Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]
19 Décembre 2023 - 10:01PM
Edgar (US Regulatory)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF
FOREIGN PRIVATE ISSUER
PURSUANT TO SECTION 13a-16 OR
15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of December, 2023
Commission File Number: 001-36815
Ascendis Pharma A/S
(Exact Name of Registrant as Specified in Its Charter)
Tuborg
Boulevard 12
DK-2900 Hellerup
Denmark
(Address of
principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
Indicate by check mark if the registrant is submitting the Form
6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐
INCORPORATION BY REFERENCE
This report on
Form 6-K shall be deemed to be incorporated by reference into the registration statements on Form S-8 (Registration Numbers
333-203040, 333-210810, 333-211512, 333-213412,
333-214843, 333-216883, 333-228576, 333-254101,
333-261550 and 333-270088) and Form F-3 (Registration Numbers 333-209336, 333-211511, 333-216882, 333-223134, 333-225284 and
333-256571) of Ascendis Pharma A/S (the Company or Ascendis) (including any prospectuses forming a part of such registration statements) and to be a part thereof from the date on which
this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.
On December 19, 2023, the Company announced
positive topline results from foresiGHt, its Phase 3 randomized, parallel-arm, placebo-controlled (double-blind) and active-controlled (open-label) trial to compare the efficacy and safety of TransCon hGH
(lonapegsomatropin) with placebo and daily hGH (human growth hormone, somatropin) in adults with growth hormone deficiency (GHD).
The foresiGHt Trial
evaluated 259 adults with GHD aged 23 to 80 years old, randomized 1:1:1, titrated to receive a target fixed dose of TransCon hGH, placebo, or daily hGH based on age and oral estrogen intake with approximately equivalent hGH mg/week for TransCon hGH
and daily hGH.
|
|
|
TransCon hGH demonstrated superiority on its primary efficacy endpoint at Week 38: |
|
|
|
Change from baseline in trunk percent fat as measured by dual x-ray
absorptiometry (TransCon hGH -1.67% vs. placebo +0.37%, LS mean difference = -2.04%, p < 0.0001) |
|
|
|
TransCon hGH demonstrated superiority on its key secondary efficacy endpoints at Week 38: |
|
|
|
Change from baseline in total body lean mass (TransCon hGH +1.60 kg vs placebo
-0.10 kg, LS mean difference = 1.70 kg, p < 0.0001) |
|
|
|
Change from baseline in trunk fat mass (TransCon hGH -0.48 kg vs placebo
+0.22 kg, LS mean difference = -0.70 kg, p = 0.0053) |
|
|
|
Exploratory post-hoc analysis at Week 38 demonstrated comparable
treatment effect of TransCon hGH and daily hGH on target tissues. For patients with IGF-1 SDS levels ≤ 1.75 at Week 38: |
|
|
|
Change from baseline in trunk percent fat (TransCon hGH -2.42% vs. daily
hGH -2.59%) |
|
|
|
Change from baseline in total body lean mass (TransCon hGH +1.70 kg vs daily hGH +1.37 kg) |
|
|
|
Change from baseline in trunk fat mass (TransCon hGH -0.90 kg vs daily
hGH -0.94 kg) |
|
|
|
TransCon hGH was generally safe and well tolerated, with no discontinuations related to study drug and with
comparable safety and tolerability to daily hGH. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
|
|
|
|
|
|
|
|
|
|
|
Ascendis Pharma A/S |
|
|
|
|
Date: December 19, 2023 |
|
|
|
By: |
|
/s/ Michael Wolff Jensen |
|
|
|
|
|
|
Michael Wolff Jensen |
|
|
|
|
|
|
Executive Vice President, Chief Legal Officer |
Ascendis Pharma AS (NASDAQ:ASND)
Graphique Historique de l'Action
De Avr 2024 à Mai 2024
Ascendis Pharma AS (NASDAQ:ASND)
Graphique Historique de l'Action
De Mai 2023 à Mai 2024