Galimedix Therapeutics, Completion of Phase 1 Study with GAL-101

Image credits: Optometry Times

Announcement

Galimedix Therapeutics Inc., a leading phase 2 clinical stage biotechnology company establishing topical neuroprotective and novel therapies with the capability of introducing an evolving change in the treatment of retinal and serious brain disease, confirmed its completion of the phase 1 study with orally administered GAL-101. The GAL-101 is a small molecule mainly introduced to focus on misfolded amyloid beta monomers. In the trial process, GAL-101 resulted in a clinically safe and tolerable one with no extreme adverse events. Continuously aligning with pre-clinical findings, GAL-101 was declared to be effective in crossing the blood-brain barrier, and also its pharmacokinetic (PK) profile impressively supports the advancement of the oral formulation in phase 2 development in alzheimer’s disease. The result of the entire study will be revealed at a future scientific conference.

Phase 1 Trial’s Roots

The phase 1 trial included around 100 healthy volunteers and examined the tolerability, safety, and pharmacokinetics of multiple (MAD) and single (SAD) ascending oral doses of GAL-101. The study also examined GAL-101’s potency to cross the blood-brain barrier and multiple other parameters, such as the impact of age, gender, and food. These relatable aspects need to bring Galimedix’s planned phase 2 study in alzheimer’s disease. Galimedix is also organizing the phase 2 clinical trial with GAL-101 eyedrops for dry age-based macular degeneration (dAMD), a position in the eDREAM study that is currently lined up in Europe, the US, and other regions. The development in dAMD /geographic atrophy (GA) is partner-invested, alleviating the financial exposure of Galimedix.

With this, the company will head towards the phase 2 trial that leads to a milestone profiting both investors and partners. ‘Connect with Galimedix’ is an engaging initiative by the company to involve its valued partners and investors in updates and results from the phase 2 trials. This effort aims to shape the study's success and strengthen partnerships, as well as support the company's upcoming initiatives.

Galimedix is open to discussing the stored data and investment, along with the partnering fruition with interested companies. Galimedix management will be guiding partners and investors through conferences to unlock new opportunities. The conference's venue is listed as: LSX World Congress, USA, Boston, MA, on September 15-17; the 25th annual biotech in Europe forum, Basel, Switzerland, on October 8-9; BIO-Europe, Vienna, Austria, on November 3-5, and LSX Investival, London, UK, on 17th November.