Biotechnology company BioSenic’s affiliate Medsenic has amended its licence agreement with Australia-based pharmaceutical company Phebra for the oral formulation of arsenic trioxide (OATO).

Medsenic reached licensing, marketing and supply agreements with Phebra for OATO in May 2021.

The formulation is intended for indications, including systemic sclerosis, graft versus host disease, systemic lupus erythematosus 151, central nervous system inflammatory diseases associated with multiple sclerosis and infectious diseases linked to Covid-19.

BioSenic chairman and CEO Professor François Rieger stated: “We are particularly satisfied with the excellent degree of coordination between Phebra and Medsenic, aimed at delivering the clinical batches for entering into the realisation of the expected Phase III trial of the oral medication, related to the previously agreed exclusive licence between Phebra and Medsenic.

“Both recent technical advances for the oral ATO clinical supply and the newly agreed amendment to the original licence will help render possible a quick FDA approval, through a necessary IND submission, followed by the expected activation of centres and patients recruitment.”

The licence agreement is contingent upon Medsenic’s ability to initiate a clinical study before 31 May 2024.

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BioSenic Group and Phebra are also exploring the potential for extending Medsenic’s territories and related commercial terms.