SeaBeLife, accompagnée par Angels Santé, Les Business Angels des Grandes Ecoles, Investessor et la coordination régionale Breizh Angels, annonce des résultats précliniques très prometteurs pour SBL03, un gel ophtalmique non invasif visant à protéger la rétine dans la DMLA sèche.
SeaBeLife, société de biotechnologie qui développe des candidats médicaments innovants destinés à bloquer la nécrose cellulaire, annonce aujourd’hui des résultats in vivo significatifs pour son candidat médicament SBL03, un gel ophtalmique innovant pour lutter contre la mort nécrotique des cellules rétiniennes dans l’atrophie géographique (AG), une forme avancée de DMLA sèche (dégénérescence maculaire liée à l’âge).
Ces données peuvent être considérées comme une avancée majeure dans un parcours à enjeux élevés visant à apporter une solution aux millions de patients confrontés à une perte irréversible de la vue, pour lesquels il n’existe aucun traitement disponible en Europe. L’objectif principal de l’étude était d’évaluer l’efficacité du candidat médicament SBL03 dans un modèle préclinique in vivo de dégénérescence rétinienne induite. Il s’agissait de confirmer le potentiel thérapeutique de SBL03 dans le traitement de l’atrophie géographique, une forme sévère de dégénérescence maculaire liée à l’âge (DMLA sèche) à l’aide d’une solution innovante, non invasive et bien tolérée.
SBL03 est un double inhibiteur de la mort cellulaire nécrotique régulée. Il est formulé sous forme de gel ophtalmique pour administration topique sous forme de collyre et est donc non invasif. Cette solution permettrait d’éviter aux patients de subir une perte de la vue liée à la dégénérescence rétinienne, en ciblant directement les cellules affectées par la maladie, quelle que soit son origine.
L’efficacité de SBL03, formulation de gel ophtalmique, a été évaluée à l’aide d’un modèle animal préclinique reproduisant les principales caractéristiques cliniques de l’atrophie géographique observées chez les patients. Il s’agit notamment de la dégénérescence de l’épithélium pigmentaire rétinien, entraînant une perte progressive et irréversible des cellules photoréceptrices responsables de la vue. Après l’induction de la dégénérescence rétinienne, les modèles précliniques ont été traités par des instillations topiques répétées de SBL03 sur plusieurs jours.
Les effets thérapeutiques ont été évalués à l’aide d’analyses fonctionnelles et structurelles in vivo (électrorétinographie – ERG ; tomographie par cohérence optique – OCT ; autofluorescence du fond d’œil – FAF), ainsi que de tests histologiques quantitatifs post-mortem. Les données mettent en évidence la capacité du SBL03 à s’infiltrer dans les différentes parties de l’œil et à atteindre son tissu cible, la rétine, en concentration adéquate. L’analyse a révélé que les yeux traités par SBL03 présentent une protection significative de l’intégrité structurelle et fonctionnelle de la rétine. Les différents paramètres examinés ont été corrélés et montrent qu’un traitement oculaire topique répété avec SBL03 a un effet protecteur contre la dégénérescence rétinienne par rapport au placebo.
« Les résultats précliniques obtenus avec SBL03 sont très prometteurs et ouvrent de nouvelles opportunités dans le traitement des troubles dégénératifs de la rétine. La combinaison d’une action ciblée et d’une administration topique en fait une solution particulièrement prometteuse pour préserver la vue des patients et donc leur qualité de vie », a déclaré le Pr Jean-François Korobelnik, professeur d’ophtalmologie au CHU de Bordeaux, France.
« Par rapport aux traitements actuels, disponibles uniquement aux États-Unis, notamment les injections intravitréennes, la méthode d’administration topique utilisée pour SBL03 pourrait améliorer considérablement le confort et l’observance du traitement des patients pour cette maladie chronique, qui nécessite un traitement à vie. Cela constituerait une alternative prometteuse qui pourrait transformer la prise en charge des patients qui n’ont actuellement pas d’option de traitement satisfaisante ou bien tolérée », a déclaré Morgane Rousselot, PhD, PDG et cofondatrice de SeaBeLife.
« Avec le tour de financement de série A que nous préparons actuellement, nous pourrons poursuivre le développement du SBL03 dans le traitement de cette maladie qui touche des millions de personnes dans le monde entier. » À ce jour, SeaBeLife est la seule entreprise à avoir développé une solution thérapeutique à administration topique contenant un inhibiteur régulé de la mort cellulaire nécrotique pour traiter l’atrophie géographique. Cela positionne le SBL03 comme une innovation de rupture.
SeaBeLife prévoit d’accélérer le développement du SBL03 en introduisant un processus de production standard. Les études précliniques réglementaires devraient débuter en 2025, avec pour objectif de réaliser un premier essai clinique chez l’homme en 2026. L’atrophie géographique est une forme sévère et avancée de DMLA sèche (ou atrophique) qui se caractérise par une perte progressive et irréversible de la vue. Cette maladie résulte de la destruction des photorécepteurs et des cellules de l’épithélium pigmentaire rétinien ; elle touche 5 millions de personnes dans le monde. En raison du vieillissement de la population, ce chiffre devrait atteindre 10 millions d’ici 2040. En Europe comme aux États-Unis, elle est la principale cause de cécité chez les patients de plus de 50 ans. Actuellement, il n’existe aucun médicament ni traitement disponible en Europe pour la DMLA sèche.
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