REGEnLIFE's brain-gut stimulation device fails Alzheimer's disease study

REGEnLIFE on Wednesday reported that mild-to-moderate Alzheimer's disease (AD) patients treated with its photobiomodulation technology, dubbed RGn530, showed no significant difference on cognitive performance than those given placebo in a pilot clinical trial. However, it said the device, which delivers light therapy via a modular helmet and abdominal panel to stimulate cells in the brain and gut, was well-tolerated and patients exhibited a "clear improvement trend" in a set of cognitive functions, so the company is pushing ahead with a pivotal or Phase III study. The findings were presented at the Alzheimer's and Parkinson's Diseases (AD/PD) conference.

Jacques Touchon, scientific advisor on the clinical trial, explained that RGn530 acts on early stages of the pathophysiological AD cascade, such as inflammation and oxidative stress, and suggested it "could be the non-drug complement to the next-generation therapeutic strategy." He added "this technology also makes it possible to act on both the brain and the gut, a significant advantage when we know the important role of the gut-brain axis and microbiota in neurodegenerative pathologies."

The trial involved patients with mild-to-moderate AD who were equipped with a helmet and photobiomodulation abdominal belt. Participants were randomised to treatment with RGn530 or placebo, undergoing a total of 40 sessions spread over a two-month period, with each session lasting 25 minutes. According to REGEnLIFE, 43 patients underwent the full duration of the treatment. The primary efficacy endpoint was change on the Alzheimer Disease Assessment Scale-Cognition (ADAS-Cog) scale from baseline to two months.

Positive "trends"

The company said that while the primary efficacy endpoint was not statistically met, patients in the RGn530 groups saw trends toward improved cognitive and executive functions, language comprehension and verbal memory, compared to placebo. Further, RGn530 was safe, with no major side effects reported, and had a compliance rate of 92%, which REGEnLIFE said "confirms the good tolerance of the device."

"Our initial clinical data, coupled with all our preclinical proof-of-concept studies, led us to pursue a pivotal clinical study in AD and to consider working on other neurological diseases," remarked company president Guillaume Blivet, adding that "to accelerate this new phase in our development and to shortly gain early market access, we are preparing a new funding round before the end of 2021."

Earlier this month, Cognito Therapeutics announced Phase II study results demonstrating that its digital therapeutic, which uses gamma frequency neuromodulation, helped patients with mild-to-moderate AD improve memory, cognition and functional abilities, while also reducing whole brain atrophy and volumetric loss. For related analysis, see Wider View: "Unexpected" findings to provide critical learnings for Cognito’s Alzheimer's DTx.

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