GAL-201 / Galimedix Therapeutics - LARVOL DELTA

NEW ORAL PRODRUG OF THE AΒETA-AGGREGATION MODULATOR GAL-201 SHOWS SIGNIFICANTLY IMPROVED PHARMACOKINETIC PROFILE FOR CLINICAL USE (ADPD 2026) - "Prodrug 1 demonstrated rapid and complete absorption, yielding a faster peak (15 minutes) and ~40% higher Cmax compared to the parent compound. In contrast, prodrug 2 showed incomplete absorption and did not reach a higher peak than GAL-201. Unlike the slow, biphasic absorption of GAL-201, Prodrug 1 was immediately absorbed and fully converted, leading to substantially higher systemic drug levels."

Clinical • PK/PD data • Alzheimer's Disease • CNS Disorders

Galimedix Therapeutics…presented preclinical data showcasing the improved pharmacokinetic (PK) profile of a next-generation amyloid-beta (Aβ) aggregation modulator for Alzheimer’s disease (GlobeNewswire) - "The poster, entitled, 'New oral prodrug of the Aβ aggregation modulator GAL-201 shows significantly improved pharmacokinetic profile;, was presented at the International Conference on Alzheimer’s and Parkinson’s Diseases and related neurological disorders (AD/PD2026)....Superior PK profile enables significantly reduced oral dosing amount, supporting this next-generation compound as a promising new oral development candidate for Alzheimer’s disease."

Preclinical • Alzheimer's Disease

Galimedix Therapeutics to present promising pre-clinical data with next generation oral amyloid beta aggregation modulator at AD/PD 2026 Conference (GlobeNewswire) - "The poster will discuss two prodrugs of GAL-201 and their oral bioavailability....Phase 2 development in Alzheimer’s and other indications is planned."

New P2 trial • Preclinical • Alzheimer's Disease

Galimedix Therapeutics presents compelling Phase 1 study results showing excellent safety and pharmacokinetics with oral small molecule GAL-101 at CTAD 2025 (GlobeNewswire) - "No dose-limiting adverse events were observed; all dose levels were well tolerated. GAL-101 was quickly absorbed, and plasma levels were significantly higher than the levels expected to be necessary for clinical efficacy. There was no accumulation of the drug after multiple administrations, and no relevant food effect was observed. Elderly subjects (>65 years) experienced a slightly higher exposure than younger subjects and tolerated the drug equally well....Phase 2 proof-of-concept study in Alzheimer’s disease is planned."

New P2 trial • P1 data • Alzheimer's Disease

GAL-201 as a Promising Amyloid-β-Targeting Small-Molecule Approach for Alzheimer's Disease Treatment: Consistent Effects on Synaptic Plasticity, Behavior and Neuroinflammation. (PubMed, Int J Mol Sci) - "Our results are in line with previously collected preclinical data and warrant the initiation of Investigational New Drug (IND)-enabling studies for GAL-201. By demonstrating the highly efficient detoxification of β-sheet monomers, leading to the neutralization of Aβ oligomer toxicity, GAL-201 represents a promising drug candidate against Aβ-derived pathophysiology present in AD."

Journal • Alzheimer's Disease • CNS Disorders • Inflammation

Galimedix Therapeutics completes single ascending dose part of Phase 1 study with oral small molecule, GAL-101, an amyloid beta aggregation modulator (GlobeNewswire) - "Galimedix Therapeutics, Inc...announced the completion of the single ascending dose (SAD) part of the Phase 1 study with orally administered GAL-101, a small molecule specifically designed to target misfolded amyloid beta (Aβ) monomers...In the SAD part of the study, a total of 40 healthy volunteers were randomized 3:1 to receive GAL-101 capsules or placebo capsules. The results showed that GAL-101 was well tolerated with a highly favorable safety profile. GAL-101 also demonstrated an excellent pharmacokinetic profile, strongly supporting the planned oral administration route....Galimedix also is conducting a Phase 2 clinical trial with GAL-101 eyedrops for dry AMD; the eDREAM study is expected to complete recruitment in less than a year from now."

Trial status • Dry Age-related Macular Degeneration • Ophthalmology

THE SMALL MOLECULE GAL -201 UNDER DEVELOPMENT FOR AD -TREATMENT: MODULATION OF AMYLOID -BETA AGGREGATION DIRECTLY INFLUENCES SYNAPTIC PLASTICITY BUT ALSO AFFECTS NEUROINFLAMMATION (ADPD 2025) - "These new data show that the modulation of the A β-aggregation process at source by GAL - 201 does not only impact on synaptic plasticity and behavior, but also on A β-induced neuroinflammation, which is an important component of the A β-cascade leading to neur odegeneration. As the binding motif of GAL-201 lies within the KLVFF -region, different A β isoforms ca n be targeted. Therefore, GAL -201 represents a promising drug candidate with a superior mode of action against A β-derived pathophysiology."

CNS Disorders • Inflammation

THE AMYLOID BETA AGGREGATION MODULATOR GAL-201 IS UNDER DEVELOPMENT FOR ORAL AD TREATMENT: COGNITIVE IMPROVEMENT IN A TRANSGENIC AD MODEL (ADPD 2024) - "These amyloid species have been validated by recent positive Phase 3 studies with antibody drugs, such as lecanemab as AD drug target. The available results of the animal study in the Arctic mutation AD model further strengthen the profile of GAL-201 as a promising development candidate for oral Alzheimer therapy. The next step is the initiation of the IND enabling program, before starting a classic Ph 1 SAD/MAD study."

Alzheimer's Disease • CNS Disorders

The Small Molecule GAL-201 Efficiently Detoxifies Soluble Amyloid β Oligomers: New Approach towards Oral Disease-Modifying Treatment of Alzheimer's Disease. (PubMed, Int J Mol Sci) - "Of particular note in this context is the self-propagating detoxification potential of GAL-201, leading to a neutralization of Aβ oligomer toxicity even if GAL-201 has been stepwise removed from the medium (serial dilution), likely due to prion-like conformational changes in Aβ monomer aggregates (trigger effect). The authors conclude that the data presented strongly support the further development of GAL-201 as a novel, orally available AD treatment with potentially superior clinical profile."

Journal • Alzheimer's Disease • CNS Disorders

Preferable phosphate sequestration using polymer-supported Mg/Al layered double hydroxide nanosheets. (PubMed, J Colloid Interface Sci) - "Furthermore, MgAl-201 could be easily regenerated using the NaCO-NaCl binary solution and maintained good reusability without significant capacity loss after 5 adsorption-desorption cycles. The results suggest that MgAl-201 is of great application capability for preferable phosphate sequestration in advanced wastewater treatment."

Journal

Galimedix Accelerating Development of Its Next-Generation Oral Anti-Amyloid Beta Drug GAL-201 for Alzheimer's Disease (Canada Newswire) - "Galimedix...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....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."

New P1/2 trial • Alzheimer's Disease • CNS Disorders

"#InternationalNursesDay 🩺 #IND 🩺 #FlorenceNightingale201 🩺 @ANANursingWorld 🩺 @GeorgiaNurses 🩺 @AANP_NEWS 🩺" (,@EricStreetman)

"#InternationalNursesDay 🩺 #IND 🩺 #FlorenceNightingale201 🩺 @ANANursingWorld 🩺 @GeorgiaNurses 🩺 @AANP_NEWS 🩺" (,@EricStreetman)

Newly added product (GlobeNewswire) - Preclinical, Alzheimer's Disease

Pipeline update