Almirall has signed an exclusive licence agreement to gain worldwide rights for Eloxx Pharmaceuticals’ ZKN-013 for rare dermatological disease indications.

Almirall will develop and market the drug candidate. The exclusive licensing deal includes the development of the asset for orphan skin conditions.

The oral nonsense mutation readthrough drug is designed to enable the production of functional proteins by host cells that address the underlying causes of these conditions.

ZKN-013 is set to enter Phase I trials in healthy volunteers in the coming months of 2024.

Eloxx is entitled to receive an upfront payment of $3m from Almirall and milestone payments up to $470m on meeting developmental, regulatory and sales-based goals, except for royalties on future global product sales.

Almirall research and development (R&D) executive vice-president and chief scientific officer Karl Ziegelbauer stated: “This licence agreement is aligned with Almirall’s R&D strategy to develop novel treatments to help people with dermatological conditions, including rare diseases.

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“We look forward to progressing the development of ZKN-013 to find a potentially impactful solution for patients suffering from rare and devastating diseases caused by nonsense mutations.”

Rare skin diseases such as recessive dystrophic epidermolysis bullosa and junctional epidermolysis bullosa are characterised by defects in the Collagen7 gene, crucial for skin structure and barrier function.

In addition to dermatological applications, ZKN-013 is being developed for familial adenomatous polyposis patients with nonsense mutations, a rare gastrointestinal disease.

Eloxx Pharmaceuticals president and CEO Sumit Aggarwal stated: “We are very excited about this agreement with Almirall to develop and distribute ZKN-013, our lead TURBO-ZM-based molecule, as we believe it has the potential to have a significant impact on the treatment of these painful and debilitating diseases.”

Last month, Almirall signed an exclusive licensing agreement for Novo Nordisk’s interleukin-21-hindering monoclonal antibody, NN-8828.