome creator CinRx CEO Jon Isaacsohn told Endpoints in May . O’Mara also gave more details of the company’s terminated pact with South Korea’s Daewoong. Under the deal, Neurogastrx was to have developed Daewoong’s investigational acid blocker fexuprazan for GERD and other acid-related conditions. The US and Canada-focused agreement was terminated last year. “We did a deal for fexuprazan when there was a lot of money flowing into biotech, and very shortly, frankly, after we closed that deal, it was just harder to raise capital,” O’Mara said. “We wanted to be fair with our collaborator and give them the opportunity to find another company that could better escort the drug forward.”

包括全球首款微针疗法以及每月使用一次的肥胖症疗法 米兰 2024年10月11日 /美通社/ -- Daewoong Pharmaceutical（大熊制药）（联席首席执行官Seongsoo Park和Chang-jae Lee）于10月9日宣布，他们将在意大利米兰的全球最大制药与生物技术展"2024年世界制药原料展"(CPHI Worldwide 2024)上展示其尖端给药技术，包括全球首款微针疗法药物。此外，Daewoong还将继续扩大其创新新药Fexuprazan（非苏拉赞）和Enavogliflozin（依那格列净）的全球影响力。 Daewoong曾参展了2023年在巴塞罗那举办的CPHI，连续第二年展示了其创新药物开发的成果。在今年的米兰CPHI上，Daewoong的目标是通过扩大全球影响力和发布新的给药技术来实现其"一个产品，一万亿韩元"(One Product, One Trillion Won )的愿景。 微针技术是Daewoong创新技术中的佼佼者，有望彻底改变给药系统。 虽然传统的注射药物能可靠地将药物输送到体内，但它们往往伴随着疼痛，而且需要到医院就诊。相比之下，由微小针头组成的微针消除了人们对注射的恐惧，减少了去医院就诊的需要，大大改善了病人的依从性。尽管许多公司都在研究微针药物，但至今尚未有成功将其商业化的案例。迄今为止，可用的微针产品仅限于美容贴片。 Daewoong的子公司Daewoong Therapeutics开发了一种名为"CLOPAM ® "的创新微针平台，它通过空气动力学工艺和密封包装提高了药物的均匀性和稳定性。该平台克服了以往微针技术中存在的污染和药物不一致性问题。 CLOPAM ® 微针贴片面积为1平方厘米，内含约100根微针，一经皮肤穿透即溶解释放药物。CLOPAM ® 已获得六项国际专利申请和23项国内专利（其中五项已注册），被视为Daewoong未来的一项关键技术。 此外，Daewoong Therapeutics最近还获得了韩国食品药品安全部(Ministry of Food and Drug Safety)的批准，可以进行人体生长激素微针贴片的一期临床试验，这也是韩国首例可溶解微针。该公司还在积极开发使用索马鲁肽(Semaglutide)治疗糖尿病和肥胖症的微针疗法，以及使用肉毒杆菌毒素治疗神经系统疾病的微针疗法。 除了微针技术外，Daewoong还将展示用于治疗肥胖症的长效索马鲁肽注射剂。这种每月注射一次的注射剂可缓慢释放索马鲁肽，治疗剂量能维持30天。此方法弥补了当前市场的一大空白，因为现有的肥胖治疗方法往往需要每天或每周注射。Daewoong正在开发的微针贴片和每月一次的注射剂有望超越竞争对手，为患者提供一种痛苦更小、更为便捷的治疗方案。 Daewoong还将推出一款新型的、便于患者使用的结肠镜检查肠道准备药物(DWRX1010)。传统的结肠镜检查准备药物通常味道不佳，需要饮用大量水，或需要吞服大药丸，这不仅给患者带来不适，有时甚至让患者不愿接受检查。大熊制药新研发的小型片剂易于吞服，为准备接受结肠镜检查的患者提供了更为便捷的解决方案。 Daewoong全球业务中心负责人Doyoung Kim表示："这是我们第十年参加CPHI展会，如今市场不仅需要原材料和成品，还需要满足消费者需求的技术。随着每年的发展，Daewoong在全球的地位不断提升，尤其是在新药和技术推出方面。我们致力于通过创新的给药技术，培育畅销产品，在Fexuprazan和Enavogliflozin取得成功的基础上，进一步巩固我们在全球医疗市场的领先地位。"