CNM-Au8 對多發性硬化症表現出長期改善

在 2 期臨床試驗 (VISIONARY-MS) 中，使用 Clene Nanomedicine 的 CNM-Au8 進行長期治療表明，復發緩解型多發性硬化症 (RRMS) 患者的神經和髓磷脂健康狀況在三年內持續改善。 CNM-Au8 是一種含有金奈米顆粒的口服療法，以神經細胞能量產生為目標，這是一種不同於其他多發性硬化症療法的新機制。這些發現支持 Clene 的第三階段試驗計劃和潛在的藥物批准申請。

Clene Nanomedicine's CNM-Au8 Demonstrates Long-Term Improvements in Multiple Sclerosis

Clene Nanomedicine 的 CNM-Au8 顯示對多發性硬化症的長期改善

Denver, Colorado, April 18, 2024 - Data from the three-year VISIONARY-MS clinical trial presented at the American Academy of Neurology (AAN) 2024 Annual Meeting provide further evidence of the potential therapeutic benefits of Clene Nanomedicine's experimental oral therapy CNM-Au8 in relapsing-remitting multiple sclerosis (RRMS).

科羅拉多州丹佛，2024 年4 月18 日- 在美國神經病學學會(AAN) 2024 年年會上公佈的為期三年的VISIONARY-MS 臨床試驗的數據進一步證明了Clene Nanomedicine 的實驗性口服療法CNM-Au8的潛在治療益處復發緩解型多發性硬化症（RRMS）。

Sustained Nerve and Myelin Improvements

神經和髓磷脂持續改善

Long-term treatment with CNM-Au8 led to sustained improvements in the health of nerves and myelin over three years, according to the findings. This was evident in improvements in nerve function, as measured by visual evoked potentials, and in markers of myelin repair, or remyelination, as measured by magnetic resonance imaging (MRI).

研究結果顯示，三年來長期使用 CNM-Au8 治療可以持續改善神經和髓鞘的健康狀況。這在神經功能的改善（透過視覺誘發電位測量）以及髓鞘修復或髓鞘再生標記（透過磁振造影（MRI）測量）方面表現得很明顯。

Mechanism of Action

作用機制

CNM-Au8 is a liquid suspension of gold nanoparticles that is designed to boost nerve cells' energy production. This mechanism is distinct from approved disease-modifying therapies (DMTs) for MS, which work to reduce inflammation in the brain.

CNM-Au8 是一種金奈米粒子的液體懸浮液，旨在促進神經細胞的能量產生。這種機制與已批准的多發性硬化症疾病緩解療法 (DMT) 不同，後者旨在減少大腦發炎。

Phase 3 Trial Planned

計劃進行第三階段試驗

The findings support Clene's plans to launch a Phase 3 trial of CNM-Au8 in MS. Such a trial would provide further evidence of the therapy's efficacy and safety and may support applications toward its approval.

這些發現支持 Clene 計劃在 MS 中啟動 CNM-Au8 的 3 期試驗。這樣的試驗將為該療法的有效性和安全性提供進一步的證據，並可能支持其批准申請。

VISIONARY-MS Extension Study

VISIONARY-MS 推廣研究

The VISIONARY-MS clinical trial (NCT03536559) initially tested CNM-Au8 against a placebo in 73 people with RRMS who had not had a relapse for at least six months before entering the study. After a year, those given CNM-Au8 had significant improvements in vision, suggesting that the therapy improved the health of nerve fibers in the brain.

VISIONARY-MS 臨床試驗 (NCT03536559) 最初在 73 名 RRMS 患者中測試了 CNM-Au8 與安慰劑的對比，這些患者在進入研究之前至少六個月沒有復發。一年後，接受 CNM-Au8 治療的患者視力有了顯著改善，這表明該療法改善了大腦神經纖維的健康。

Fifty-five participants from the original trial then entered into an extension study (VISIONMS-LTE; NCT04626921), where they were treated with CNM-Au8 for an additional two years, for a total of three years of treatment.

來自原始試驗的 55 名參與者隨後進入了一項擴展研究（VISIONMS-LTE；NCT04626921），他們接受 CNM-Au8 治療額外兩年，總共治療三年。

Long-Term Efficacy Data

長期療效數據

Data from the extension study showed that the improvements in vision and cognitive function observed after one year of CNM-Au8 treatment were maintained for three years. Additionally, those who switched from a placebo to CNM-Au8 in the extension study saw improvements in these measures.

擴展研究的數據顯示，CNM-Au8 治療一年後觀察到的視力和認知功能改善可維持三年。此外，那些在擴展研究中從安慰劑轉向 CNM-Au8 的人看到了這些指標的改善。

Improvements in Nerve Damage

改善神經損傷

The new data presented at AAN included further evidence that the therapy may be repairing damaged optic nerves. Visual evoked potential latency and amplitude measures improved in patients who started on CNM-Au8 in the placebo-controlled part of the trial, suggesting that the damaged optic nerves were repairing.

AAN 上公佈的新數據進一步證明該療法可能正在修復受損的視神經。在試驗的安慰劑對照部分中，開始使用 CNM-Au8 的患者的視覺誘發電位潛伏期和振幅測量有所改善，顯示受損的視神經正在修復。

Remyelination Markers

髓鞘再生標記物

MRI data also indicated that CNM-Au8 led to long-term increases in markers of myelin repair. Myelin is a fatty substance that wraps around nerve fibers to help them send electrical signals, but is damaged by the misguided inflammatory attacks in MS.

MRI 數據也顯示 CNM-Au8 導致髓磷脂修復標記物的長期增加。髓磷脂是一種脂肪物質，包裹在神經纖維周圍，幫助神經纖維發送電訊號，但會因多發性硬化症中誤導性發炎攻擊而受損。

Expert Commentary

專家評論

"These results are particularly exciting and provide a clear impetus for a Phase 3 study," said Michael Barnett, PhD, a clinical advisor for the trial, during his presentation at AAN. "The development of adjunctive therapies that not only prevent neurodegeneration, but also improve neuronal function with measurable clinical benefit, will fill a major unmet need for people living with MS."

該試驗的臨床顧問 Michael Barnett 博士在 AAN 的演講中表示：“這些結果特別令人興奮，為 3 期研究提供了明顯的推動力。” “輔助療法的開發不僅可以預防神經退化，而且可以改善神經元功能並具有可測量的臨床益處，這將滿足多發性硬化症患者未滿足的主要需求。”

"Observing such a profound clinical benefit with corresponding improvements in physiologic measures utilizing a mechanism that does not target immune system modulation has never been demonstrated in prior multiple sclerosis trials," added Benjamin Greenberg, MD, head of medicine at Clene.

Clene 醫學主任本傑明·格林伯格醫學博士補充說：「在先前的多發性硬化症試驗中，從未證明過利用不針對免疫系統調節的機制觀察到如此深遠的臨床益處以及相應的生理措施改善。 」

Conclusion

結論

The long-term data from the VISIONARY-MS clinical trial provide further evidence of the potential therapeutic benefits of Clene Nanomedicine's CNM-Au8 in RRMS. The therapy demonstrates sustained improvements in nerve and myelin health and may represent a promising new treatment option for people with this debilitating condition.

VISIONARY-MS 臨床試驗的長期數據進一步證明了 Clene Nanomedicine 的 CNM-Au8 在 RRMS 中的潛在治療效果。該療法證明了神經和髓磷脂健康的持續改善，對於患有這種衰弱疾病的人來說可能是一種有前途的新治療選擇。