Mediforum said Thursday it has verified the safety and efficacy of PM012, a dementia treatment candidate, in its phase 2a clinical trial as the company heads into the phase 3 clinical trial for the drug.
“As the company has confirmed significant therapeutic efficacy and safety of the treatment through a long-term follow-up clinical trial that administered different doses of the drug, we believe that we will succeed in phase 3 clinical trials, too,” a company official said.
The company conducted a two-year follow-up clinical trial with two dosing groups and placebo group in phase 2 clinical trial of PM012 at four institutions, including Kyunghee University Korean Medicine Hospital and St. Mary's Hospital.
As a result, the research showed a significant change it the Alzheimer's Disease Assessment Scale-Cog scores for the two dosing groups when compared with the placebo group. The company also confirmed no clinically significant adverse reactions.
In particular, in the non-clinical study of animal models that induced acute dementia before clinical phase 2a trials, PM012 helped recover consistent memory and spatial perception capacity by 30 to 40 percent compared to the control group.
Also, it was effective in the regeneration of neurons in the brain hippocampal region, thus confirming the possibility of treatment as well as prevention and maintenance of dementia.
Compared with donepezil, which is a well-known dementia inhibitor, the company said it confirmed the ability of the brain to metabolize the body significantly increased.