AlzeCure’s Alzheimer’s project NeuroRestore

Alze­Cure Phar­ma, a phar­ma­ceu­ti­cal com­pa­ny that devel­ops a broad port­fo­lio of small mol­e­cule can­di­date drugs for dis­eases affect­ing the cen­tral ner­vous sys­tem, with projects in both Alzheimer’s dis­ease and pain, today announced that the com­pa­ny has received new data from the clin­i­cal phase I study (mul­ti­ple ascend­ing dose, MAD) with repeat­ed dos­ing of the drug can­di­date ACD856, which is being devel­oped against Alzheimer’s dis­ease and oth­er indi­ca­tions with cog­ni­tive dysfunction.

New data from a planned explorato­ry analy­sis of the MAD study show that ACD856 increas­es EEG activ­i­ty in the brain. A clear dif­fer­ence can be seen after ver­sus pri­or to admin­is­tra­tion of the sub­stance. This result com­bined with pre­vi­ous­ly report­ed data show that the sub­stance not only cross­es the blood-brain bar­ri­er, but also reach­es and acti­vates neur­al path­ways in the brain, with the poten­tial of hav­ing pos­i­tive effects on cognition.

The MAD phase I study is Alze­Cure’s third clin­i­cal study with ACD856, the com­pa­ny’s lead­ing drug can­di­date with­in the Neu­roRe­store plat­form. The sub­stance is under devel­op­ment as a symp­tom-reliev­ing treat­ment for med­ical con­di­tions where the cog­ni­tive abil­i­ty is impaired, for exam­ple in Alzheimer’s dis­ease. The pri­ma­ry study objec­tive was to eval­u­ate the drug can­di­date’s tol­er­a­bil­i­ty and safe­ty after repeat­ed dos­ing. As pre­vi­ous­ly report­ed, ACD856 shows good safe­ty and tol­er­a­bil­i­ty in both the SAD and MAD studies.

ACD856 and the oth­er sub­stances in the Neu­roRe­store plat­form stim­u­late sev­er­al impor­tant sig­nal­ing sys­tems and sig­nal­ing sub­stances in the brain such as BDNF (Brain Derived Neu­rotroph­ic Fac­tor) and NGF (Nerve Growth Fac­tor), which can lead to improved cog­ni­tion, some­thing that has been demon­strat­ed in pre­vi­ous pre­clin­i­cal stud­ies. New pre­clin­i­cal results also show poten­tial neu­ro­pro­tec­tive and dis­ease-mod­i­fy­ing effects with these sub­stances. The bio­log­i­cal mech­a­nism behind Neu­roRe­store enables sev­er­al indi­ca­tions, such as Alzheimer’s and Parkin­son’s dis­ease, but also trau­mat­ic brain injury and depression.

“These new data are very promis­ing and show that the sub­stance reach­es and acti­vates neur­al path­ways in the brain, whose nor­mal func­tion is dis­rupt­ed in dis­eases such as Alzheimer’s,” said Johan Sandin, CSO at Alze­Cure Pharma.

“These are very good news that add to the pre­vi­ous pos­i­tive data for ACD856 and fur­ther strength­ens our com­mer­cial oppor­tu­ni­ties for this promis­ing sub­stance,” said Mar­tin Jöns­son, CEO.