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Acelyrin Cuts Workforce, Deprioritizes Former Lead Drug Izokibep

Acelyrin Cuts Workforce, Deprioritizes Former Lead Drug Izokibep

Acelyrin裁员,优先考虑先前主导的药品Izokibep
Benzinga ·  08/14 12:29

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

周三,Acelyrin Inc. (纳斯达克股票代码: SLRN)确认正在完成33%的员工裁员。

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,总部位于加州Agoura Hills的公司拥有63520万美元的现金、现金等价物和短期可变现证券。现金储备可延长至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:“与我们不断强调资本配置纪律的承诺一致,我们已决定利用现有的现金资源,集中精力推进lonigutamab的后期开发。”

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

与此同时,Acelyrin将停止开发izokibep。该公司正在寻找合作伙伴协助开发这种药物。

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期试验中公布了izokibep的数据。 12周时,izokibep在多个疗效终点显示出统计学显著的反应。

  • 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.
  • 在高阶终点中,25%的患者达到了HiSCR90,而安慰剂组仅为9% (p值=0.0009),22%实现了HiSCR100,而安慰剂组仅为8%。
  • HiSCR90和HiSCR75被定义为基线总脓肿和炎性结节数量至少降低90%或75%。
  • 主要终点评估时间为12周;Acelyrin在16周内继续按照安慰剂对照的方式给予患者药物。
  • 该公司已完成16周内三分之二患者的数据收集,并且初步数据表明HiSCR反应随时间持续深化。
  • izokibep未观察到新的安全信号。最常见的不良事件包括轻度至中度注射部位反应、头痛、鼻咽炎、疲劳和腹泻。
  • izokibep治疗组中未观察到念珠菌感染、肝毒性或自杀倾向/行为案例。

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

Acelyrin将完成正在进行的银屑病性关节炎(PsA)和HS试验,但将暂停对这些适应症的新投资。

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

战略转型:该公司将优先考虑lonigutamab,标志着从izokibep的“战略转型”。

"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:“加上减少人员的行动,这一战略转变使我们能够将现金储备延长至2027年中期,并充分资助lonigutamab的两个3期试验。”

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已完成正在进行的lonigutamab试验第1阶段的概念验证,并继续进行阶段2试验,该试验涉及甲状腺眼病患者的不同剂量和剂型。现正在测试三周或四周口服一次的剂量管理。

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计划放弃最初计划的第2b/3期试验设计,并直接进入第3期试验计划,可能与并行试验相结合,在2025年第一季度启动。

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.

公司将在今年晚些时候与FDA进行第2阶段会议。

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

股价表现:截至周三,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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