(Part three of a four-part series)
See previous parts of the series:
Next-Generation Psychedelics: The Case Of MEAI And Its Potential To Treat Addiction
Next-Generation Psychedelics, MEAI - How And Why, An Israeli Scientist Explains
MEAI is a potent synthetic molecule essentially developed in the form of a powder.
Nonetheless, for its Alcohol Use Disorder (AUD) study, developer Clearmind Medicine (NASDAQ:CMND) will create a hard-gel capsule so that the clinical trial participants can self-administer the psychedelic.
For the alcohol substitution product, the company is aiming to make MEAI take the shape of a beverage.
Several doses were tested in the preclinical stage so far. "We started from something relatively low -yet what we found to be effective in the other animal studies that we had already performed- and we went up to three times higher and three times lower considering what we found to be the effective dose in animals," CEO Dr. Zuloff-Shani explained.
This, she says, is how New Chemical Entities (NCEs) -just as MEAI- are usually developed.
See also: Psychedelics Biotech Company Raises $39M To Develop Next-Gen Treatment For Depression
The company has not yet publicly shared the effective MEAI dose, but Clearmind's CEO exclusively told Benzinga that what they found to be an effective dose in animal studies is 40 milligrams per kilogram, which translates to something like 400 milligrams on average in a person that weighs 60 kilograms.
Preclinical trials only allow for animal behavior observation. In these, MEAI treatment did not show any symptoms of anxiety or depression in rats, as compared to the control group, but they were "very active and acted quite normally."
MEAI did not appear to be a reward either. The mice had an IV system that allowed them to control the amount of substance they consumed. "When they had this possibility for cocaine, they continuously tried to get more and more, but with MEAI they did not want to get any," Zuloff-Shani explained.
Of course, Clearmind expects these results will hold for humans as well.
An upcoming Phase 1 trial is planned to be conducted in two sites in Israel and the US, following the submission of the IND clinical trial application as well as the Israeli application.
On whether the Israeli regulatory path (and approval) could be somehow faster than the process in the U.S., the answer is it varies. "Usually it is not, as Israel likes to rely on the FDA. But sometimes there are exceptions. When you have a problem like alcoholism, with a huge unmet need and not very effective treatments, it can help," says Zuloff-Shani.
Next Up: Next-Generation Psychedelics, MEAI: The Road Ahead
Photo: Benzinga edit with photo by Raimundo79 and Sergey Nivens on Shutterstock.
(四集系列文章的第三部分)
請參閱本系列的前幾部分:
下一代迷幻藥:MEAI的案例及其治療成癮的潛力
一位以色列科學家解釋說,下一代迷幻藥,MEAI-如何和為什麼
MeaI是一種強有力的合成分子,基本上是以粉末的形式開發出來的。
儘管如此,在其酒精使用障礙(AUD)研究中,開發商ClearMind Medicine(納斯達克代碼:CMND)將創建一種硬凝膠膠囊,以便臨床試驗參與者可以自行使用迷幻劑。
對於酒精替代品產品,該公司的目標是讓MEAI變成飲料的形狀。
到目前為止,在臨床前階段已經測試了幾種劑量。首席執行官祖洛夫-沙尼博士解釋說:我們從相對較低的劑量開始--但我們在已經進行的其他動物實驗中發現有效的劑量--考慮到我們在動物身上發現的有效劑量,我們的劑量增加了三倍,降低了三倍。
她說,這就是新的化學實體(NCE)--就像MEAI一樣--通常是如何發展起來的。
另見:迷幻生物技術公司籌集3900萬美元開發治療抑鬱症的下一代療法
該公司尚未公開分享MEAI的有效劑量,但ClearMind的首席執行官獨家告訴Benzinga,他們在動物研究中發現的有效劑量為每公斤40毫克,這相當於體重60公斤的人平均約400毫克。
臨床前試驗只允許觀察動物的行為。在這些實驗中,與對照組相比,MEAI治療組的大鼠沒有表現出任何焦慮或抑鬱的癥狀,但它們“非常活躍,行為相當正常”。
MeaI似乎也不是一種獎勵。這些小鼠有一個靜脈注射系統,允許它們控制自己攝入的物質的量。Zuloff-Shani解釋說:“當他們有可能獲得古柯鹼時,他們不斷地試圖獲得越來越多的古柯鹼,但對於MEAI,他們不想獲得任何古柯鹼。”
當然,ClearMind預計這些結果也適用於人類。
在IND臨床試驗申請和以色列申請提交後,計劃在以色列和美國的兩個地點進行即將到來的第一階段試驗。
至於以色列的監管途徑(和審批)是否會以某種方式比美國的過程更快,答案是不同的。Zuloff-Shani說:“通常情況下不是這樣,因為以色列喜歡依賴FDA。但有時也有例外。當你有像酒精中毒這樣的問題,有巨大的未得到滿足的需求和不是非常有效的治療方法時,它可以幫助你。”
下一個:下一代迷幻藥,MEAI:未來之路
圖片:Benzinga編輯與Raimundo79和Sergey Nivens在Shutterstock上的照片。