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MoonLake Immunotherapeutics Starts Phase 3 VELA Program of the Nanobody Sonelokimab in Patients With Moderate-to-severe Hidradenitis Suppurativa

MoonLake Immunotherapeutics Starts Phase 3 VELA Program of the Nanobody Sonelokimab in Patients With Moderate-to-severe Hidradenitis Suppurativa

MoonLake Immunotherapeutics啓動了針對化膿性中度至重度汗腺炎患者的納米體索內洛基單抗的第三階段VELA計劃
GlobeNewswire ·  05/16 20:00

MoonLake Immunotherapeutics starts Phase 3 VELA program of the Nanobody sonelokimab in patients with moderate-to-severe hidradenitis suppurativa

MoonLake Immunotherapeutics 啓動 Nanobody 的第 3 階段 VELA 計劃 sonelokimab 用於化膿性中度至重度汗腺炎患者

  • VELA is the first Phase 3 program in hidradenitis suppurativa to use the higher clinical response level of HiSCR75 as the primary endpoint
  • VELA是化膿性汗腺炎中第一個使用更高的Hiscr75臨床反應水平作爲主要終點的3期項目
  • The topline primary endpoint readout at week 16, together with data on other endpoints, is expected as of mid-2025
  • 預計第16周的主要終端節點讀數以及其他終端的數據將於2025年中期公佈
  • Program will evaluate sonelokimab for a total of 52 weeks, across VELA-1 and VELA-2, at sites in the United States and Europe, using a design informed by the landmark Phase 2 MIRA trial
  • 該項目將採用具有里程碑意義的二期 MIRA 試驗爲靈感的設計,對索內洛基單抗在美國和歐洲的研究中心進行總計 52 周的 VELA-1 和 VELA-2 評估

Zug, Switzerland, May 16, 2024 – MoonLake Immunotherapeutics (MoonLake; Nasdaq: MLTX), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, today announced that the first patients have been screened at a U.S. trial site in its global Phase 3 clinical program, VELA, evaluating sonelokimab, an investigational Nanobody designed to treat inflammatory disease, in patients with moderate-to-severe hidradenitis suppurativa (HS).

瑞士楚格,2024年5月16日——專注於爲炎症性疾病開發更高級療法的臨床階段生物技術公司MoonLake Immunotherapeutics(MoonLake;納斯達克股票代碼:MLTX)今天宣佈,其全球3期臨床項目VELA的首批患者已在美國試驗地點接受篩查,該項目正在評估正在研究的納米體索內洛基單抗 設計用於治療中度至重度化膿性汗腺炎(HS)患者的炎症性疾病。

HS is a severely debilitating chronic skin condition, affecting up to 4.1% of the global population. Over time, uncontrolled and inadequately treated inflammation can result in irreversible tissue destruction and scarring. Sonelokimab is designed to directly target sites of inflammation by inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers and to penetrate difficult-to-reach inflamed tissues.

HS 是一種嚴重衰弱的慢性皮膚病,影響全球多達 4.1% 的人口。隨着時間的推移,不受控制和治療不當的炎症會導致不可逆轉的組織破壞和疤痕。Sonelokimab旨在通過抑制IL-17A/A、IL-17A/F和IL-17F/F二聚體來直接靶向炎症部位,並穿透難以觸及的發炎組織。

Following the positive results from the landmark Phase 2 MIRA trial, the Phase 3 VELA program is expected to enroll 800 patients across VELA-1 and VELA-2. Both trials are identical in design comparing a single 120mg dose of sonelokimab to placebo with the higher measure of clinical response, Hidradenitis Suppurativa Clinical Response (HiSCR) 75, as the primary endpoint reading out at week 16. From week 16, all patients will receive the 120mg dose of sonelokimab through to 52 weeks, followed by an open-label extension for up to two years. The Phase 3 program will use a protocol design consistent with the Phase 2 MIRA trial, which identified the optimal dose of sonelokimab for HS. The topline primary endpoint readout (week 16) from the VELA program is expected as of mid-2025.

