Wall Street is buzzing about Gilead’s new rheumatoid arthritis drug. Here’s why

风湿关节炎药物3期临床试验达到主要终点, Galapagos 股价飙升25%

2019-04-02 08:00:00 MarketWatch

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Shares of Belgium-based biotech Galapagos NV soared 25% Friday after the company, together with pharmaceutical giant Gilead Sciences Inc., announced that two Phase 3 trials of their investigational rheumatoid arthritis drug had achieved their primary endpoints. But what really had Wall Street excited was the drug’s safety profile. Filgotinib is an oral, selective JAK inhibitor, a class of drug that has been dogged by safety concerns. JAK inhibitors, including Eli Lilly & Co’s LLY, +0.42%   Olumiant and Pfizer Inc.’s PFE, +0.38% Xeljanz, can have serious side effects, including an increased risk for serious infections, malignancies, and in Olumiant’s case, for cardiovascular events like deep vein thromboses and pulmonary embolisms. But filgotinib, which Galapagos GLPG, +24.53%  is developing with Gilead GILD, +2.79% showed promising safety data, while demonstrating similar effectiveness to competitors. Gilead shares rallied 2.8% in afternoon trade. Galapagos’ U.S.-listed shares were on track to close at the highest level since September 2018. Read: Prescription drug prices aren’t rising — they’re falling for the first time in 47 years Also: Shoppers want Amazon-brand prescription drugs, medical marijuana and cryptocurrency “FINCH 1 & 3 confirm filgotinib’s best-in-class safety profile,” analysts at J.P. Morgan wrote in a note Friday, referring to the two trials by name. In one trial, researchers looked at filgotinib alone and in combination with methotrexate, a mainstay treatment, in patients who had never been treated with methotrexate before. After 24 weeks, a greater proportion of patients on the combination therapy showed a greater than 20% improvement in the number of tender and swollen joints (a measure called ACR20, which was the trial’s primary endpoint) than those on methotrexate alone. In another trial, researchers looked at how two different doses of filgotinib held up against AbbVie Inc.’s ABBV, +0.83% top-selling Humira or methotrexate. This time, patients enrolled in the trial were already being treated with methotrexate, but had not responded adequately to the drug. After 12 weeks, the proportion of patients who got to ACR20 was higher in the filgotinib group than in the methotrexate group. However, by most measures, patients on filgotinib did not show statistically significant improvement compared with those on with Humira. The exception: A greater proportion of patients on filgotinib achieved clinical remission than those on Humira. What really caught Wall Street’s eye was filgotinib’s safety data. Data from three Phase 3 studies showed that among patients who were already receiving methotrexate, 1.5% of those who were given the higher dose of filgotinib had serious infections as a side effect, compared with 2.5% of those given Humira. And none of the patients on the higher dose of filgotinib had malignances, compared with 0.3% of those on Humira. Filgotinib's safety profile is important to investors. There are other JAK inhibitors on the market, and the Food