RARE Daily

Sanofi Terminates Alport Syndrome Collaboration with Regulus

January 9, 2023

Regulus Therapeutics said Sanofi is terminating its collaboration and license agreement that dates back to 2014 focused on Alport syndrome, the company said in a filing with the U.S. Securities and Exchange Commission.

In July, Sanofi had ended the phase 2 clinical study of lademirsen for the treatment of Alport syndrome for failure to meet Sanofi’s pre-defined futility criteria. Regulus was notified at that time that Sanofi was evaluating other opportunities for the program in other indications and according to Sanofi, Regulus said the decision to terminate the study did not stem from any safety issues.

In accordance with the agreement, the termination will become effective on February 5, 2023, which is 30 days following the date of delivery of the notice by Sanofi.

Under the terms of the agreement, Regulus had granted Sanofi a worldwide, royalty-free, fee-bearing, exclusive license, with the right to grant sublicenses to develop and commercialize miR-21 compounds and products for all indications, including Alport Syndrome. Sanofi assumed all responsibilities and obligations for developing and commercializing each of Regulus’s miR-21 programs, including lademirsen for the treatment of Alport Syndrome.

Lademirsen was the only product candidate from the collaboration advanced against miR-21 into the clinic. In addition, under the agreement Sanofi had opt-in rights to Regulus’s preclinical program targeting miR-221/222 for oncology indications.

Author: Rare Daily Staff

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