Thyroid eye disease (TED) therapy Tepezza – the top asset in Amgen's $26 billion takeover of Horizon in 2023 – could be facing competition from an easier-to-dose alternative from Sling Therapeutics.

甲状腺眼病（TED）治疗Tepezza是安进（Amgen）于2023年斥资260亿美元收购Horizon的最大资产，它可能面临来自Sling Therapeutics的更容易给药的替代品的竞争。

The Michigan, US, biotech has announced topline data from a phase 2b/3 trial of linsitinib – claimed to be the first oral therapy to pass that milestone – and is planning to start a confirmatory phase 3 trial in the coming months that could support regulatory filings.

美国密歇根州生物技术公司（Michigan，US，biotech）宣布了来自linsitinib 2b/3期临床试验的topline数据，该试验声称是第一个通过该里程碑的口服疗法，并计划在未来几个月启动一项确认性3期临床试验，以支持监管备案。

TED is a rare autoimmune disorder in which the muscles and fatty tissues behind the eye become inflamed, causing the eyes to be pushed forward and bulge outwards in a condition known as proptosis that, if severe, can become disfiguring and disabling.

TED是一种罕见的自身免疫性疾病，眼睛后面的肌肉和脂肪组织发炎，导致眼睛向前推进并向外凸出，这种情况称为眼球突出，如果严重，可能会毁容和致残。

Linsitinib is a small-molecule inhibitor of IGF-1R, taken twice daily. In the phase 2b/3 LIDS trial, more patients treated with a 150mg dose of the drug achieved a 2mm or better reduction in proptosis after 24 weeks compared to placebo, which was a statistically significant difference.

Linsitinib是IGF-1R的小分子抑制剂，每天服用两次。在2b/3期LIDS试验中，与安慰剂相比，更多接受150mg剂量药物治疗的患者在24周后达到2mm或更好的眼球突出减少，这是统计学上显着的差异。

A lower, 75mg twice-daily dose did not outperform placebo, according to the company, but both doses there was a 'favourable safety profile', including for adverse events that are associated with IGF-1R-acting drugs including hearing impairment, high blood sugar levels, and menstrual cycle changes.

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Tepezza

特佩扎

(teprotumumab) became the first FDA-approved treatment for TED in 2020 and is still the only drug for the disorder, which otherwise needs to be treated with surgery. It is already a blockbuster, with sales reaching more than $1.3 billion in the first nine months of 2024.

。它已经是一部大片，2024年前9个月销售额超过13亿美元。

The drug is currently given once every three weeks for a total of eight infusions, so an oral alternative could be an attractive proposition for patients and healthcare systems if it reaches the market.

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Amgen isn't resting on its laurels, though, particularly with other potential rivals circling such as Viridian Therapeutics and its anti-IGF-1R antibody

veligrotug

军事列车

that needs five infusions and has cleared a phase 3 trial.

这需要五次输注，并且已经通过了第三阶段试验。

It is developing a new formulation of Tepezza that could be dosed subcutaneously every two weeks, doing away with the need for visits to an infusion clinic, although Viridian is also working on an injectable antibody that it believes could be given every four to eight weeks.

它正在开发一种新的替哌扎制剂，可以每两周皮下注射一次，不再需要去输液诊所就诊，尽管Viridian也在研究一种注射抗体，它认为可以每四到八周注射一次。

'Patients must currently choose between an invasive orbital surgery or eight infusions over 24 weeks, which can be inconvenient and time-consuming and pose serious potential risks,' said Raymond Douglas, a professor at Cedars-Sinai Medical Center who also serves as Sling's chief scientific officer.

Cedars-Sinai医学中心教授雷蒙德·道格拉斯（RaymondDouglas）说，患者目前必须在侵入性眼眶手术或24周内输注8次之间进行选择，这可能既不方便又耗时，并构成严重的潜在风险，他也是Sling的首席科学官。

'As a practising physician, it makes sense to start a new patient's treatment journey with an oral therapy that shows an early response that increases over time,' he added.

他补充说：“作为一名执业医生，通过口服疗法开始新患者的治疗旅程是有道理的，这种疗法显示出随着时间的推移而增加的早期反应。”。

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Elsa Olofsson

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