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Leo’s Congenital Ichthyosis Candidate Fails Phase III Study

Drug Acquired In Timber Purchase

 
• By Joseph Haas

TMB-001, a topical formulation of isotretinoin, missed its primary endpoint in the ASCEND study and will not be filed for approval. Leo is turning its attention to hand eczema and dealmaking.

topical medication
Leo hoped to develop a topical as the first drug therapy for congenital ichthyosis • Source: Shutterstock

LEO Pharma A/S is not saying for certain that it has closed the door on its ointment formulation of isotretinoin, but said on 21 August the failure of TMB-001 to hit the primary endpoint in a Phase III study in congenital ichthyosis means it will not file a new drug application seeking the first approved therapy in the orphan dermatologic disease.

Key Takeaways

  • Leo’s topical isotretinoin formulation for congenital ichthyosis missed its primary endpoint in a Phase III study and will not be filed for US approval.

Brian Hilberdink, North America EVP for the Denmark-based dermatology firm, told Scrip that no final decision has been made on...

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