字号·· | 护眼
商业内幕

历经漫长而奇特的旅程,这位CEO即将把裸盖菇素药片推向市场After a long, strange trip, this CEO is close to taking a psilocybin pill to market

点「原文对照」整页切到原文,或双击某段只看那段的原文。

2022 年,卡比尔·纳斯在一家研发抗精神病药物的制药公司担任舒适的高管职位。随后,他接到一家新兴公司的电话,该公司拥有一种合成裸盖菇素(即魔法蘑菇活性成分)的专利,计划利用该化合物帮助治疗难治性抑郁症患者。他们希望纳斯担任首席执行官。纳斯的父亲曾自杀,他在第二轮推介后接受了邀请。

In 2022, Kabir Nath had a cushy executive job at a pharmaceutical firm that developed anti-psychotic medication. Then he got a call from a scrappy upstart with a patent on a synthetic version of psilocybin — the active ingredient in magic mushrooms. It hoped to use the compound to help those with treatment-resistant depression. They wanted him to join as CEO. Nath, whose father died by suicide, bit on their second pitch.

纳斯在接受《商业内幕》采访时说:“过去几年里,有不少人对我说:‘你真的意识到这有多大风险吗?’我当时跳槽去一家尚未获得 FDA 批准的药企,这在当时以及现在都是一件事。”他补充道:“我可能是第一位真正从传统制药公司转向致幻剂领域的高级管理者,但,你知道的,这是正确的选择。”

"A number of people have said to me in the last couple of years: 'You do realize what a risk that was,'" Nath told Business Insider about eventually jumping ship for what was, and still is, a drug company without FDA approval for its product. "I was probably the first really senior executive from traditional pharma to make the move to psychedelics," he added. "But, you know, it was the right thing to do."

随着 Compass Pathways 完成最终文件的提交,可能在明年即获 FDA 批准,并随后公开推出其名为 COMP360 的裸盖菇素胶囊,纳斯个人的风险也随之放大。Compass 最近新增了 150 名员工,扩大了营销部门,并在泽西市搬入新办公空间,希望一切顺利。纳斯说:“公司正在快速增长。”

Nath's personal risk is now magnified as Compass Pathways finishes filing its final forms ahead of what could be FDA approval as soon as next year, and then a public rollout of its psilocybin pill, called COMP360. Compass has recently added 150 new hires to its payroll, expanded its marketing division, and moved into new office space in Jersey City in the hope it all works out. "The company is growing rapidly," Nath said.

虽然强生的子公司在 2019 年凭借一种用于抑郁症患者的氯胺酮版本获得了 FDA 批准,但这并不意味着采用更传统致幻剂的 Compass 必然会获得同样的批准。如果 FDA 拒绝 Compass 的申请,投资者可能会抢售其股票,导致公司破产。刚刚刷上新鲜青柠绿色油漆的泽西市办公室将变得难以维持。

Though a subsidiary of Johnson and Johnson attained FDA approval with a version of ketamine for depression patients in 2019, it is by no means guaranteed that Compass, leveraging a more traditional psychedelic, will get the same approval. Should the FDA deny Compass' bid, investors would rush to dump their shares, likely sending the company into bankruptcy. The Jersey City office, which just received a new lime green paint job, would be untenable.

如果问纳斯,这对美国 400 万抑郁症患者来说也是坏消息,因为他们对传统抗抑郁药如 SSRIs 无效。他说:“这些人一直在与抑郁症作斗争,却没有真正有效的治疗方法。”

If you ask Nath, it would also be bad news for 4 million patients with depression in the US, for whom more traditional antidepressants like SSRIs don't work. "These are people who have been suffering from depression, and nothing's really working," he said.

