554-001 - Communiqué du Président sur l'entrée en Phase 2

Communiqué de notre président, Dr Gaëtan Terrasse, de la possibilité d’entrer directement en Phase 2 pour le produit 554-001, après avis des autorités belges (AFMPS). 

« I am pleased to inform you that the company H4 Orphan Pharma met with the Belgian drug agency on September 12 in Brussels.
The agency authorizes us to go directly into clinical phase 2 for idiopathic pulmonary fibrosis. This is excellent news for our company, but also for all H4O employees and associates who contributed to this success.
I wanted to congratulate Catherine BUR, our pharmacist director of development, who led this project very effectively.
We are now entering a very active phase of our development.
Pulmonary fibrosis is a rapidly fatal disease, with a median survival of 2 to 3 years, with no effective treatment on the market. The 2 drugs on the market only slow down the deterioration of the respiratory state, with many side effects.
Pulmonary fibrosis is increasing sharply, due to long COVID. According to experts, this market will soon be between 20 and 30 billion dollars.
We believe that our drug could significantly improve patient survival in idiopathic pulmonary fibrosis, with very few side effects. This is a real opportunity for our future patients.
Our results in animals showed a complete regression of fibrosis.
In humans, a retrospective study in asthma and COPD showed a very significant improvement in respiratory function over 12 months (more than 20% improvement in FEV1).
A team of Belgian clinicians at the Erasme hospital in Brussels has already accepted the principle of being investigators in our clinical study.
We are pleasantly surprised by the welcome from the Belgian authorities, who tell us that they will help us with further development in IPF as the results of our product on respiratory function are astonishing.
We hope that we will soon be able to share our clinical advances with you.


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