繼具有里程碑意義的 2 期 MIRA 試驗取得積極結果之後,三期 VELA 計劃預計將招收 800 名 VELA-1 和 VELA-2 患者。這兩項試驗的設計完全相同,將單劑量的120mg的索內洛基單抗與安慰劑進行了比較,安慰劑的臨床反應較高,即化膿性汗腺炎臨床反應(HisCR)75,主要終點是第16周。從第16周起,所有患者將獲得120mg劑量的索內洛基單抗,延長至52周,然後開放標籤延長長達兩年。第三階段計劃將採用與2期MIRA試驗一致的方案設計,該試驗確定了索內洛基單抗治療HS的最佳劑量。VELA計劃的主要終點讀數(第16周)預計將於2025年中期公佈。

Kristian Reich, Founder and Chief Scientific Officer at MoonLake commented: "With real-world data indicating that at least two million Americans have been diagnosed with and treated for HS, the launch of our Phase 3 VELA program with our Nanobody sonelokimab, using the higher clinical measure of HiSCR75 as the primary endpoint and a straightforward, proven study design is a landmark moment in our efforts to develop novel treatment options for patients suffering with this under-diagnosed and under-treated condition. We are making significant progress in establishing clinical trial sites to enroll 800 patients, and we eagerly anticipate reporting the week 16 primary endpoint readout around mid-2025."

MoonLake創始人兼首席科學官克里斯蒂安·賴希評論說: “現實世界的數據表明,至少有200萬美國人被診斷出患有HS並接受了治療,因此我們使用我們的納米體啓動了第三階段VELA計劃 sonelokimab,使用更高的臨床衡量標準 Hiscr75 是 在我們努力爲患有這種診斷不足和治療不足的患者開發新的治療選擇的過程中,主要終點和直截了當、經過驗證的研究設計是一個具有里程碑意義的時刻。我們在建立可招收800名患者的臨床試驗場所方面取得了重大進展,我們熱切希望在2025年中期左右報告第16周的主要終點讀數。”

Hadar Lev-Tov, MD, MAS, Associate Professor, Director Wound Healing Fellowship, President Hidradenitis Suppurativa Foundation, Dr. Phillip Frost Department of Dermatology and Cutaneous Surgery, University of Miami, Miller School of Medicine, added: "HS is a chronic inflammatory skin condition with a range of debilitating symptoms including pain, malodorous drainage, low mood and depression. With only two FDA approved biologics, there is still an urgent need for new treatment options that treat all patient types and lesions, with the opportunity for inflammatory remission. The unique characteristics and mode of action of MoonLake's Nanobody, sonelokimab to effectively inhibit IL-17F in addition to IL-17A in deep tissue inflammation has to date shown promising outcomes, highlighting the importance of this Phase 3 program, and placing HS at the forefront of dermatological innovation."

哈達爾·列夫-托夫,醫學博士,麻醉學碩士,副教授,化膿性汗腺炎基金會主席傷口癒合研究金主任,邁阿密大學米勒醫學院皮膚科和皮膚外科系菲利普·弗羅斯特博士補充說: “HS 是一種慢性炎症性皮膚病,具有一系列使人衰弱的症狀,包括疼痛、惡臭引流、情緒低落和抑鬱。由於只有兩種獲得美國食品藥品管理局批准的生物製劑,因此仍然迫切需要新的治療方案,以治療所有患者類型和病變,並有機會緩解炎症。MoonLake 納米抗體的獨特特性和作用模式,除了 IL-17A 外,sonelokimab 還能有效抑制深層組織炎症中的 IL-17F,迄今爲止已顯示出令人鼓舞的結果,這凸顯了該三期計劃的重要性,也使HS處於皮膚病學創新的最前沿。”

Seth B Forman, MD, Principal Investigator at CenExel-FCR added: "It is with great enthusiasm that I am participating as an investigator in the Phase 3 VELA program investigating the Nanobody sonelokimab for HS, signifying a substantial advancement in addressing the critical unmet need for more treatment options for individuals living with HS. As a physician, I witness first-hand the immense demand for novel treatment options for people living with HS, particularly those that can achieve elevated response thresholds (e.g., HiSCR75 and beyond). The findings from the Phase 2 MIRA trial offer valuable insights into what may be possible as we work with our patients to establish more ambitious treatment goals and alleviate the disease burden of this debilitating condition".

