Post by icemandios on May 23, 2022 13:06:43 GMT
Positive Results from VISEN’s Phase 3 Trial of Once-Weekly TransCon hGH in China Consistent with Ascendis Pharma’s Phase 3 Height Trial
- VISEN’s Phase 3 Trial achieved primary endpoint; pediatric growth hormone deficiency (GHD) patients treated with TransCon™ hGH demonstrated greater annualized height velocity at 52-weeks (p=0.0010) compared to patients treated with daily growth hormone
- These results demonstrate the ability of TransCon technology to deliver consistent and reproducible results for patients across a broad range of geographies and populations
COPENHAGEN, Denmark, May 23, 2022 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) announced today that results from VISEN Pharmaceuticals’ Phase 3 trial of once-weekly TransCon hGH in children with GHD in China demonstrated results that were consistent with the Ascendis Pharma’s earlier multi-national Phase 3 trial. VISEN Pharmaceuticals’ Phase 3 trial achieved its primary endpoint, with pediatric GHD patients treated with once-weekly TransCon hGH demonstrating greater annualized height velocity at 52-weeks (p=0.0010) compared to patients treated with daily growth hormone. In both Ascendis Pharma’s and VISEN Pharmaceuticals’ Phase 3 trials, TransCon hGH – now approved in both the U.S. and EU as a once-weekly treatment for pediatric GHD – demonstrated statistical non-inferiority and superiority on the primary endpoint with comparable safety and tolerability to daily growth hormone.
“Ascendis Pharma congratulates VISEN Pharmaceuticals for successfully completing its first Phase 3 clinical trial of a TransCon product candidate in China,” said Jan Mikkelsen, Ascendis Pharma’s President and Chief Executive Officer. “These results demonstrate the ability of TransCon technology to deliver consistent and reproducible results for patients across a broad range of geographies and populations.”
Results of the Phase 3 trial of TransCon hGH in China were reported by VISEN Pharmaceuticals, whose press release can be viewed on www.visenpharma.com .
About Pediatric Growth Hormone Deficiency
Pediatric GHD is a serious orphan disease characterized by short stature and metabolic abnormalities that affect overall physical and mental health. In GHD, the pituitary gland does not produce sufficient growth hormone, which is important not only for height but also for optimal bone, heart, muscle, and brain development.
About TransCon™ Technology
TransCon refers to “transient conjugation.” The proprietary TransCon platform is an innovative technology to create new therapies that optimize therapeutic effect, including efficacy, safety and dosing frequency. TransCon molecules have three components: an unmodified parent drug, an inert carrier that protects it, and a linker that temporarily binds the two. When bound, the carrier inactivates and shields the parent drug from clearance. When injected into the body, physiologic pH and temperature conditions initiate the release of the active, unmodified parent drug in a predictable release manner. Because the parent drug is unmodified, its original mode of action is expected to be maintained. TransCon technology can be applied broadly to a protein, peptide or small molecule in multiple therapeutic areas, and can be used systemically or locally.
About Ascendis Pharma A/S
Ascendis Pharma is applying its innovative platform technology to build a leading, fully integrated biopharma company focused on making a meaningful difference in patients’ lives. Guided by its core values of patients, science and passion, the company uses its TransCon technologies to create new and potentially best-in-class therapies. Ascendis is headquartered in Copenhagen, Denmark, and has additional facilities in Heidelberg and Berlin, Germany; Palo Alto and Redwood City, California; and Princeton, New Jersey. Please visit www.ascendispharma.com to learn more.
- VISEN’s Phase 3 Trial achieved primary endpoint; pediatric growth hormone deficiency (GHD) patients treated with TransCon™ hGH demonstrated greater annualized height velocity at 52-weeks (p=0.0010) compared to patients treated with daily growth hormone
- These results demonstrate the ability of TransCon technology to deliver consistent and reproducible results for patients across a broad range of geographies and populations
COPENHAGEN, Denmark, May 23, 2022 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) announced today that results from VISEN Pharmaceuticals’ Phase 3 trial of once-weekly TransCon hGH in children with GHD in China demonstrated results that were consistent with the Ascendis Pharma’s earlier multi-national Phase 3 trial. VISEN Pharmaceuticals’ Phase 3 trial achieved its primary endpoint, with pediatric GHD patients treated with once-weekly TransCon hGH demonstrating greater annualized height velocity at 52-weeks (p=0.0010) compared to patients treated with daily growth hormone. In both Ascendis Pharma’s and VISEN Pharmaceuticals’ Phase 3 trials, TransCon hGH – now approved in both the U.S. and EU as a once-weekly treatment for pediatric GHD – demonstrated statistical non-inferiority and superiority on the primary endpoint with comparable safety and tolerability to daily growth hormone.
“Ascendis Pharma congratulates VISEN Pharmaceuticals for successfully completing its first Phase 3 clinical trial of a TransCon product candidate in China,” said Jan Mikkelsen, Ascendis Pharma’s President and Chief Executive Officer. “These results demonstrate the ability of TransCon technology to deliver consistent and reproducible results for patients across a broad range of geographies and populations.”
Results of the Phase 3 trial of TransCon hGH in China were reported by VISEN Pharmaceuticals, whose press release can be viewed on www.visenpharma.com .
About Pediatric Growth Hormone Deficiency
Pediatric GHD is a serious orphan disease characterized by short stature and metabolic abnormalities that affect overall physical and mental health. In GHD, the pituitary gland does not produce sufficient growth hormone, which is important not only for height but also for optimal bone, heart, muscle, and brain development.
About TransCon™ Technology
TransCon refers to “transient conjugation.” The proprietary TransCon platform is an innovative technology to create new therapies that optimize therapeutic effect, including efficacy, safety and dosing frequency. TransCon molecules have three components: an unmodified parent drug, an inert carrier that protects it, and a linker that temporarily binds the two. When bound, the carrier inactivates and shields the parent drug from clearance. When injected into the body, physiologic pH and temperature conditions initiate the release of the active, unmodified parent drug in a predictable release manner. Because the parent drug is unmodified, its original mode of action is expected to be maintained. TransCon technology can be applied broadly to a protein, peptide or small molecule in multiple therapeutic areas, and can be used systemically or locally.
About Ascendis Pharma A/S
Ascendis Pharma is applying its innovative platform technology to build a leading, fully integrated biopharma company focused on making a meaningful difference in patients’ lives. Guided by its core values of patients, science and passion, the company uses its TransCon technologies to create new and potentially best-in-class therapies. Ascendis is headquartered in Copenhagen, Denmark, and has additional facilities in Heidelberg and Berlin, Germany; Palo Alto and Redwood City, California; and Princeton, New Jersey. Please visit www.ascendispharma.com to learn more.