Galimedix Therapeutics has completed a phase 1 study of its oral small molecule GAL-101, an amyloid beta aggregation modulator being developed for Alzheimer’s disease.

The US-German biotech said the drug was well tolerated across more than 100 healthy volunteers, with no serious adverse events reported. The results also showed GAL-101 effectively crossed the blood-brain barrier and displayed a pharmacokinetic profile that supports once-daily oral dosing.

“Completing our first clinical trial with the oral formulation of GAL-101 is an important milestone for Galimedix,” said Alexander Gebauer, co-founder and executive chairman of Galimedix. “We are pleased that the results showed that oral GAL-101 was well tolerated with a highly favorable safety profile. Additionally, the pharmacokinetic profile strongly supports the planned administration route, as well as continued development for the treatment of Alzheimer’s disease.”

The phase 1 trial tested both single and multiple ascending doses, and also examined the effects of food, age and gender on the treatment. Full data are expected to be presented at a future scientific conference.

Galimedix now plans to launch a phase 2 trial in Alzheimer’s disease and has begun fundraising to support the programme. The company said the drug is designed to target misfolded amyloid beta monomers, a pathological hallmark of the disease.

In parallel, Galimedix is testing GAL-101 as eyedrops for dry age-related macular degeneration (dAMD). The phase 2 eDREAM trial is enrolling patients in the US, Europe and other regions. That programme is funded through a partnership, which the company said reduces its financial risk.

Gebauer added that Alzheimer’s remains an area with limited treatment options and unmet need, and that the company believes GAL-101 has potential to be developed across all stages of the disease, including mild cognitive impairment.

The results add to a crowded Alzheimer’s pipeline, where companies are increasingly pursuing therapies that intervene earlier in the disease process. Several anti-amyloid treatments have gained regulatory approval in recent years, but questions remain about durability of benefit and safety.