Cenexel-FCR 首席研究員、醫學博士 Seth B Forman 補充說: “我以極大的熱情作爲研究員參與了VELA的三期項目,該項目旨在研究用於HS的Nanobody sonelokimab,這標誌着在解決HS患者對更多治療選擇的關鍵需求方面取得了重大進展。作爲一名醫生,我親眼目睹了HS患者對新治療方案的巨大需求,尤其是那些能夠達到較高反應閾值的患者(例如Hiscr75及以上)。MIRA二期試驗的發現爲我們與患者合作制定更雄心勃勃的治療目標並減輕這種使人衰弱的疾病負擔可能發生的事情提供了寶貴的見解”。

The initiation of this Phase 3 program follows the announcement in February 2024 of the successful outcome of MoonLake's end-of-Phase 2 interactions with the U.S. Food and Drug Administration (FDA), as well as positive feedback from its interactions with the European Medicines Agency (EMA), with both regulatory bodies unanimously supporting MoonLake's proposed approach for advancing its Phase 3 program in HS.

該第三階段計劃的啓動是在2024年2月宣佈MoonLake與美國食品藥品監督管理局(FDA)的第二階段末互動取得成功之後啓動的,其與歐洲藥品管理局(EMA)的互動也獲得了積極的反饋,這兩個監管機構一致支持MoonLake爲推進其在HS中的第三階段計劃而提出的方法。

Sonelokimab is not yet approved for use in any indication.

索內洛基單抗尚未獲準用於任何適應症。

– Ends –

— 結束 —

About the VELA program

關於 VELA 計劃

The Phase 3 VELA program is expected to enroll 800 patients across VELA-1 and VELA-2. Both global, randomized, double-blind, placebo-controlled trials are identical in design evaluating the efficacy and safety of the Nanobody sonelokimab, administered subcutaneously, in adult patients with active moderate-to-severe hidradenitis suppurativa. Similar to the design of the landmark Phase 2 MIRA trial, the primary endpoint is the percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75), defined as a ≥75% reduction in total abscess and inflammatory nodule (AN) count with no increase in abscess or draining tunnel count relative to baseline. The trials will also evaluate a number of secondary endpoints, including the proportion of patients achieving HiSCR50, the change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4), the proportion of patients achieving a Dermatology Life Quality Index (DLQI) total reduction of ≥4, the proportion of patients achieving at least 50% reduction from baseline in Numerical Rating Scale (NRS50) in the Patient's Global Assessment of Skin Pain (PGA Skin Pain) and complete resolution of Draining Tunnels (DT100). Further details are available under NCT06411379 and NCT06411899 at ClinicalTrials.gov.

第三階段 VELA 計劃預計將招收 800 名 VELA-1 和 VELA-2 患者。這兩項全球性、隨機、雙盲、安慰劑對照試驗在評估納米體的功效和安全性的設計上是相同的 sonelokimab,皮下給藥,用於活動性中度至重度化膿性汗腺炎的成年患者。與具有里程碑意義的2期MIRA試驗的設計類似,主要終點是達到化膿性汗腺炎臨床反應75(HisCr75)的參與者百分比,其定義是膿腫和炎性結節(AN)總數減少≥75%,而膿腫或引流隧道數量與基線相比沒有增加。這些試驗還將評估許多次要終點,包括達到HisCR50的患者比例、國際化膿性汗腺炎嚴重程度評分系統(IHS4)與基線的變化、皮膚科生命質量指數(DLQI)總下降≥4的患者比例、患者皮膚痛全球評估(PGA)數字評級量表(NRS50)中達到至少50%的患者比例皮膚疼痛)和排水隧道的完全解決(DT100)。更多詳情可在 ClinicalTrials.gov 的 NCT06411379 和 NCT06411899 下找到。

About Sonelokimab

關於 Sonelokimab

Sonelokimab (M1095) is an investigational ~40 kDa humanized Nanobody consisting of three VHH domains covalently linked by flexible glycine-serine spacers. With two domains, sonelokimab selectively binds with high affinity to IL-17A and IL-17F, thereby inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers. A third central domain binds to human albumin, facilitating further enrichment of sonelokimab at sites of inflammatory edema.

