Santhera’s LIONHEART Study with AGAMREE® (Vamorolon) said positive Topline-Ergebnisse and einzigartigen Mineralokorticoid-Rezeptor-Antagonismus

Pratteln, Switzerland, October 1, 2024 – Santhera Pharmaceuticals (SIX: SANN) has carried out the positive research into the LIONHEART study, which uncouples the einzigartige Wirkung of Vamorolon also the mineralokorticoid receptor antagonist best and also other short steroids.

The LIONHEART study, a randomized, randomized, Placebo and Eplerenone control trial involving 30 people using professional bands, entered the first endpoint. There are a number of statistically significant results of urinary sodium/potassium ratios in the Vamorolone group in the form of placebo (p

Recurrence with cardiomyopathy is one of the major causes of morbidity and mortality in young people with Duchenne Muscular Dystrophy (DMD). When the treatment with short-term steroids (and ACE hemmers) causes a treatment of the cardiomyopathy, the standard treatment by MRAs, a simple treatment, can cause a connection with the systolic dysfunction, while in other words they work herem Beginn der Therapie zunimmt ( 1 -3).

“Mineralokorticoid receptor antagonists were urgently used, but should always be avoided first, if the function of the brain is resolved, and in the rule there is a difference in the magnetic resonance imaging of myocardial fibrosis,” it is clear. Prof. Karim Wahbi, PhD, MD, Cardiologist at APHP Hospital Cochin, Paris, France. “Particularly interesting and mechanistic research is the fragmentation, it is a synergistic usefulness of the entzündungshemmenden and MRA effects of Vamorolon on the Verlauf von Herzerkrankungen in Kindern gibt, who früh mit der Behandlung started, or ob Vamorolon for diejenigen Patients von Vorteil sein It appears that the symptoms of the disease are occurring and a short-term steroid may work.”

“The LIONHEART Study is a more important study for the cardioprotective potential of Vamorolone,” says Shabir Hasham, MD, chief medical officer of Santhera. “With the same data from patients who have been on Vamorolone all their lives, the long-lasting features of the disease are one of the positive consequences of the cardial complication in DMD.”

Über AGAMREE® (Vamorolon)
AGAMREE is a new device with a twist mechanism, which works on the binding and close range with short-term reductions, but it is possible that the action will be changed. This is an essential substrate for the 11-β-Hydroxysteroid Dehydrogenase (11β-HSD) Enzyme, which is responsible for its local activity level and the short steroid association toxin in topical compounds (4-7). This mechanism has the potential to link the steroids to the steroids, we will use AGAMREE as a dissociative agent and alternative to the best short steroids, of the standard therapy for children and adolescents with DMD, positioned (4-7).

In the relevant VISION-DMD study, AGAMREE is the first endpoint of the upward path (TTSTAND) in the placebo study (p = 0.002) after 24 studies and a large number of Sicherheits- en Verträglichkeitsprofil (4-7). Die am häufsten reportedeten Nebenwirkungen were cushingoides Aussehen, Erbrechen, Wetzunahme und Reizbarkeit. I was all the Nebenwirkungen von leichtem bis mittlerem Schweregrad.

Derzeit versügbaren daten, als AGAMREE, in the short steroids, in the series as dual mineralokortikoid antagonist and dissoziative glucokortikoid agonist ist (7). It was not even a (8) and a negative influence on the knot structure, had disappeared due to the normal serum marker for knot development and resorption (9).

AGAMREE (Vamorolon), an Arzneimittel for seltene Krankheiten, ist in de USA (prescribing information), de European Union (Zusammenfassung der Merkmale des Arzneimittels) en in de Vereinigten Königreich voor de Anwendung Zugelassen.

