Drug Discovery & Development - November 04, 2010
DARA BioSciences, Inc. announced that it has successfully completed a Phase 1 clinical study for DB959, its PPAR (peroxisome proliferator activated receptor) delta/gamma agonist, an oral drug in development for the treatment of Type 2 Diabetes. This study's main objectives were to determine the safety and pharmacokinetics of single ascending oral doses of DB959Na. Overall, the safety of DB959Na was comparable to placebo with no reports of moderate, severe, or serious adverse events in any subjects in the study. Results of pharmacokinetic measurements indicate that the compound is likely to meet the target dosing regimen of once a day, thus meeting an important goal for the program.
The study was a randomized, placebo-controlled, double-blind, escalating single dose study and enrolled 76 healthy male and female volunteers at Quintiles' Phase 1 facility in Overland Park, Kansas.
Dose escalation covered a 100-fold range in dose. The company plans to present detailed results at an upcoming scientific meeting in the first half of 2011.
As presented earlier, results of preclinical studies demonstrated that DB959 controlled glucose while raising HDL and the HDL:LDL ratio and lowering triglycerides. These beneficial effects on glucose and lipids were observed without causing the weight gain which is seen with other PPAR agonists. Given the positive results seen in this clinical trial, the company plans to initiate a multiple ascending dose trial in the first half of 2011.
Steve Grossman, MD, Medical Consultant to DARA, said, "We have gained a considerable amount of valuable information from this trial, including detailed pharmacokinetic information to help guide future studies. In addition, our observation that these subjects tolerated a 100-fold range in doses of DB959Na with no moderate, severe, or serious adverse events suggests a very good safety profile."
Richard A. Franco, CEO of DARA, said, "We are very excited by the results of this clinical study of DB959, which is now DARA's second drug candidate to be in clinical development from our pipeline. This human clinical trial supports the earlier nonclinical results which suggested a good safety profile. These data will help advance our goal of providing patients with a product that offers unique advantages over current approaches to addressing Type 2 Diabetes. These advantages include the potential for controlling dyslipidemia and an improved safety profile."
Date: November 4, 2010
Source: DARA BioSciences, Inc.
The study was a randomized, placebo-controlled, double-blind, escalating single dose study and enrolled 76 healthy male and female volunteers at Quintiles' Phase 1 facility in Overland Park, Kansas.
Dose escalation covered a 100-fold range in dose. The company plans to present detailed results at an upcoming scientific meeting in the first half of 2011.
As presented earlier, results of preclinical studies demonstrated that DB959 controlled glucose while raising HDL and the HDL:LDL ratio and lowering triglycerides. These beneficial effects on glucose and lipids were observed without causing the weight gain which is seen with other PPAR agonists. Given the positive results seen in this clinical trial, the company plans to initiate a multiple ascending dose trial in the first half of 2011.
Steve Grossman, MD, Medical Consultant to DARA, said, "We have gained a considerable amount of valuable information from this trial, including detailed pharmacokinetic information to help guide future studies. In addition, our observation that these subjects tolerated a 100-fold range in doses of DB959Na with no moderate, severe, or serious adverse events suggests a very good safety profile."
Richard A. Franco, CEO of DARA, said, "We are very excited by the results of this clinical study of DB959, which is now DARA's second drug candidate to be in clinical development from our pipeline. This human clinical trial supports the earlier nonclinical results which suggested a good safety profile. These data will help advance our goal of providing patients with a product that offers unique advantages over current approaches to addressing Type 2 Diabetes. These advantages include the potential for controlling dyslipidemia and an improved safety profile."
Date: November 4, 2010
Source: DARA BioSciences, Inc.
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