Sonelokimab(M1095)是一種正在研究中的約40 kDa的人源化納米體,由三個通過柔性甘氨酸-絲氨酸間隔物共價連接的VHH結構域組成。索內洛基單抗具有兩個結構域,可選擇性地與 IL-17A 和 IL-17F 高度親和力結合,從而抑制 IL-17A/A、IL-17A/F 和 IL-17F/F 二聚體。第三個中心結構域與人體白蛋白結合,促進炎性水腫部位索內洛基單抗的進一步富集。

Sonelokimab is being assessed in two lead indications, HS and psoriatic arthritis (PSA), and the Company is pursuing other indications in dermatology and rheumatology.

Sonelokimab正在評估兩種主要適應症,即HS和銀屑病關節炎(PSA),該公司正在研究皮膚病學和風溼病學方面的其他適應症。

For HS, sonelokimab is being assessed in the Phase 3 trials, VELA-1 and VELA-2, following the successful outcome of MoonLake's end-of-Phase 2 interactions with the FDA and as well as positive feedback from its interactions with the EMA announced in February 2024. In June 2023, topline results of the MIRA trial (NCT05322473) at 12 weeks showed that the trial met its primary endpoint, the Hidradenitis Suppurativa Clinical Response (HiSCR)75, which is a higher measure of clinical response versus the HiSCR50 measure used in other clinical trials, setting a landmark milestone. In October 2023, the full dataset from the MIRA trial at 24 weeks showed that maintenance treatment with sonelokimab led to further improvements in HiSCR75 response rates and other high threshold clinical and patient relevant outcomes. The safety profile of sonelokimab in the MIRA trial was consistent with previous trials with no new safety signals detected.

在HS方面,繼MoonLake與美國食品藥品管理局的2期末相互作用取得成功結果以及2024年2月宣佈的與EMA的相互作用獲得積極反饋之後,索內洛基單抗正在3期試驗(VELA-1 和 VELA-2)中接受評估。2023年6月,爲期12周的MIRA試驗(NCT05322473)的主要結果顯示,該試驗達到了其主要終點——化膿性汗腺炎臨床反應(HiSCR)75,與其他臨床試驗中使用的HiSCR50指標相比,該試驗更能衡量臨床反應,樹立了具有里程碑意義的里程碑。2023年10月,爲期24周的MIRA試驗的完整數據集顯示,索內洛基單抗的維持治療進一步提高了Hiscr75的反應率以及其他高閾值的臨床和患者相關結果。索內洛基單抗在MIRA試驗中的安全性與先前的試驗一致,未檢測到新的安全信號。

For PsA, Phase 3 initiation is anticipated in Q4 2024 following the announcement in March 2024 of the full dataset from the global Phase 2 ARGO trial (M1095-PSA-201) evaluating the efficacy and safety of the Nanobody sonelokimab over 24 weeks in patients with active PsA. Significant improvements were observed across all key outcomes, including approximately 60% of patients treated with sonelokimab achieving an American College of Rheumatology (ACR) 50 response and Minimal Disease Activity (MDA) at week 24. This followed the positive top-line results in November 2023, where the trial met its primary endpoint with a statistically significant greater proportion of patients treated with either sonelokimab 60mg or 120mg (with induction) achieving ACR50 response compared to those on placebo at week 12. All key secondary endpoints in the trial were met for the 60mg and 120mg doses with induction. The safety profile of sonelokimab in the ARGO trial was consistent with previous trials with no new safety signals detected.

對於psA,繼2024年3月公佈全球2期ARGO試驗(M1095-PSA-201)的完整數據集之後,預計將在2024年第四季度啓動第三階段,該試驗評估了納米體索內洛基單抗在24周內對活性psA患者的療效和安全性。觀察到所有關鍵結局都有顯著改善,包括大約60%的接受sonelokimab治療的患者在第24周達到了美國風溼病學會(ACR)50的反應和最低疾病活動(MDA)。這是在 2023 年 11 月取得積極的頂線結果之後,該試驗達到了其主要終點,與第 12 周服用安慰劑的患者相比,接受索諾基單抗 60 毫克或 120 毫克(誘導)治療的患者獲得 ACR50 反應的比例在統計學上顯著增加。60mg和120mg的誘導劑量滿足了該試驗的所有關鍵次要終點。索內洛基單抗在ARGO試驗中的安全性與先前的試驗一致,未檢測到新的安全信號。

A Phase 2 trial is expected to be initiated in 2024 for palmo-plantar pustulosis (PPP), a debilitating inflammatory skin condition affecting a significant number of patients. In addition, a Phase 3 trial is expected to initiate in juvenile HS, a condition that typically manifests at this early stage of a patient's life, and the period in which irreversible damage and inflammatory remission is most critical.

