AlzeCure Pharma has received positive results from the phase Ib clinical study with its drug candidate ACD440 for neuropathic pain.

The results demonstrate that ACD440, a TRPV1 antagonist and AlzeCure’s drug candidate for neuropathic pain within the company’s Painless platform, was able to demonstrate positive proof-of-mechanism data, showing analgesic efficacy in man, the company states in a press release. The observed effects with ACD440 were highly significant over placebo. Also, it was well tolerated as a topical gel on human skin which indicates good suitability for further clinical development, i.e. as a local treatment for neuropathic pain conditions.

“We are very pleased that ACD440 was both well-tolerated and able to show good analgesic efficacy,” says Johan Sandin, CSO at AlzeCure Pharma. “Neuropathic pain is an area with a huge unmet medical need and we believe that ACD440 could significantly improve the quality of life for patients suffering from neuropathic pain.”

Future plans

AlzeCure Pharma initiated the Phase Ib clinical study with ACD440 in December 2020. Preparations are ongoing to initiate further clinical trials and IND filing, with a planned filing for a Phase II trial by the end of 2021.

“The results from this completed proof-of-mechanism study show that ACD440 has very good characteristics and at the same time demonstrate the value of AlzeCure’s broad portfolio of projects, which together with the company’s strong cash position, provides a strong value proposition to both investors and pharma companies,” says Martin Jönsson, CEO of AlzeCure. “We are now looking forward to taking ACD440 further into Phase II studies, which may also generate even greater out-licensing interest.”

Photo of Martin Jönsson: AlzeCure Pharma