Our ongoing Phase I study is progressing as planned, with the first results expected in early July.

7/5/25, 00:00

Remynd, a clinical-stage company pioneering therapeutics for neurodegenerative diseases, is running a phase 1 trial to evaluate the safety of REM392, a second-generation septin modulator, in healthy individuals. The study is conducted following promising phase 2a data with the first-generation drug candidate in people with mild-to-moderate Alzheimer’s disease.

Belgian biotech company remynd has administered the first doses of its new Alzheimer's drug candidate in a clinical trial. In this placebo-controlled phase 1 study, the safety, tolerability and pharmacokinetics of the drug are evaluated in sixteen healthy volunteers. 

Second generation

The new study marks a key step forward in remynd’s small-molecule septin modulation program for Alzheimer’s disease, following promising results and insights gained from a prior phase 2a study with a first-generation drug candidate REM127. Last year, remynd demonstrated significant symptomatic and potential disease-modifying effects in patients with mild-to-moderate Alzheimer’s disease. That study was terminated early due to off-target adverse effects.

The new candidate, REM392, is a second-generation drug candidate with an improved safety profile and pharmacokinetics. Like its predecessor, it restores the function of septin filaments in neurons. Septin filaments help keep calcium levels in neurons balanced, but in Alzheimer’s disease, their role is disrupted by the buildup of pathological tau. The resulting imbalance contributes to the progressive loss of brain function typical for Alzheimer’s disease.

“The second-generation drug candidate represents a significant step in optimizing septin modulation for long-term use,” says Gerard Griffioen, CSO of remynd. “By evaluating the safety, tolerability, and pharmacokinetics of this new drug candidate, we aim to lay the groundwork for a Phase 2 clinical trial in patients next year.”

A different approach

Recently, Leqembi became the first disease-modifying Alzheimer’s treatment to receive approval in Europe. This antibody-based therapy works by clearing amyloid plaques from the brain and slowing disease progression in the early stages.

Remynd is taking a different approach. Its drug candidate targets a more central mechanism by restoring calcium balance in brain cells, offering three key advantages. Unlike the recently approved treatments, this drug can be taken orally. Its mechanism of action suggests it could not only relieve symptoms but also slow down the actual disease progression. As such, it could potentially be suitable for patients in both early and more advanced stages of Alzheimer’s.

“We see strong potential for our compound, both as a standalone therapy and also as part of a combination strategy—for instance in early-stage patients who are eligible for amyloid- or tau-targeting antibody treatments,” explains remynd CEO Floor Stam. 

She describes the current trial as a key milestone: “It’s an important step not only from a scientific perspective, but also strategically. It reflects our ongoing commitment to advancing safer, more effective therapies and delivering on the promise of better treatments for people affected by neurodegenerative diseases.” 

The ongoing Phase I study is progressing as planned, with the first results expected in early July. Based on these findings, remynd aims to launch a Phase 2 study in patients next year to evaluate the drug’s efficacy.

This news was covered in de Tijd, Het Nieuwsblad, and Het Belang van Limburg.