一項針對手掌足底膿皰病(PPP)的2期試驗預計將於2024年啓動,這是一種影響大量患者的使人衰弱的炎症性皮膚病。此外,預計將在青少年HS中啓動3期試驗,這種疾病通常出現在患者生命的早期階段,也是不可逆損傷和炎症緩解最爲關鍵的時期。

Sonelokimab will also be assessed in seronegative spondyloarthritis with Phase 2 trials in radiographic and non-radiographic axial spondyloarthritis (axSpA) and PsA expected to start in 2024. The trials are set to incorporate innovative designs that enhance traditional clinical outcomes with contemporary tissue and cellular imaging techniques.

Sonelokimab還將在血清陰性脊柱關節炎中接受評估,射線照相和非射線照相軸向脊柱關節炎(axSPA)和pSA的2期試驗預計將於2024年開始。這些試驗將採用創新設計,利用當代組織和細胞成像技術增強傳統臨床結果。

Sonelokimab has also been assessed in a randomized, placebo-controlled Phase 2b trial (NCT03384745) in 313 patients with moderate-to-severe plaque-type psoriasis. High threshold clinical responses (Investigator's Global Assessment Score 0 or 1, and Psoriasis Area and Severity Index 90/100) were observed in patients with moderate-to-severe plaque-type psoriasis. Sonelokimab was generally well tolerated, with a safety profile similar to the active control, secukinumab (Papp KA, et al. Lancet. 2021; 397:1564-1575).

一項針對313名中度至重度斑塊型牛皮癬患者的隨機、安慰劑對照的2b期試驗(NCT03384745)也對索內洛基單抗進行了評估。在中度至重度斑塊型牛皮癬患者中觀察到高閾值臨床反應(研究者的全球評估分數爲0或1,銀屑病面積和嚴重程度指數爲90/100)。Sonelokimab 的耐受性總體良好,其安全性與主動對照組 secukinumab 相似(Papp KA 等人。《柳葉刀》,2021;397:1564-1575)。

In an earlier Phase 1 trial in patients with moderate-to-severe plaque-type psoriasis, sonelokimab has been shown to decrease (to normal skin levels) the cutaneous gene expression of pro-inflammatory cytokines and chemokines (Svecova D. J Am Acad Dermatol. 2019;81:196–203).

在較早的一項針對中度至重度斑塊型牛皮癬患者的1期試驗中,索內洛基單抗已被證明可以降低(至正常皮膚水平)促炎細胞因子和趨化因子的皮膚基因表達(Svecova D. J Am Acad Dermatol。2019;81:196 —203)。

About Nanobodies

關於納米抗體

Nanobodies represent a new generation of antibody-derived targeted therapies. They consist of one or more domains based on the small antigen-binding variable regions of heavy-chain-only antibodies (VHH). Nanobodies have a number of potential advantages over traditional antibodies, including their small size, enhanced tissue penetration, resistance to temperature changes, ease of manufacturing, and their ability to be designed into multivalent therapeutic molecules with bespoke target combinations.

納米抗體 代表新一代抗體衍生的靶向療法。它們由基於重鏈抗體(VHH)的小抗原結合可變區域的一個或多個結構域組成。納米抗體 與傳統抗體相比,具有許多潛在的優勢,包括體積小、組織穿透力強、耐溫度變化、易於製造,以及能夠設計成具有定製靶標組合的多價治療分子。

The terms Nanobody and Nanobodies are trademarks of Ablynx, a Sanofi company.

