Larimar Therapeutics, Inc. (LRMR) stock prices were up by a marginal 1.54% as of the market closing on July 2nd, 2021, bringing the price per share up to USD$9.89 at the end of the trading day. After hours trading saw the stock surge by 10.21%, bringing it up to USD$10.90.
Clinical Hold for CTI-1601
May 25th 2021 saw the company announce that the U.S. Food and Drug Administration had placed a clinical hold on LRMR’s ongoing CTI-1601 clinical program. As a result, the company did not complete its previously announced private placement financing. The clinical trial is for the treatment of patients with FA who are unable to produce enough human frataxin, with CTI-1601 serving is a recombinant fusion protein that is delivered to patients’ mitochondria.
Contextualizing the Hold
The clinical hold came after the company’s reporting to the FDA in regard to mortalities occurring at the highest dose levels in an ongoing 180-day non-human primate toxicology study. The study was designed to support extended CTI-1601 treatment in patients. The FDA implemented the hold in light of needing a full study report from the company’s NHP study, with a restriction on the initiation of additional clinical trials until the report has been submitted and approved by the FDA.
Effects of FDA Decision
The disappointing formal clinical hold notification does not, however, change the company’s previously stated strategy for the clinical development of CTI-1601. LRMR plans to complete its NHP toxicology study, assess the data, and discuss the data with the FDA in order to obtain prior consent for the commencement of their Jive and pediatric MAD trial. Patient safety continues to be a top priority, with the company confident that despite the hiccup, the path forward is still in place.
Deferral of Trials
With the added regulatory requirements associated with the formal clinical hold, the company is entertaining the possibility of deferring the initiation of its clinical trials. The trials are being considered to be pushed up to 2022. Despite the termination of the planned private placement financing, the company reported a solid cash position as of March 31st, 2021. Having reported USD$81.4 million in cash and cash equivalents, the company anticipates being able to fund its operations through to the first half of 2022.
Future Outlook for LRMR
Confident in the timely resolution of the speedbumps in the road towards the commercialization of its treatment candidates, LRMR is poised to continue its trajectory of success. The company is keen to address the FDA’s requirement so it can continue pushing for the development of its various clinical trials.
