NutritionTheratechnologies Presents Results From A Pharmacokinetic/Phamacodynamic Evaluation Of Tesamorelin At The Endocrine Society's Annual Meeting
Theratechnologies (TSX:TH) announced today that results from a pharmacokinetic/pharmacodynamic (PK/PD) evaluation of tesamorelin were presented as a poster (Poster number: P3-641) at the Endocrine Society"s 91st Annual Meeting in Washington D.C. Tesamorelin is an analogue of the growth hormone releasing factor evaluated for the treatment of excess abdominal fat in HIV patients with lipodystrophy.
The poster outlined the results of two Phase 1 studies performed to determine the PK/PD profiles of tesamorelin after single and multiple administrations of 2 mg of tesamorelin once daily for 14 consecutive days, in healthy volunteers and HIV-positive patients receiving a stable antiretroviral regimen. The results showed that tesamorelin"s PK/PD profiles were generally similar in both groups and suggest that there is a minimal impact on tesamorelin"s PK parameters and on the induction of the insulin-like growth factor (IGF-1) when tesamorelin is given to HIV-positive patients on antiretroviral therapy.
Levels of IGF-1 at baseline were within normal range and comparable in both groups (healthy: 175 ng/mL; HIV+: 164 ng/mL). After 14 days of daily injection, a similar increase was observed in healthy volunteers and in HIV-positive patients (115% and 121%, respectively, compared to baseline). In both studies, the extent of absorption (AUC) and the maximal concentration (Cmax) were similar (approximately 700 pgò€¢h/mL and 2400 pg/ml for AUC and Cmax, respectively). The half-life of tesamorelin ranged between 13 to 38 minutes in both healthy volunteers and HIV-positive patients.
The poster presented is now available on Theratechnologies" website at http://www.theratech.com
About HIV-Associated Lipodystrophy
Several factors including the antiretroviral drug regimen and the virus itself are thought to contribute to HIV-associated lipodystrophy, which is characterized by body composition changes, dyslipidemia and glucose intolerance. The changes in body composition include excess abdominal fat accumulation. There is currently no approved treatment available for the excess abdominal fat related to HIV-associated lipodystrophy, a condition that can stigmatize patients and discourage HIV treatment adherence.
Theratechnologies