AlzeCure Pharma AB (publ) (FN STO: ALZCUR), a pharmaceutical company that develops a broad portfolio of drug candidates for diseases affecting the central nervous system, with projects in both Alzheimer’s disease and pain, today announced that it has received approval from regulatory authorities in Germany to initiate a clinical Phase Ib study with the drug candidate ACD440.
ACD440 is a drug candidate for topical use, i.e as a gel or cream, within AlzeCure's Painless platform and focused on neuropathic pain. ACD440 has previously undergone Phase I clinical trials in which the drug candidate's tolerability has been evaluated and early efficacy signals observed.
The upcoming Phase Ib study with ACD440 has the primary study objective to evaluate safety and tolerability, as well as efficacy and so-called proof-of-mechanim data with the topical preparation. Study results are expected in H1 2021.
“Our aim has been to initiate two clinical studies before year end, and it is with great pleasure that we can announce the approval to start a Phase Ib study with ACD440, just recently after we received the approval for a clinical Phase I study with ACD856 in Alzheimer's disease. Neuropathic pain is, just as Alzheimer's, a disease area with extensive undertreatment where a majority of patients are not expected to receive adequate pain relief. The need for more effective pharmaceuticals is massive, and I look forward to starting our first study with this promising drug candidate soon,” said Martin Jönsson, CEO of AlzeCure Pharma AB.