Following recent FDA approval of Biogen’s Alzheimer antibody drug ADUHELM (TM), targeting oligomers of amyloid beta, Galimedix aims for first patients with its GAL-201 oral small molecule drug within one year.
KENSINGTON, Md., June 15, 2021 /PRNewswire/ — Galimedix, Inc., a clinical-stage biopharmaceutical company focused on developing new small-molecule medicines for patients suffering from Alzheimer’s disease, glaucoma, dry AMD, and other neurodegenerative disorders, today announced an accelerated program for its promising oral small molecule GAL-201 targeting amyloid beta oligomers, the same target addressed by Biogen’s ADUHELM™ approved earlier this month.
Oral GAL-201 represents the next generation of anti-amyloid beta Alzheimer’s treatments with several clinically meaningful advantages for Alzheimer patients over antibody and other currently available drugs.
“We note that the recent and highly encouraging FDA approval of the first anti-amyloid beta drug for Alzheimer’s disease also validates the toxic oligomers of amyloid beta as a target. This opens an outstanding opportunity to advance the development of our oral small molecule GAL-201, which targets those same toxic oligomers. GAL-201 will offer patients a safe, efficacious and convenient treatment option, avoiding the limitations of current Alzheimer drugs,” stated Executive Chairman Alexander Gebauer, MD, PhD.
Hermann Russ, MD, PhD, CSO of Galimedix, added: “Our group, which has been focusing on the development of amyloid beta oligomer-targeted drugs for years, congratulates Biogen and Eisai on their successful, significant innovation for Alzheimer patients. The next step on the journey to improve treatment of Alzheimer´s after the injectable ADUHELM™ will be oral drugs with improved efficacy, safety and convenience. One such drug candidate is our tablet GAL-201. We aim to treat the first patients in a Phase 1/2a clinical trial within 12 months.”
GAL-201’s mechanism of action is unique among all current dementia pipeline projects, in that it prevents, at source, the aggregation of neurotoxic amyloid oligomers, which are known to drive the neurodegeneration in the brain. Furthermore, GAL-201 leads to an overall reduction of the amyloid beta deposits in brain tissue. Galimedix’ decision to accelerate the development of GAL-201 towards an IND submission, in the wake of FDA’s approval of the first treatment with the same target as GAL-201, is backed by a particularly strong preclinical package. GAL-201´s effects are maintained over the course of weeks without modifying normal amyloid beta or its vital functions in non-diseased neurons. Galimedix’s clinical R&D program is designed to leverage this sustained efficacy for the benefit of the patients, who may be able to go on a very convenient GAL-201 dosing regimen.
About Galimedix Therapeutics, Inc.
Galimedix, Inc. is a U.S. Delaware corporation with a team spanning Israel, Europe, and the U.S., and decades of experience in developing treatments to fight toxic amyloid oligomers and neurodegenerative diseases. The company is committed to developing innovative medicines that directly address the underlying pathology of such devastating disorders. The lead clinical candidate for Alzheimer’s disease is oral GAL-201, while GAL-101 eye drops are about to enter a Phase 2 program directed to glaucoma and dry AMD. Galimedix owns the full IP rights for this innovative technology. The company’s expertise leverages its neuropharma team’s extensive experience in industrial drug development by working together with world-leading experts in the field.