Shut in syndrome trial#

The California-based company remains eligible for other milestones from completion of a Phase II fibrosis proof of concept study, Regulus said in its filing. If the HERA study were completed, Regulus would have gained $25 million from a milestone payment.

Sanofi gained controlof lademirsen’s development in 2018 following a restructuring of a collaboration agreement between the two companies. In the filing, Regulus said the termination was due to the trial’s “failure to meet Sanofi’s pre-defined futility criteria,” but did not elaborate further. Results were expected in the second half of 2023.

Shut in syndrome trial#

The trial was designed to assess the safety and efficacy of the experimental drug. In February, Regulus announced that the Phase II HERA study for Alport syndrome had completed enrollment. Sanofi indicated that it intends to evaluate different opportunities for lademirsen. Securities and Exchange Commission, Regulus said Sanofi has opted to terminate the Phase II clinical development of lademirsen (previously known as RG-012) for the treatment of Alport syndrome, a genetic disease that causes kidneys to progressively lose the ability to filter waste products from the blood. Shares of Regulus Therapeuticsplunged nearly 10% Monday after the company disclosed that its partner Sanofihas terminated a development agreement for a small RNA molecule inhibitor being developed for Alport syndrome.