正如其他制药公司——尤其是那些只有一款产品的公司——Compass的股票“经历了一番大起大落”,Nath说道,随着公司推进各阶段人体试验。周五收盘时,股价徘徊在11美元左右,比去年上涨了5美元。2020年公司上市时,股价为17美元。裸盖菇素走向医学研究前沿的历程并非始于Compass,也并非一帆风顺。鲜有人能像Timothy Leary那样为这种药物造势,这位哈佛教授后来成了迷幻药的弃儿。

Like other drug companies — especially those with a single product — Compass' stock has "been on quite the adventure," Nath said, as the company progressed through various human trials. When markets closed on Friday, the share price hovered around $11, up $5 from last year. In 2020, when the company went public, shares went for $17. Psilocybin's journey to the forefront of medical research didn't begin with Compass, and it hasn't exactly gone in a straight line. Few did more to publicize the drug than Timothy Leary, the Harvard professor turned acid dropout.

据《哈佛深红报》报道,1962年他在哈佛剑桥校区的一次演讲中告诉学生,服用裸盖菇素能让人体验“内在的重生”。后来,随着他和美国相当一部分民众开始更大量地尝试迷幻药物,Leary被哈佛解雇。到1966年,感恩而死乐队在他们的饮料中掺入了LSD,一个留长发、服用迷幻药的嬉皮士亚文化群体已然形成。与此同时,研究人员也在进行实验。

In a speech at Harvard's Cambridge campus in 1962, he told students that taking psilocybin allows people to experience an "internal rebirth," according to the Harvard Crimson. In time, Leary would be fired from Harvard as he, along with a measurable portion of the US population, began to experiment more heavily with psychedelic drugs. Come 1966, the Grateful Dead were spiking their Kool-Aid with acid, and a definitive subculture of long-haired, psychedelic-taking hippies had emerged. Meanwhile, researchers were experimenting too.

涉及LSD和裸盖菇素的研究在1960年代蓬勃发展,直到1970年撞上了一堵墙,当时裸盖菇素被列为一级管制物质,持有变成非法,即便是为了研究目的也不行。该药物的研究随之停滞多年,直到2000年,FDA批准约翰霍普金斯大学的科学家开展裸盖菇素研究。最近,迷幻药在科技圈变得流行起来。从“燃人节”到奢华疗养胜地,尝试迷幻药如今在Elon Musk和Sam Altman等科技创始人和高管中很常见,他们称这些药物能平复神经、提高生产力,并让他们更好地激发创造力。

Studies involving LSD and psilocybin flourished during the 1960s before hitting a brick wall in 1970, when psilocybin was classified as a Schedule I substance, rendering possession illegal, even for research purposes. Work on the drug languished for years, until 2000, when the FDA gave scientists at Johns Hopkins University permission to conduct research on psilocybin. And more recently, psychedelics have become trendy with the tech crowd. From Burning Man to luxury retreats, experimenting with psychedelics is now common among tech founders and executives like Elon Musk and Sam Altman, who credit the drugs with quieting their nerves, boosting productivity, and allowing them to better harness their creativity.

研究也蓬勃发展。“实际上从2018年到2022年左右曾出现过一波生物技术热潮,”Nath说道。

Research, too, has flourished. "There was actually a biotech boom from 2018 through to about 2022," Nath said.

“在那次热潮中,字面意义上有数百家迷幻药公司上市。”2018年,Compass公司的专利裸盖菇素配方获得了美国食品药品监督管理局(FDA)的突破性疗法认定。几年后,该公司开始在人体上测试这种药物。2018年,Nath是日本制药巨头大冢制药的一名高管,他表示,在读了迈克尔·波伦的《如何改变你的思维》一书后,他组建了一个团队,调查迷幻药是否能成为可行的药物,该书探讨了迷幻药的历史和治疗潜力。

"In that boom, literally hundreds of psychedelic companies went public." In 2018, Compass' proprietary psilocybin formulation received breakthrough therapy designation from the FDA. A few years later, it started testing the drug on people. Nath was an executive in 2018 at Japanese pharmaceutical giant Otsuka, where he said he assembled a team to investigate whether psychedelics could become viable medicines after reading Michael Pollan's book "How to Change Your Mind," which explores the history and therapeutic potential of psychedelics.