“納米體” 這兩個術語 和納米抗體 是賽諾菲旗下公司Ablynx的商標。

About Hidradenitis Suppurativa

關於化膿性汗腺炎

Hidradenitis suppurativa is a severely debilitating chronic skin condition resulting in irreversible tissue destruction. HS manifests as painful inflammatory skin lesions, typically around the armpits, groin, and buttocks. Over time, uncontrolled and inadequately treated inflammation can result in irreversible tissue destruction and scarring. The disease affects 0.05–4.1% of the global population, with three times more females affected than males. Real-world data in the US indicates that at least 2 million unique patients have been diagnosed with and treated for HS between 2016 and 2023 alone, highlighting a significant unmet need and impact on healthcare systems, and a market opportunity exceeding $10bn by 2035. Onset typically occurs in early adulthood and HS has a profound negative impact on quality of life, with a higher morbidity than other dermatologic conditions. There is increasing scientific evidence to support IL-17A- and IL-17F-mediated inflammation as a key driver of the pathogenesis of HS, with other identified risk factors including genetics, cigarette smoking, and obesity.

化膿性汗腺炎是一種嚴重衰弱的慢性皮膚病,會導致不可逆轉的組織破壞。HS 表現爲疼痛的炎症性皮膚病變,通常出現在腋下、腹股溝和臀部周圍。隨着時間的推移,不受控制和治療不當的炎症會導致不可逆轉的組織破壞和疤痕。該疾病影響全球人口的0.05-4.1%,受影響的女性是男性的三倍。美國的真實數據表明,僅在2016年至2023年期間,就有至少200萬名獨特的患者被診斷出患有HS並接受了治療,這凸顯了醫療保健系統的重大需求未得到滿足和影響,到2035年,市場機會將超過100億美元。發病通常發生在成年初期,HS 對生活質量有深遠的負面影響,其發病率高於其他皮膚病。越來越多的科學證據支持 IL-17A 和 IL-17F 介導的炎症是 HS 發病機制的關鍵驅動因素,其他已確定的風險因素包括遺傳、吸菸和肥胖。

About MoonLake Immunotherapeutics

關於 MoonLake 免疫療法

MoonLake Immunotherapeutics is a clinical-stage biopharmaceutical company unlocking the potential of sonelokimab, a novel investigational Nanobody for the treatment of inflammatory disease, to revolutionize outcomes for patients. Sonelokimab inhibits IL-17A and IL-17F by inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers that drive inflammation. The company's focus is on inflammatory diseases with a major unmet need, including hidradenitis suppurativa and psoriatic arthritis – conditions affecting millions of people worldwide with a large need for improved treatment options. MoonLake was founded in 2021 and is headquartered in Zug, Switzerland. Further information is available at .

MoonLake Immunotherapeutics是一家處於臨床階段的生物製藥公司,它釋放了用於治療炎症性疾病的新型在研納米抗體sonelokimab的潛力,可以徹底改變患者的預後。Sonelokimab 通過抑制導致炎症的 IL-17A/A、IL-17A/F 和 IL-17F/F 二聚體來抑制 IL-17A 和 IL-17F。該公司的重點是主要需求未得到滿足的炎症性疾病,包括化膿性汗腺炎和銀屑病關節炎,這些疾病影響着全球數百萬人,迫切需要改善治療方案。MoonLake成立於2021年,總部位於瑞士楚格。更多信息可在以下網址獲得。

Cautionary Statement Regarding Forward Looking Statements

關於前瞻性陳述的警示聲明

This press release contains certain "forward-looking statements" within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements regarding MoonLake's expectations, hopes, beliefs, intentions or strategies regarding the future including, without limitation, statements regarding: plans for and timing of clinical trials, including the topline primary endpoint readout for the Phase 3 VELA program, the trial design and patient enrollment across the VELA-1 and VELA-2 trials, the initiation of the Phase 3 program in PsA, commencement of clinical trials of sonelokimab in PPP, juvenile HS and seronegative spondyloarthritis, the efficacy and safety of sonelokimab for the treatment of HS and PsA, including in comparison to existing standards or care or other competing therapies, clinical trials and research and development programs and the anticipated timing of the results from those studies and trials. In addition, any statements that refer to projections, forecasts, or other characterizations of future events or circumstances, including any underlying assumptions, are forward- looking statements. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "possible," "potential," "predict," "project," "should," "would" and similar expressions may identify forward-looking statements, but the absence of these words does not mean that statement is not forward looking.

