Larimar's Nomlabofusp Increases Skin Frataxin Among Participants, Stock Down In Pre-Market

Larimar Therapeutics

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(RTTNews) - Larimar Therapeutics, Inc. (LRMR), Monday announced encouraging data from the ongoing long-term open label or OL study, evaluating daily subcutaneous injections of nomlabofusp in participants with Friedreich's ataxia, a rare, progressive, and systemic disease with neurologic deterioration.

During the study, participants were initially administered 25 mg of nomlabofusp daily. Later, the dose was increased to 50 mg in the fourth quarter of 2024.

The data showed that nomlabofusp increases skin frataxin or FXN as well as achieves tissue FXN levels equivalent to more than 50 percent of those found in healthy volunteers means participants are at levels found in asymptomatic carriers who do not develop the disease. Moreover, consistent directional improvement across 4 key clinical outcomes (mFARS, FARS-ADL, 9-HPT, MFIS) were observed after 1 year of nomlabofusp treatment, suggesting potential for clinical benefit relative to a worsening in a FACOMS natural history study reference population.

Notably, anaphylaxis was reported in 7 participants in the OL study. After the most recent similar incidents, the company consulted its experts and decided to modify its starting dose regimen.

The company expects to implement the new dosing regimen in the OL study in the fourth quarter of 2025. Meanwhile, process performance qualification on the commercial scale drug substance is planned in the fourth quarter of 2025, in preparation of data for BLA submission, which is anticipated in the second quarter of 2026.

In the pre-market hours, LRMR is moving down 30.72 percent, to $3.53 on the Nasdaq.