Larimar Therapeutics, Inc. (NASDAQ: LRMR) has reported that the U.S. FDA has placed a clinical hold on the CTI-1601 clinical program and the company will not close its previously announced private placement financing. The clinical hold comes after the reported mortalities that occurred at highest dose levels in a 180-day non-human primate toxicology study. This study was designed to support extended dosing of patients with CTI-1601. In the clinical hold statement by the FDA, the FDA said that it requires a full study report from the ongoing NHP study and Larimar may not incur additional clinical trials until the company submits the report and receives notification from the agency that additional clinical trials may commence.
“While the notification of a formal clinical hold is disappointing, it does not change our previously stated clinical development strategy for CTI-1601,” said Carole Ben-Maimon, MD, President and Chief Executive Officer of Larimar. “Patient safety is our top priority, and we will continue with our plan to complete the NHP toxicology study, assess the data, and discuss that data with FDA to obtain their consent prior to initiating our Jive and pediatric MAD trials. Based on all of the information we have regarding CTI-1601’s safety profile to date, we continue to believe there is a path forward toward the initiation of our Jive and pediatric MAD trials. However, due to the additional regulatory requirements that come with responding to a formal clinical hold, we believe there is a possibility that the initiation of these trials may be delayed into 2022. Regarding the termination of the previously announced private placement financing, as of March 31, 2021, we have $81.4 million in cash and investments, which provides cash runway through the first half of 2022.”