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Acelyrin Cuts Workforce, Deprioritizes Former Lead Drug Izokibep

Acelyrin Cuts Workforce, Deprioritizes Former Lead Drug Izokibep

Acelyrin裁員,優先考慮先前主導的藥品Izokibep
Benzinga ·  08/15 00:29

On Wednesday, Acelyrin Inc. (NASDAQ:SLRN) confirmed that it was completing a 33% reduction in its workforce.

週三,Acelyrin Inc. (納斯達克股票代碼: SLRN)確認正在完成33%的員工裁員。

On June 30, the Agoura Hills, California-based company had $635.2 million in cash, cash equivalents, and short-term marketable securities. The cash runway extends to mid-2027.

截至6月30日,總部位於加州Agoura Hills的公司擁有63520萬美元的現金、現金等價物和短期可變現證券。現金儲備可延長至2027年中期。

"Consistent with our commitment to disciplined capital allocation, we have decided to focus our efforts toward rapidly advancing lonigutamab through late-stage development with our existing cash resources," said Mina Kim, CEO.

公司CEO Mina Kim表示:「與我們不斷強調資本配置紀律的承諾一致,我們已決定利用現有的現金資源,集中精力推進lonigutamab的後期開發。」

Meanwhile, Acelyrin will cease developing izokibep. The company is on the hunt for a partner to help develop the drug.

與此同時,Acelyrin將停止開發izokibep。該公司正在尋找合作伙伴協助開發這種藥物。

Acelyrin reported data from the Phase 3 trial of izokibep in hidradenitis suppurativa (HS). Izokibep demonstrated statistically significant responses across multiple efficacy endpoints at 12 weeks.

Acelyrin在hidradenitis suppurativa (HS)的3期試驗中公佈了izokibep的數據。 12周時,izokibep在多個療效終點顯示出統計學顯著的反應。

  • In higher-order endpoints, 25% of patients achieved HiSCR90, compared to 9% on placebo (p-value=0.0009), and 22% achieved HiSCR100, compared to 8% on placebo.
  • HiSCR90 and HiSCR75 are defined as at least a 90% or 75% reduction from baseline in the total abscess and inflammatory nodule count.
  • The primary endpoint was measured at 12 weeks; Acelyrin continued dosing patients in a placebo-controlled manner through week 16.
  • The company has data from two-thirds of patients in week 16, and the preliminary data demonstrates the continued deepening of HiSCR responses over time.
  • No new safety signals for izokibep were observed. The most common adverse events were mild-to-moderate injection site reactions, headache, nasopharyngitis, fatigue, and diarrhea.
  • There were no cases of candida infection, liver toxicity, or suicidal ideation/behavior in the izokibep treatment arm.
  • 在高階終點中,25%的患者達到了HiSCR90,而安慰劑組僅爲9% (p值=0.0009),22%實現了HiSCR100,而安慰劑組僅爲8%。
  • HiSCR90和HiSCR75被定義爲基線總膿腫和炎性結節數量至少降低90%或75%。
  • 主要終點評估時間爲12周;Acelyrin在16周內繼續按照安慰劑對照的方式給予患者藥物。
  • 該公司已完成16周內三分之二患者的數據收集,並且初步數據表明HiSCR反應隨時間持續深化。
  • izokibep未觀察到新的安全信號。最常見的不良事件包括輕度至中度注射部位反應、頭痛、鼻咽炎、疲勞和腹瀉。
  • izokibep治療組中未觀察到念珠菌感染、肝毒性或自殺傾向/行爲案例。

Acelyrin will complete the ongoing psoriatic arthritis (PsA) and HS trials but will suspend new investments in these indications.

Acelyrin將完成正在進行的銀屑病性關節炎(PsA)和HS試驗,但將暫停對這些適應症的新投資。

Strategic Shift: The company is prioritizing lonigutamab, signalling a "strategic shift" from izokibep.

戰略轉型:該公司將優先考慮lonigutamab,標誌着從izokibep的「戰略轉型」。

"Combined with a reduction in force, this strategic shift allows us to extend our cash runway to mid-2027 and fully fund both Phase 3 trials for lonigutamab," Kim said.

Kim表示:「加上減少人員的行動,這一戰略轉變使我們能夠將現金儲備延長至2027年中期,並充分資助lonigutamab的兩個3期試驗。」

Acelyrin has completed the Phase 1 proof-of-concept portion of the ongoing lonigutamab trial, and the dose-ranging Phase 2 portion in thyroid eye disease patients continues.

Acelyrin已完成正在進行的lonigutamab試驗第1階段的概念驗證,並繼續進行階段2試驗,該試驗涉及甲狀腺眼病患者的不同劑量和劑型。現正在測試三週或四周口服一次的劑量管理。

The Phase 2 trial tests different doses and dose regimens to establish a minimum effective dose and enable the selection of the optimal dose and dose regimen for the Phase 3 program. Dose administration every three or four weeks is now being tested.

Acelyrin計劃放棄最初計劃的第2b/3期試驗設計,並直接進入第3期試驗計劃,可能與並行試驗相結合,在2025年第一季度啓動。

Acelyrin plans to forgo the originally planned Phase 2b/3 trial design and move directly into a Phase 3 program, potentially with concurrent trials, which is anticipated to be initiated in the first quarter of 2025.

公司將在今年晚些時候與FDA進行第2階段會議。

The company will hold an end-of-Phase 2 meeting with the FDA later this year.

股價表現:截至週三,SLRN股票下跌了17.4%,至3.93美元。

Price Action: SLRN stock is down 17.4% at $3.93 at last check Wednesday.

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譯文內容由第三人軟體翻譯。


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