Über LIONHEART
The LIONHEART Study (SNT-I-VAM-026) acts as an attack, randomized, three-armed, Placebound- and Eplerenone-controlled parallel study studies into the action of Vamorolone as a Mineralokortikoid-Rezeptor-Antagonist (MRA) in 30 Erwachsenen cases male patients after the use of fludrocortisone, are also able to use mineralocorticoid receptor agonists. The main terminal point acts as the ratio of Natrium zu Kalium (Na/K) and the extended logarithms of the ratios (log₁₀ (10*Na/K) in de Urin zu verschiedenen Zeitpunkten definiert. Further analysis of the data is underway and could be carried out at medical conferences.

Literature reference:
(1) Birnkrant et al. (2018) Lancet Neurol. 2018 Apr;17(4):347-361. doi: 10.1016/S1474-4422(18)30025-5.
(2) Raman et al. (2015) Lancet Neurol 14: 153-161 doi:10.1016/s1474-4422(14)70318-7
(3) Raman et al. (2017) Orphanet J Rare Dis 12: 39. doi: 10.1186/s13023-017-0590-8
(4) Dang UJ et al. (2024) Neurology 2024;102:e208112. doi.org/10.1212/WNL.0000000000208112. Link.
(5) Guglieri M et al. (2022). JAMA Neurol. 2022;79(10):1005-1014. doi:10.1001/jamaneurol.2022.2480. Link.
(6) Liu X et al. (2020). Proc Natl Acad Sci USA 117:24285–24293
(7) Heier CR et al (2019). Life Science Alliance DOI: 10.26508
(8) Ward et al., WMS 2022, FP.27 – Poster 71. Link.
(9) Hasham et al., MDA 2022 Poster Presentation. Link.

Uber Duchenne Muscular Dystrophy
Duchenne Muscular Dystrophy (DMD) is a selten, due to the X-Chromosome effect, that is quickly extracted from the body. DMD is a part that is used for burt or kurz danach auftritt. The treatment with a fibrosis of the musk tone is clinically clinical due to the enhanced musk generation and rush. The weight of the disease depends on the pleasure of the disease, the pleasure of self-healing, the beginning of the support of the disease and the disease of a cardiomyopathy. DMD reduces the life support of the atmosphere and/or recovery for their fourteen lives. Short-circuit steroids are the time standard for the treatment of DMD.

Uber Santhera
Santhera Pharmaceuticals (SIX: SANN) is a specialty pharmaceutical company engaged in the development and marketing of innovative drugs for neuromuscular development with a specialty drug. The alternative consists of an exclusive Lizenz von ReveraGen for all indications for AGAMREE® (Vamorolon), a dissoziative steroid with new artificial intelligence, which is being investigated in a certain disease study in patients with Duchenne Muscular Dystrophy (DMD) as an alternative to standard corticosteroids. AGAMREE for the treatment of DMD is approved in the US by the US-American Food and Drug Administration (FDA), in the EU by the European Arzneimittelbehörde (EMA) and in the United States by the Medicines and Healthcare products Regulatory Agency (MHRA)- zugelassen. Santhera has established an AGAMREE for North America, Catalyst Pharmaceuticals, Inc. and for China and Sperogenix Therapeutics. For more information, please visit www.santhera.de.

AGAMREE® is one of the flagship products of Marke von Santhera Pharmaceuticals.

For more information you can say:
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Eva Kalias, Head of Investor Relations & Communications
Tel.: +41 79 875 27 80
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Haftungsausschluss / Zukunftsgerichtete Aussagen
This Mitteilung again states that there is no information regarding the approval of the Zeichnung or the purchase of Wertpapers from Santhera Pharmaceuticals Holding AG. This publication can bring the best results in the field of economics and the development of the state system. Solche-aussagen are mit de best risks, unsicherheiten und einem faktoren-linken, die sich tatsächlichen ergebnisse, de financing, de leistungen oder errungenschaften des errungenschaften des onternehmens sich er sich es, die in de sollchen-aussagen zum ausdruck were brought or implied. The teachers believe that they are not in trouble with these foreign people, but that they will not have to deal with investments or investment separations in the future. If the device no longer provides light, these targeted programs are intended to be activated.

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