Bellus Health Initiates NRM8499 Phase I Trial

The randomised, double-blind, placebo-controlled study is expected to investigate the safety, tolerability and pharmacokinetic profile of NRM8499 in a group of up to 84 young and elderly healthy subjects.

NRM8499 was previously identified by Bellus Health as a compound which increases the brain exposure to tramiprosate. Preclinical studies conducted in rodents showed that NRM8499 increased plasma and brain exposure to tramiprosate by 1.5 to 3 fold.

Bellus Health believes that an increase in the exposure of tramiprosate to the brain may help improve the therapeutic effect on cognitive function and other clinical outcomes in Alzheimer’s disease.

The study entitled ‘A Phase I, Single-Center, Double-Blind, Randomised, Placebo-Controlled Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics of NRM8499 Administered as Single and Multiple Oral Doses to Healthy Young Males and Healthy Elderly Male and Female Subjects,’ will be divided in four parts, the first part will compare the safety, tolerability and pharmacokinetic of NRM8499 following a single oral administration in both young and elderly healthy subjects, to those of tramiprosate in the same conditions.

Bellus Health said that the second part is expected to assess the safety, tolerability and pharmacokinetic of up to four single ascending oral doses of NRM8499 in healthy elderly subjects. The third part will investigate the effect of food on the safety, tolerability and pharmacokinetics of NRM8499 following a single oral administration in healthy elderly subjects.

Finally, the fourth part of the study will evaluate the safety, tolerability and pharmacokinetic profile of up to three multiple ascending oral doses of NRM8499 in healthy elderly subjects.

NRM8499 has shown a benign safety profile in preclinical toxicity studies. The NRM8499 Phase I clinical study is expected to conclude in the second half of 2010.

Roberto Bellini, president and CEO of Bellus Health, said: “We are very excited about the launch of the NRM8499 Phase I clinical study. The knowledge acquired through the tramiprosate development program concerning this compound, along with our enhanced understanding of Alzheimer’s disease acquired through more than 15 years of preclinical and clinical research in this field, leads us to believe that the potential for NRM8499 is extremely promising.

“We are looking forward to the results of the study which could eventually lead to the development of the first disease-modifying treatment for Alzheimer’s disease.”