(News Bulletin 247) – The Montpellier biotech has received a favorable report from the experts of the Independent Clinical Data Safety Monitoring Committee on its phase 2 clinical study for NanoLithium, its experimental treatment for Alzheimer’s disease.

Alzheimer’s disease affects more than 50 million people worldwide and to date, there is no treatment to treat and cure the main cause of dementia in the elderly.

However, hope could come from biotech Medesis Pharma. The Baillargues-based company is currently conducting a phase 2 study (intermediate stage of clinical trials) of its NanoLithium program, a project specifically targeting the alleviation of psychoses associated with the disease (memory loss, difficulty planning or solving problems, performing familiar tasks, confusion over time and place, difficulty understanding conversations, misplaced objects, social withdrawal, and often changes in mood and personality), which weigh heavily on the daily lives of patients and their loved ones .

Medesis Pharma’s approach is based on the mood-stabilizing properties of lithium (called “mood stabilizer” or “normothymic”), which has been widely used for fifty years as a basic treatment for bipolar disorders, in order to prevent psychotic relapses. But the main problem is that the therapeutically effective doses are close to toxic doses, so that the use of lithium is practically impossible for elderly and debilitated patients, as people suffering from Alzheimer’s disease often are.

So, Medesis developed Aonys, a nano-emulsion technology (nano-droplets in an assembly of lipids) making it possible to administer a medicinal active ingredient, in this case lithium, directly to the heart of the cells, with very low, therefore not very toxic, to avoid side effects.

No serious side effects

And good news for Medesis Pharma, the experts of the IDSMB (Independent Clinical Data Safety Monitoring Board) recommend continuing clinical trials. This decision was made following an initial interim review of the safety data which concerned 35 patients treated for at least one month on the date the database was established. After reviewing the data, the IDSMB experts concluded that no serious side effects were observed, that there was no safety signal and they recommend continuing the trial. as expected.

The phase 2 clinical study is underway on 68 patients affected by Alzheimer’s in 8 hospitals in France (Toulouse, Montpellier, Marseille, Paris, Strasbourg, Lille, Limoges and Lyon). It was launched in September 2021 after the agreement of the French Medicines Agency (ANSM) to test its experimental treatment NanoLithium.

The study has two phases. The first establishes a clinical report on behavioral and psychological disorders, after three months of double-blind treatment versus placebo. Then a second phase completes this preliminary stage: it establishes another clinical assessment after nine months of open treatment, without placebo to explore the potential modifying effect of NanoLithium on the disease. This time, the effects of the treatment on the cognitive manifestations (memory loss, difficulty in planning or solving problems, difficulty in understanding images and spatial relationships) and the physiopathology (imaging and biomarkers) of the disease will be observed. .

Currently, 43 patients have been included, specifies Medesis Pharma. The results of the first phase are expected at the end of 2023, and under these conditions the results of the end of the complete study could come in the 3rd quarter of 2024, adds the Montpellier biotech.

On the stock market, the favorable report of the IDSMB committee allows the title Medesis Pharma to record around 3:30 p.m. a gain of 9% (after a peak of +32.84% earlier in the morning) to 2.19 euros. But the file still drops nearly 70% since its IPO on February 12, 2021, at 6.76 euros per share.