On Thursday, RAPT Therapeutics Inc. RAPT announced that it has decided to close and unblind both its Phase 2b trial of zelnecirnon (RPT193) in atopic dermatitis (AD) and its Phase 2a trial of zelnecirnon in asthma.
Both clinical trials were placed on clinical hold by the FDA in February 2024 based on a serious adverse event of liver failure requiring a transplant in one patient in the AD trial.
Before the clinical hold was imposed, 229 patients had been enrolled in the Phase 2b AD trial, of which approximately 110 had completed the 16-week dosing period.
“Although there were a significant number of patients who were unable to complete the AD trial due to the hold, we believe we will have sufficient data, even if not statistically significant, to inform our path forward and support our discussions with the FDA,” said Brian Wong, President and CEO.
“We are working with the clinical trial sites to clean the data, and we anticipate that our analysis of the data will be completed in the third quarter of this year. Concurrently, we are continuing our investigation and analysis of the serious adverse event that triggered the clinical hold,” the company added.
The company reported first-quarter net loss of 2024 was $30.5 million, compared to $29.3 million for the first quarter of 2023.
As of March 31, 2024, the company had cash and cash equivalents and marketable securities of $141.6 million.
Price Action: RAPT shares are down 42.60% at $4.58 at last check Thursday.
Photo by Louis Reed via Unsplash
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