Post by luxetvox on Sept 25, 2023 12:57:53 GMT
While Opko seems vaccinated against any infection that would resemble meaningful news, Ascendis continues to release info to investors, this latest coming on a Saturday.
Ascendis Pharma Presents Results from Long-Term enliGHten Trial of TransCon™
hGH in Pediatric Growth Hormone Deficiency
- The majority of children and adolescents treated once weekly with TransCon
hGH (lonapegsomatropin) met or exceeded average parental height SDS at time of
treatment completion or last visit
- Trial demonstrated the long-term safety of TransCon hGH in patients treated
up to 6 years
COPENHAGEN, Denmark, Sept. 23, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S
(Nasdaq: ASND) today announced results from enliGHten, the Company’s
open-label extension trial evaluating the long-term safety and efficacy of
TransCon hGH as a once-weekly treatment for children and adolescents with
growth hormone deficiency (GHD). Results were shared today in Poster LB-17 at
ESPE 2023, the annual meeting of the European Society for Paediatric
Endocrinology being held in The Hague, September 21-23.
The enliGHten trial enrolled 298 participants (mean age 10.3 years) from the
Phase 3 heiGHt Trial of treatment-naĂŻve pediatric GHD patients and the Phase 3
fliGHt Trial of pediatric GHD patients switching from daily somatropin
treatment. Patients in these trials received a total of up to 6 years of
treatment with TransCon hGH.
At the time of the enliGHten Trial conclusion, 81 participants were designated
as treatment completers, based on their physician’s determination that
treatment for pediatric GHD was no longer required. Of these treatment
completers, 59% met or exceeded their average parental height SDS, with mean
TransCon hGH treatment duration of 3.2 years. Treatment completers’ baseline
mean height standard deviation score (SDS) at the beginning of the open-label
extension trial was -1.6, compared to mean height SDS of -0.4 (achieving
height similar to their parents’) at their final study visit. At the time of
final visit, all treatment completers were Tanner stage IV or V, a
categorization of physical development during puberty.
“As an investigator in the enliGHten Trial, I am pleased to see results
confirming that treated children and adolescents have continued to grow well,
achieving statures in line with those of their parents,” said Aristides K.
Maniatis, M.D., F.A.A.P., pediatrician and endocrinologist at Rocky Mountain
Pediatric Endocrinology. “Additionally, these results demonstrate that
long-term treatment goals can be safely reached with TransCon hGH administered
once weekly.”
TransCon hGH was generally safe and well-tolerated. The most commonly reported
adverse events over the course of the trial were categorized as infections,
injury, and respiratory/thoracic/medical disorders. The majority of adverse
events were mild in severity and unrelated to treatment. No adverse events led
to discontinuation of the study treatment.
Ascendis Pharma Presents Results from Long-Term enliGHten Trial of TransCon™
hGH in Pediatric Growth Hormone Deficiency
- The majority of children and adolescents treated once weekly with TransCon
hGH (lonapegsomatropin) met or exceeded average parental height SDS at time of
treatment completion or last visit
- Trial demonstrated the long-term safety of TransCon hGH in patients treated
up to 6 years
COPENHAGEN, Denmark, Sept. 23, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S
(Nasdaq: ASND) today announced results from enliGHten, the Company’s
open-label extension trial evaluating the long-term safety and efficacy of
TransCon hGH as a once-weekly treatment for children and adolescents with
growth hormone deficiency (GHD). Results were shared today in Poster LB-17 at
ESPE 2023, the annual meeting of the European Society for Paediatric
Endocrinology being held in The Hague, September 21-23.
The enliGHten trial enrolled 298 participants (mean age 10.3 years) from the
Phase 3 heiGHt Trial of treatment-naĂŻve pediatric GHD patients and the Phase 3
fliGHt Trial of pediatric GHD patients switching from daily somatropin
treatment. Patients in these trials received a total of up to 6 years of
treatment with TransCon hGH.
At the time of the enliGHten Trial conclusion, 81 participants were designated
as treatment completers, based on their physician’s determination that
treatment for pediatric GHD was no longer required. Of these treatment
completers, 59% met or exceeded their average parental height SDS, with mean
TransCon hGH treatment duration of 3.2 years. Treatment completers’ baseline
mean height standard deviation score (SDS) at the beginning of the open-label
extension trial was -1.6, compared to mean height SDS of -0.4 (achieving
height similar to their parents’) at their final study visit. At the time of
final visit, all treatment completers were Tanner stage IV or V, a
categorization of physical development during puberty.
“As an investigator in the enliGHten Trial, I am pleased to see results
confirming that treated children and adolescents have continued to grow well,
achieving statures in line with those of their parents,” said Aristides K.
Maniatis, M.D., F.A.A.P., pediatrician and endocrinologist at Rocky Mountain
Pediatric Endocrinology. “Additionally, these results demonstrate that
long-term treatment goals can be safely reached with TransCon hGH administered
once weekly.”
TransCon hGH was generally safe and well-tolerated. The most commonly reported
adverse events over the course of the trial were categorized as infections,
injury, and respiratory/thoracic/medical disorders. The majority of adverse
events were mild in severity and unrelated to treatment. No adverse events led
to discontinuation of the study treatment.
