AMLN » Topics » Pramlintide-Metreleptin Combination Product Candidate

This excerpt taken from the AMLN 10-K filed Feb 26, 2010.

Pramlintide-Metreleptin Combination Product Candidate

        In November 2007, we announced results from a 24-week proof-of-concept study with pramlintide and metreleptin combination treatment in overweight or obese subjects. At the end of the study, the combination treatment reduced body weight on average 12.7%, significantly more than treatment with pramlintide alone (8.4%). Subjects treated with pramlintide/metreleptin lost an average of 25 pounds from the beginning of the study compared with an average of 17 pounds for subjects treated with pramlintide alone. Subjects receiving pramlintide/metreleptin continued to lose weight through the end of the study compared to those treated with pramlintide alone, whose weight loss had stabilized towards the end of the study. At the beginning of the study, the average weight of study participants was approximately 205 pounds. Consistent with previous clinical experience with pramlintide/metreleptin as single agents, the most common side effects seen with combination treatment were injection site adverse events and nausea, which were mostly mild to moderate and transient in nature.

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        In July 2009, we announced results from a 28-week dose-ranging study of pramlintide/metreleptin combination treatment in overweight and obese patients. This phase 2 study characterized patients who responded best to treatment and also provided important information to inform dose selection. At 28 weeks, evaluable patients with a BMI less than 35 kg/m2 and treated with the highest pramilintide/metreleptin doses experienced significantly more weight loss on average (11% weight loss; 22 pounds) than those receiving placebo (1.8% weight loss; 4 pounds) or either agent alone (approximately 5% weight loss; 10 pounds). Consistent with the physiologic role of leptin in regulating body fat, the weight loss in these patients was predominantly due to a reduction in fat mass (approximately 18 of the 22 pounds lost).

        In February 2010, we and Takeda announced that, based on positive results from a 52-week extension of this study, the pramlintide/metreleptin combination treatment for obesity will advance toward phase 3 development. Results from the 52-week extension showed the pramlintide/metreleptin combination met the key target criteria of sustained, double-digit weight loss without evidence of cardiovascular or neuropsychiatric safety signals. Patients treated with placebo during the 52-week extension regained almost all of their weight. Consistent with the results at 28 weeks, the most robust efficacy was seen in patients with a BMI less than 35 kg/m2.

        The combination therapy was well tolerated at 52 weeks, and no cardiovascular or neuropsychiatric (such as anxiety or depression) safety signals were observed. Consistent with previous clinical experience, the most common side effects seen at 28 weeks were injection site adverse events and nausea, which were mostly mild or moderate and transient in nature. The occurrence of these side effects was much lower during the extension phase of the study.

These excerpts taken from the AMLN 10-K filed Feb 27, 2009.

Pramlintide-Metreleptin Combination Product Candidate

        In November 2007, we announced results from a 24-week proof-of-concept study with pramlintide and metreleptin combination treatment in overweight or obese subjects. At the end of the study, the combination treatment reduced body weight on average 12.7%, significantly more than treatment with pramlintide alone (8.4%). Subjects treated with pramlintide and metreleptin lost an average of 25 pounds from the beginning of the study compared with an average of 17 pounds for subjects treated with pramlintide alone. Subjects receiving pramlintide and metreleptin continued to lose weight through the end of the study compared to those treated with pramlintide alone, whose weight loss had stabilized towards the end of the study. At the beginning of the study, the average weight of study participants was approximately 205 pounds.

        Consistent with previous clinical experience with pramlintide and metreleptin as single agents, the most common side effects seen with combination treatment were injection site adverse events and nausea, which were mostly mild to moderate and transient in nature. As a result of this study we are pursuing a pramlintide-metreleptin combination product candidate. In May 2008, we announced the initiation of a six-month Phase 2B clinical study evaluating various dosing combinations of pramlintide and metreleptin and completed enrollment of this study in the third quarter of 2008. The objective of this dose-ranging study is to support dose selection for Phase 3 and to inform the ongoing development of a convenient delivery system for this combination regimen. This double-blind, placebo-controlled study has enrolled approximately 600 subjects and is expected to be completed in the second half of 2009. We plan to continue developing a delivery system that will provide both pramlintide and metreleptin in a single injection.