本新聞稿包含1995年《美國私人證券訴訟改革法》所指的某些 “前瞻性陳述”。前瞻性陳述包括但不限於關於MoonLake對未來的預期、希望、信念、意圖或戰略的陳述,包括但不限於以下方面的陳述:臨床試驗的計劃和時間,包括3期VELA計劃的關鍵終點讀數、VELA-1 和 VELA-2 試驗的試驗設計和患者入組、在PSA啓動3期計劃、開始索內洛基單抗的臨床試驗 PPP、幼年 HS 和血清陰性脊柱關節炎,sonelokimab治療HS和psA的療效和安全性,包括與現有標準或護理或其他競爭療法、臨床試驗和研發計劃的比較,以及這些研究和試驗得出結果的預期時間。此外,任何涉及未來事件或情況的預測、預測或其他描述的陳述,包括任何基本假設,均爲前瞻性陳述。“預期”、“相信”、“繼續”、“可能”、“估計”、“預期”、“打算”、“可能”、“計劃”、“可能”、“潛在”、“預測”、“項目”、“應該”、“將” 等詞語以及類似的表述可以識別前瞻性陳述,但這些詞語的缺失並不意味着該陳述不是前瞻性的。

Forward-looking statements are based on current expectations and assumptions that, while considered reasonable by MoonLake and its management, as the case may be, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with MoonLake's business in general and limited operating history, difficulty enrolling patients in clinical trials, state and federal healthcare reform measures that could result in reduced demand for MoonLake's product candidates and reliance on third parties to conduct and support its preclinical studies and clinical trials and the other risks described in or incorporated by reference into MoonLake's Annual Report on Form 10-K for the year ended December 31, 2023 and subsequent filings with the Securities and Exchange Commission.

前瞻性陳述基於當前的預期和假設,儘管MoonLake及其管理層認爲這些預期和假設是合理的,但本質上是不確定的。新的風險和不確定性可能會不時出現,因此不可能預測所有的風險和不確定性。由於各種風險和不確定性,實際結果可能與此類前瞻性陳述中的預期存在重大差異,其中包括但不限於與MoonLake總體業務相關的風險和不確定性以及有限的運營歷史、難以招收患者參與臨床試驗、可能導致對MoonLake候選產品的需求減少的州和聯邦醫療改革措施以及依賴第三方進行和支持其臨床前研究和臨床試驗以及其他風險在MoonLake截至2023年12月31日止年度的10-K表年度報告以及隨後向美國證券交易委員會提交的文件中描述或以引用方式納入其中。

Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. MoonLake does not undertake or accept any duty to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or in the events, conditions or circumstances on which any such statement is based.

本新聞稿中的任何內容均不應被視爲任何人陳述將實現此處提出的前瞻性陳述或此類前瞻性陳述的任何預期結果將實現。您不應過分依賴本新聞稿中的前瞻性陳述,這些陳述僅代表截至發佈之日,並參照此處的警示陳述對前瞻性陳述進行了全面限定。MoonLake不承擔或接受任何義務公開發布對任何前瞻性陳述的任何更新或修訂,以反映其預期或任何此類陳述所依據的事件、條件或情況的任何變化。

MoonLake Immunotherapeutics Investors
Matthias Bodenstedt, CFO
info@moonlaketx.com

MoonLake 免疫療法投資者
Matthias Bodenstedt,首席財務官
info@moonlaketx.com

MoonLake Immunotherapeutics Media
Patricia Sousa
media@moonlaketx.com

MoonLake 免疫療法媒體
帕特里夏·索薩
media@moonlaketx.com

ICR Consilium
Mary-Jane Elliott, Namrata Taak, Ashley Tapp
Tel: +44 (0) 20 3709 5700
MoonLake@consilium-comms.com

ICR Consilium
瑪麗-簡·埃利奧特、納姆拉塔·塔克、阿什利·塔普
電話:+44 (0) 20 3709 5700
MoonLake@consilium-comms.com


譯文內容由第三人軟體翻譯。


以上內容僅用作資訊或教育之目的,不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
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