Alkermes plc (NASDAQ:ALKS) today announced dosing of the first subject in a phase 1 study evaluating the safety and tolerability of ALKS 1140 in healthy adults. ALKS 1140 is a novel, investigational CoREST-selective (co-repressor of repressor element-1 silencing transcription factor) HDAC (histone deacetylase) inhibitor candidate for the treatment of neurodegenerative and neurological disorders. ALKS 1140 is designed to increase functional synaptic connections and synaptic integrity in the brain.
"We are pleased to advance ALKS 1140, Alkermes' first development candidate nominated from our HDAC inhibitor platform, into first-in-human studies," said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President, Research & Development at Alkermes. "Improving synaptic function may slow progression, and preserve cognitive and functional abilities, across many neurological disorders, an area with significant unmet patient need. ALKS 1140 presents an opportunity to harness the prosynaptic effects of CoREST-selective HDAC inhibitors, and we look forward to further characterizing ALKS 1140's safety and tolerability profile as we initiate our clinical program."
The primary objectives of this first-in-human, phase 1, two-part study are to assess the safety and tolerability of single (part 1) and multiple (part 2) ascending oral doses of ALKS 1140 in healthy adults. The study is also designed to characterize the pharmacokinetic and pharmacodynamic profile of ALKS 1140. The study is expected to enroll up to 80 healthy volunteers at a clinical study site in Australia.
More information can be found at www.clinicaltrials.gov, identifier: NCT05019105.