Pramlintide-Metreleptin Combination Product Candidate





        In November 2007, we announced results from a 24-week proof-of-concept study with pramlintide and
metreleptin combination treatment in overweight or obese subjects. At the end of the study, the combination treatment reduced body weight on average 12.7%, significantly more than treatment with
pramlintide alone (8.4%). Subjects treated with pramlintide and metreleptin lost an average of 25 pounds from the beginning of the study compared with an average of 17 pounds for subjects treated with
pramlintide alone. Subjects receiving pramlintide and metreleptin continued to lose weight through the end of the study compared to those treated with pramlintide alone, whose weight loss had
stabilized towards the end of the study. At the beginning of the study, the average weight of study participants was approximately 205 pounds.



        Consistent
with previous clinical experience with pramlintide and metreleptin as single agents, the most common side effects seen with combination treatment were injection site adverse
events and nausea, which were mostly mild to moderate and transient in nature. As a result of this study we are pursuing a pramlintide-metreleptin combination product candidate. In May 2008, we
announced the initiation of a six-month Phase 2B clinical study evaluating various dosing combinations of pramlintide and metreleptin and completed enrollment of this study in the
third quarter of 2008. The objective of this dose-ranging study is to support dose selection for Phase 3 and to inform the ongoing development of a convenient delivery system for
this combination regimen. This double-blind, placebo-controlled study has enrolled approximately 600 subjects and is expected to be completed in the second half of 2009. We plan to continue developing
a delivery system that will provide both pramlintide and metreleptin in a single injection.





These excerpts taken from the AMLN 10-K filed Feb 27, 2008.

Pramlintide-Metreleptin Combination Product Candidate

 

In November 2007, we announced results from a 24-week proof-of-concept study with pramlintide and metreleptin combination treatment in overweight or obese subjects.  At the end of the study, the combination treatment reduced body weight on average 12.7 %, significantly more than treatment with pramlintide alone (8.4%).  Subjects treated with pramlintide and metreleptin lost an average of 25 pounds from the beginning of the study compared with an average of 17 pounds for subjects treated with pramlintide alone.  Subjects receiving pramlintide and metreleptin continued to lose weight through the end of the study compared to those treated with pramlintide alone, whose weight loss had stabilized towards the end of the study.  At the beginning of the study, the average weight of study participants was approximately 205 pounds.

 

Consistent with previous clinical experience with pramlintide and metreleptin as single agents, the most common side effects seen with combination treatment were injection site adverse events and nausea, which were mostly mild to moderate and transient in nature.  As a result of this study we intend to pursue a pramlintide-metreleptin combination product candidate.  In 2008, we plan to continue developing a delivery system that will provide both pramlintide and metreleptin in a single injection.  Further, we are initiating a Phase 2B study to evaluate different dosing combinations of pramlintide and metreleptin.  We believe this six-month, multi-arm study will enroll approximately 600 patients and will take approximately one year to complete.

 

Pramlintide-Metreleptin
Combination Product Candidate



 



In November 2007, we
announced results from a 24-week proof-of-concept study with pramlintide and
metreleptin combination treatment in overweight or obese subjects.  At the end of the study, the combination
treatment reduced body weight on average 12.7 %, significantly more than
treatment with pramlintide alone (8.4%). 
Subjects treated with pramlintide and metreleptin lost an average of 25
pounds from the beginning of the study compared with an average of 17 pounds
for subjects treated with pramlintide alone. 
Subjects receiving pramlintide and metreleptin continued to lose weight
through the end of the study compared to those treated with pramlintide alone,
whose weight loss had stabilized towards the end of the study.  At the beginning of the study, the average
weight of study participants was approximately 205 pounds.



 



Consistent with previous
clinical experience with pramlintide and metreleptin as single agents, the most
common side effects seen with combination treatment were injection site adverse
events and nausea, which were mostly mild to moderate and transient in
nature.  As a result of this study we
intend to pursue a pramlintide-metreleptin combination product candidate.  In 2008, we plan to continue developing a
delivery system that will provide both pramlintide and metreleptin in a single
injection.  Further, we are initiating a
Phase 2B study to evaluate different dosing combinations of pramlintide and
metreleptin.  We believe this six-month,
multi-arm study will enroll approximately 600 patients and will take
approximately one year to complete.



 



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