FDA Clears High Dose Cohort of CTI-1601, SOMNUM AI Device Approved, Intracranial Pressure Monitoring and TBI

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Welcome to this special edition of Neurology News Network. I’m Marco Meglio.

After the company released positive phase 2 data earlier this year, Larimar Therapeutics announced that the FDA has cleared a 4-week, placebo-controlled exploration trial assessing its investigational Friedrich ataxia (FA) agent CTI-1601 in doses of 50 mg. The company’s open-label extension (OLE), which will assess 25 mg of CTI-1601 daily, was also cleared for initiation by the FDA. In the exploration trial, ambulatory and nonambulatory individuals with FA aged at least 18 years old will be randomly assigned 2:1 to either CTI-1601 or placebo daily via subcutaneous injections for the first 14 days, and then every other day until day 28. The trial features 2 cohorts, a 25 mg and 50 mg dosed group. Cohort 1, assessing a 25 mg dose of CTI-1601, includes 13 participants (9 on active treatment, 4 on placebo) while Cohort 2, which is initiating, will include 12-15 participants randomized to either CTI-1601 or placebo in 50 mg dose settings.

The FDA recently approved HoneyNaps’ SOMNUM artificial intelligence (AI) sleep disease analysis algorithm, the first AI solution designed for diagnosing sleep disorders. SOMNUM, supported by eXplainable Medical AI technology, utilizes deep learning-based AI to conduct a real-time analysis of vast volumes of multi-channel/time series biosignals. The technology is believed to surpass conventional video image reading systems for biosignals, according to the company. HoneyNaps also noted that this technology is setting a new standard for accuracy and transparency in the field. Ji Ho Choi, head of the center for sleep medicine at Soonchunhyang University Hospital in Korea, said in a statement that, “with the continuous improvement of biosignals AI reading technology, it will be possible to detect or predict some cardiovascular, neurological, and muscular diseases beyond the diagnosis of sleep disorders.”

Recently published findings from the CREATIVE prospective cohort trial showed a significant association between intracranial pressure (ICP) monitoring and worse patient outcomes among individuals with traumatic brain injury who met the guidelines for such intervention. Patients on ICP monitoring also showed more frequent use of medical interventions and their significant adverse events, which may have played a role into worse outcomes. Published in Jama Network Open, the 5-year analysis included 1448 patients with TBI from 43 intensive care units in Italy and Hungary, 504 (34.7%) of which underwent ICP monitoring (median age, 45 years) within the first 2 days of their injury. Only patients with TBI who met the Brain Trauma Foundation guidelines for ICP monitoring were selected for the analyses, which were performed from January to November 2022. The study specifically used changes in the Glasgow Outcome Scale Extended (GOS-E) score to assess functional disability.

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