不过,Compass并非在兜售一种类似于在“火人节”上经历精神觉醒的体验。参加Compass临床试验的患者服药流程略有不同。首先,患者必须患有难治性抑郁症,其临床定义为两种或以上标准药物治疗均失败的抑郁症。然后,临床医生会向患者解释即将进行的流程细节。之后,患者会以药丸形式服用裸盖菇素。“这是一个安静的房间,里面有一张长沙发,”Nath说。

Compass isn't selling an experience analogous to a spiritual awakening at Burning Man, though. The drug-taking process for a patient enrolled in one of Compass' trials is a bit different. First, a patient has to have treatment-resistant depression, which is clinically defined as depression that two or more standard drugs have failed to treat. Then, a clinician explains the details of the process that is about to unfold. After that, they're given the psilocybin in pill form. "It's a quiet room with a couch," Nath said.

“会给患者提供眼罩,大多数患者确实会佩戴。”当患者开始产生幻觉时,背景中会轻柔地播放一份播放列表,包括古典音乐和新世纪音乐。Nath表示,临床医生(可能是护士、医生或治疗师)会为了安全原因以及在患者想交谈时倾听,静静地坐在房间里。不过,大多数时候并没有任何交谈。“这不是心理治疗,”Nath说。

"They're offered a blindfold, which most patients do actually wear." As the patient begins to trip, a playlist of music, including classical and new age, plays softly in the background. The clinician, who Nath said could be a nurse, doctor, or therapist, sits silently in the room if the patient wants to talk, and for safety reasons. Most of the time, though, there isn't any talking. "This is not psychotherapy," Nath said.

“我们不会引导患者的体验。”六小时后,在经历了哭泣、大笑以及介于两者之间的一切情绪后,患者回家。在Compass最近一次临床试验中,其结果于9月公布,服药参与者中略低于一半的人在治疗后六周内抑郁症状至少减轻了50%。

"We are not directing the patient's experience." Six hours later, after some crying, laughing, and everything in between, the patient goes home. In Compass's most recent trial, results for which were published in September, just under half of participants who took the drug experienced at least a 50% reduction in depressive symptoms within six weeks of treatment.

经过十年的艰苦测试,先在动物身上,后在人体上,Compass已完成所有必要的前置条件,正忙着整理最后的文件。在向《商业内幕》提供的一份声明中,FDA发言人态度不置可否。“FDA通过严格、循证的流程评估实验性药物,包括像裸盖菇素这样的迷幻药物,旨在确保任何获批治疗在适应症用途上都是安全有效的,”该发言人表示。

After a decade of slogging through tests, first on animals and then on humans, Compass has completed all the necessary prerequisites and is busily working to get its last papers in order. In a statement provided to Business Insider, an FDA spokesperson was noncommittal, though. "The FDA evaluates experimental medications, including psychedelic drugs like psilocybin, through a rigorous, evidence-based process designed to ensure that any approved treatment is safe and effective for the indicated use," the spokesperson said.

Compass并非唯一一家在漫长的药物试验过程中摸索前行的迷幻药公司。另一家在纳斯达克上市、产品尚未获FDA批准的迷幻药公司AtaiBeckley,正在开发一种通过鼻喷剂给药的DMT版本。它于2025年获得突破性疗法认定,比Compass晚了数年。不过,Compass最早可能在明年上半年面临关键时刻,届时预计FDA将做出裁决。

Compass isn't the only psychedelic drug company wading through the lengthy process of trialing a drug. AtaiBeckley, another psychedelic drug company trading on the Nasdaq whose product is not yet approved by the FDA, is developing a version of DMT administered via nasal spray. It received breakthrough status in 2025, years behind Compass. For Compass, though, it could face the music as soon as the first half of next year, when it expects the FDA to render its decision.

公司已做好准备。除了新增150名员工,Nath表示,公司正准备让销售团队上线运作,并与医生和医疗服务提供者保持频繁沟通,探讨在治疗师可向患者给药的诊所开展运营事宜。“这有可能带来根本性的不同,同样,起效速度是他们非常期待的,疗效的持久性也是,”Nath指的是精神科医生。

The company is already getting ready. In addition to adding 150 new hires, Nath said the company is preparing its sales force to go online and is in frequent communication with doctors and healthcare providers about operating in clinics where therapists can administer the drug to patients. "This has the potential to be radically different, and again, the rapidity is something that they're very excited about, and the durability," Nath said, referring to psychiatrists.

阅读媒体原文 ↗