Akela sees positive Ph II results with its GHRA

Akela Pharma, a Canadian drug development company focused on therapies for the inhalation and pain markets, has announced positive final results from its pilot GHRH Phase II study. Within only four weeks of treatment, Akela GHRH induced a highly significant stimulation of endogenous growth hormone secretion and a marked increase of circulating insulin-like growth factor (IGF-1) as compared to placebo in patients with chronic kidney disease.

These endocrine effects were associated with a significant increase in fat-free mass, and concomitant reduction in fat mass when measured by DEXA scan and bioelectrical impedance As previously reported, the firm said, the study did not reveal significant changes between treatment groups in total body protein turnover. Total body protein turnover, as measured by 13C leucine kinetics, was normal in both treatment groups already at baseline, most probably reflecting adaptative changes of metabolic balance in the chronic disease state.

The study was conducted at three European sites and was designed to evaluate the clinical potential of GHRH analog (AKL-0707) administration in improving body composition, nutritional and metabolic parameters in malnourished patients with stage IV or pre-dialytic stage V chronic kidney disease (CKD). Malnutrition was defined by either serum albumin <40 g/l, body mass index (BMI) <23, or a greater than 5% loss of body weight in the last six months.