and Drug administration is reviewing a new drug application that AbbVie submitted in December for its own JAK inhibitor called upadacitinib. It’s what could set it apart from the others. “Since filgotinib is likely to be the fourth JAKi to market, a clean safety profile could help drive use,” said analysts at Jefferies in a Friday note. Don't miss: Soaring cost of new specialty drugs the next front in war over high prescription prices Some analysts were excited about how filgotinib’s safety data compared with that of AbbVie’s upadacitinib. The Gilead and Galapagos trials did not directly compare filgotinib with upadacitinib, but analysts at J.P. Morgan said they thought filgotinib’s safety data looked stronger, especially when it came to deep vein thromboses and pulmonary embolisms. However, unlike filgotinib, upadacitinib did show better efficacy than Humira on several measures, “which could be a slight marketing disadvantage for filgotinib,” J.P. Morgan analysts wrote. Filgotinib’s trial results come at a time when Gilead, amid sliding hepatitis C drug sales, is looking for new ways to expand its business. Shares of the pharmaceutical giant have fallen 13% in the past 12 months, while the S&P 500 SPX, +0.46%  has gained 7%. Shares of Galapagos have gained 19%. Sarah Toy reports on health care for MarketWatch. You can follow her on Twitter @sarahtoy17.
比利时生物科技公司 Galapagos NV 股价上周五飙升25%,此前该公司与制药巨头吉利德科学公司( Gilead Sciences Inc .)宣布,他们研究的风湿关节炎药物的两个3期临床试验已经达到了主要终点。 但真正让华尔街兴奋的是该药物的安全状况。Figotinib 是一种口服选择性 JAK 抑制剂,一种被安全问题困扰的药物。JAK 抑制剂,包括礼来(Eli Lilly)& Co LLY ,+0.42% Oluminant 公司和辉瑞(Pfizer)公司 PFE ,+0.38% Xeljanz 可能会产生严重的副作用,包括严重感染、恶性肿瘤的风险增加,而 Olumiant 的情况是,心血管事件如深静脉血栓和肺栓塞的风险增加。 但是菲戈蒂尼,加拉帕戈斯 GLPG ,+24.53% 与吉利德(Gilead)共同发展 GILD ,+2.79% 显示了有希望的安全数据,同时证明了与竞争对手相似的有效性。 吉利德(Gilead)股价在午后交易中上涨了2.8%。加拉帕戈斯在美国上市的股票有望达到2018年9月以来的最高水平。 阅读:处方药价格没有上涨——这是47年来首次下跌 此外,购物者还需要亚马逊品牌的处方药、医用大麻和加密货币 摩根大通( J.P . Morgan )分析师在上周五的一份报告中写道:“ FINCH 1&3证实了菲戈替尼的一流安全状况。”报告中提到了两项试验的名称。 在一项试验中,研究人员单独观察了菲戈替尼,并与一种主流治疗方法甲氨蝶呤联合应用,治疗之前从未接受甲氨蝶呤治疗的患者。24周后,接受联合治疗的患者中,有更大比例的患者表现出比单独使用甲氨蝶呤的患者更多的压痛和肿胀关节(一种称为 ACR20的措施,是试验的主要终点)。 在另一项试验中,研究人员研究了两种不同剂量的丝氨酸对艾伯维(AbbVie)公司的影响 ABBV ,+0.83% 畅销悍马或甲氨蝶呤。这一次,参加试验的患者已经接受了甲氨蝶呤治疗,但对该药反应不充分。 12周后,丝裂组 ACR20的患者比例高于甲氨蝶呤组。然而,从大多数的测量来看,与 Humira 相比,丝裂霉素患者并没有表现出统计学上的显著改善。例外情况:与 Humira 相比,丝裂霉素患者获得临床缓解的比例更高。 真正吸引华尔街注意的是 filgotinib 的安全数据。三期三项研究的数据显示,在已经接受甲氨蝶呤治疗的患者中,1.5%服用丝裂霉素的患者有严重感染,而给予 Humira 的患者中只有2.5%。与 Humira 的0.3%相比,服用菲戈替尼剂量较高的患者没有发生恶性肿瘤。 Filmgotinib 的安全状况对投资者很重要。市场上还有其他 JAK 抑制剂,美国食品和药物管理局正在审查一项新的药物申请,艾伯维(AbbVie)于去年12月提交了自己的 JAK 抑制剂 upadacitinib 。这是什么可以使它与其他的区别。 杰富瑞( Jefferies )分析师在上周五的一份报告中表示:“由于丝氨酸可能是第四个推向市场的 JAKi ,清洁的安全配置可能有助于推动使用。” 不要错过:在高处方药价格的战争中,新的特殊药物的成本急剧上升 一些分析人士对 filgotinib 的安全数据与艾伯维(AbbVie)的 upadacitib 相比是如何的感到兴奋。吉利德(Gilead)和 Galapagos 的试验并没有直接比较 filgotinb 和 upadacitinib ,但摩根大通( J.P . Morgan )的分析师说,他们认为 filgotinb 的安全数据看起来更强,尤其是当涉及到深静脉血栓和肺栓塞时。 然而,与 filgotinib 不同的是, upadacitinib 在几项指标上的确比 Humira 表现得更好,“这可能对 filgotinib 构成轻微的营销劣势,”摩根大通分析师写道。 Filmgotinib 的试验结果出炉之际,在丙型肝炎药物销售下滑的背景下,吉利德(Gilead)正在寻找拓展业务的新途径。过去12个月,这家制药巨头的股价下跌了13%,而标准普尔500指数则下跌了500 SPX ,+0.46% 上涨了7%。加拉帕戈斯的股价上涨了19%。 Sarah Toy 为 MarketWatch 报道了医疗保健。你可以在 Twitter @ sarahtoy17上跟踪她。

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