A Japanese group has begun a late-stage trial with an IPS drug for Alzheimer’s treatment.
Kyoto –Working with induced pluripotent stem (iPS) cells, researchers in Japan have started the last stage of a clinical trial for fam-Alzheimer’s disease using a new drug.
This
is the first time iPS cells are being tested so late in the iPS drug discovery
process, to find how new and existing drugs might work better, the team said on
Tuesday.
The
team consists of members from Kyoto University’s Center for iPS Cell Research
and Application (CiRA) and Towa Pharmaceutical, which produces generic
medications.
During
the trial, which started in May, the team wants to check if the treatment is
both safe and effective, with the goal of getting approval from regulators.
A
group, including CiRA professor Haruhisa Inoue, worked in 2017 to find a
compound that removes amyloid beta from iPS cells.
Bromocriptine,
which helps treat Parkinson’s, was found by their team to help patients with
familial Alzheimer’s who have a particular gene mutation.
The
trial group consisted of eight patients treated between 2020 and 2022, and all
patients showed no adverse reactions and milder changes in their thinking,
behavior, and mood.
Therefore,
more subjects were added to the trial to check whether the treatment worked and
was safe throughout the final-stage study.
Clinical
trials will take place at multiple medical centers, for example, Mie University
Hospital, nationwide from March 2027 to March 2028. It aims to include 24
patients in the experiment.
Inoue
told reporters that using a drug that is already approved allows us to give
patients treatment quicker than if we developed a new one.
Towa
will issue a generic version of the drug that the patient will receive.
Since
we make generic drugs, we should use the different drugs that are already
available, according to Itsuro Yoshida, Towa President. We plan to offer care
for diseases that are rare and unique.
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