拉里玛治疗公司股票在关键研究中患者报告过敏反应后下跌-动脉网

Larimar Therapeutics Stock Falls After Patients Report Allergic Reaction In Pivotal Study

benzinga 等信源发布 2025-09-29 11:20

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Larimar Therapeutics Inc.

拉里玛治疗公司

(NASDAQ:

（纳斯达克：

LRMR

) is trading lower on Monday after the company released data from the ongoing long-term open-label (OL) study evaluating daily subcutaneous 25 mg and 50 mg injections of nomlabofusp self-administered or administered by a caregiver in participants with

周一，该公司发布了正在进行的长期开放标签（OL）研究的数据后，股价下跌，该研究评估了每日皮下注射25毫克和50毫克的nomlabofusp，由参与者自行注射或由护理人员注射。

Friedreich’s ataxia (FA)

弗里德赖希共济失调 (FA)

。

The OL study is evaluating the safety and tolerability, pharmacokinetics (PK), and FXN levels in skin and buccal cells, along with exploratory pharmacodynamic (PD) markers (lipid profiles) and clinical outcomes following long-term subcutaneous

开放标签研究正在评估长期皮下注射后的安全性、耐受性、药代动力学 (PK)、皮肤和颊细胞中的FXN水平，以及探索性的药效学 (PD) 标志物（脂质谱）和临床结果。

administration of nomlabofusp

诺姆拉博福斯的管理

。

Participants were initially administered 25 mg of nomlabofusp daily. The dose was increased to 50 mg in the fourth quarter of 2024, with all newly enrolled patients receiving the 50 mg dose since November 2024.

参与者最初每天服用25毫克的诺拉博福斯。剂量在2024年第四季度增加到50毫克，自2024年11月起，所有新入组的患者均接受50毫克的剂量。

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The company stated on Monday that 65 patients have received at least one dose of nomlabofusp in 4 completed studies and the ongoing OL study. Seven OL study participants experienced anaphylaxis and were withdrawn from the study.

公司周一表示，在 4 项已完成的研究和正在进行的 OL 研究中，已有 65 名患者至少接受过一剂 nomlabofusp。7 名 OL 研究参与者出现过敏反应并退出研究。

Most of the events occurred on the initial day of administration, and all occurred within the first 6 weeks of dosing; all participants returned to their usual state of health after receiving standard treatment.

大多数事件发生在给药的最初一天内，所有事件均发生在给药后的前6周内；所有参与者在接受标准治疗后均恢复到平时的健康状态。

Larimar consulted its experts and decided to modify its starting dose regimen.

拉里玛咨询了其专家并决定修改其起始剂量方案。

The new dosing regimen will include a 5 mg test dose followed by a 25 mg dose one hour later under observation. Nomlabofusp 25 mg will then be administered once daily for 30 days, after which the dose will be increased to 50 mg once daily.

新的给药方案将包括一个5毫克的试验剂量，一小时后在观察下给予25毫克的剂量。之后，Nomlabofusp 25毫克将每天一次给药30天，随后剂量将增加到每天一次50毫克。

Larimar plans to enroll patients aged 2-11 years directly into the OL study.

Larimar计划直接将2-11岁的患者纳入OL研究。

Other discontinuations include three cases of generalized urticaria, one seizure (the same event as

其他停药情况包括三例泛发性荨麻疹，一次癫痫发作（与前述事件相同）

reported in December 2024

2024年12月报告

), one vasovagal event, and two non-treatment-related discontinuations.

)，一次血管迷走神经事件，以及两次与治疗无关的停药。

Trends towards improvement were observed in the modified Friedreich Ataxia Rating Scale (mFARS), FARS-Activities of Daily Living (ADL), 9 Hole Peg Test (9-HPT), and Modified Fatigue Impact Scale (MFIS) at 1 year relative to baseline.

在改良的弗里德赖希共济失调评定量表（mFARS）、FARS-日常生活活动能力（ADL）、9孔插板测试（9-HPT）和改良疲劳影响量表（MFIS）中，观察到相对于基线，1年后有改善趋势。

OL study participants treated for 1 year with nomlabofusp daily demonstrated a median improvement in mFARS score of 2.25 relative to a worsening of 1.00 observed in patients in the Friedrich’s Ataxia Clinical Outcomes Measure Study (FACOMS) reference population.

开放标签研究中，接受诺拉博福斯每日治疗一年的受试者，其mFARS评分中位数改善了2.25，而弗里德赖希共济失调临床结果测量研究（FACOMS）参考人群中的患者则恶化了1.00。

Directional improvements in the other three clinical outcomes (FARS-ADL, 9-HPT, MFIS) were also observed in OL study participants, while worsening in these outcomes was observed in the FACOMS reference population.

在开放标签研究的参与者中，其他三个临床结果（FARS-ADL、9-HPT、MFIS）也观察到了方向性的改善，而在FACOMS参考人群中，这些结果却出现了恶化。

The marketing application submission to request potential accelerated approval for nomlabofusp in FA is still on track for the second quarter of 2026.

提交营销申请以请求对FA中的nomlabofusp潜在加速批准仍按计划在2026年第二季度进行。

Price Action:

价格行为：

LRMR stock is down 23.75% to $3.89 as of the last check on Monday.

截至周一的最后一次检查，LRMR股票下跌了23.75%，至3.89美元。

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