Lactic Acidosis problems for Metabasis
San Diego-based Metabasis Therapeutics has been notified by Sankyo, its partner on the development of Metabasis' product candidate CS-917, that two serious adverse events that involved apparent lactic acidosis occurred in an interaction study with the marketed diabetes drug metformin.
San Diego-based Metabasis Therapeutics has been notified by Sankyo, its partner on the development of Metabasis' product candidate CS-917, that two serious adverse events that involved apparent lactic acidosis occurred in an interaction study with the marketed diabetes drug metformin.
The serious adverse events were resolved after medical intervention. The two patients were administered CS-917 in combination with metformin. Metformin has also been associated with lactic acidosis. The interaction study has been stopped. Also, a second study that involved administration of a relatively high dose of CS-917 to evaluate timing of dose administration is being stopped. Metabasis is not aware of any serious adverse events in this study. A third study evaluating various doses of CS-917 administered as a single agent over three months is under review. No patients are currently receiving CS-917. Metabasis will work with Sankyo, investigators and other experts to evaluate clinical data in an effort to fully understand the implications of these findings for the development of CS-917.
'Clearly we are disappointed with this news from our partner Sankyo. Although the efficacy data on CS-917 is promising, these adverse events raise safety concerns for CS-917 that we and our partner need to fully and carefully evaluate. We believe that Sankyo made the appropriate decision by halting the two studies and carefully reviewing the three-month study before administering CS-917 to any additional patients,' said Dr Paul Laikind, chairman, ceo and president of Metabasis.
What is Lactic Acidosis?
Each of the trillions of cells in our body uses energy by processing glucose and fats. This processing occurs in the power plant of our cells, the mitochondria. In normal, healthy cells, the mitochondria produce the energy we use each and every second of everyday. In this energy production, a byproduct called lactic acid is produced. The lactic acid is processed by the cell and eliminated from the body. But in instances where the mitochondria have been damaged, lactic acid builds up in our cells and blood stream resulting in Lactic Acidosis.