Post by luxetvox on Nov 17, 2022 20:03:47 GMT
Ascendis, Visen' once-weekly growth hormone drug beats daily hGH in Chinese
patients in trial
Ravikash, SA News Editor
Ascendis Pharma (ASND) and Visen Pharmaceuticals reported detailed results
from a phase 3 trial of their once-weekly lonapegsomatropin (TransCon hGH),
showing it was better at increasing height than daily human growth hormone
(hGH) in children with growth hormone deficiency (GHD) in China.
The companies had reported in May that the trial had met its main goal.
On Thursday, Visen said that data showed that once-weekly injection of
lonapegsomatropin demonstrated an annualized height velocity (AHV) of 10.66
cm/year compared to 9.75 cm/year for the daily hGH at 52 weeks.
Lonapegsomatropin met the trial's main goal showing that it was non-inferior
to the daily hGH.
Further analysis showed that lonapegsomatropin had superior efficacy to the
daily hGH, the company added.
Lonapegsomatropin was well tolerated with a safety profile comparable to daily
hGH, according to the company.
Visen noted that currently, most of the commercially available growth hormone
therapies in China are in the form of short-acting daily injections.
"The pivotal 52-week data released today from the China Phase 3 clinical trial
demonstrated head-to-head that once-weekly lonapegsomatropin is
non-inferiority and superior to daily hGH. The results are consistent with
Ascendis Pharma's global pivotal Phase 3 heiGHt Trial, and we look forward to
offering a new long-acting growth hormone treatment option for Chinese
patients," said Visen CEO and Executive Director Pony LU.
Visen added that lonapegsomatropin is in development in Greater China via a
license from Ascendis using the Danish company's TransCon (Transient
Conjugation) technology.
Visen has exclusive rights to develop, make and sell lonapegsomatropin in
Greater China, while the drug is globally developed by Ascendis.
Lonapegsomatropin is sold as Skytrofa in the U.S., and in the EU as TransCon
hGH to treat certain children with GHD.