RAPT Therapeutics Halts Zelnecirnon Trials in Atopic Dermatitis and Asthma Following FDA Clinical Hold
Key Insights
RAPT Therapeutics has decided to close and unblind its Phase 2b trial of zelnecirnon in atopic dermatitis (search) and its Phase 2a trial in asthma (search) after an FDA clinical hold.
The clinical hold was initiated due to a serious adverse event of liver failure requiring a transplant in one patient during the atopic dermatitis (search) trial.
RAPT Therapeutics plans to analyze the data collected from the trials, even if not statistically significant, to inform future steps and discussions with the FDA.
RAPT Therapeutics Inc. (NASDAQ:RAPT) announced the cessation of its Phase 2b trial of zelnecirnon (RPT193) in atopic dermatitis (search) (AD) and its Phase 2a trial of zelnecirnon in asthma (search). The decision follows a clinical hold placed by the FDA in February 2024 due to a serious adverse event. The event involved liver failure requiring a transplant in a patient participating in the atopic dermatitis trial, impacting the company's clinical development program.
Clinical Trial Status and Data Analysis
Prior to the clinical hold, the Phase 2b atopic dermatitis (search) trial had enrolled 229 patients, with approximately 110 completing the 16-week dosing period. Brian Wong, President and CEO of RAPT Therapeutics, stated, “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.”
The company is currently working with clinical trial sites to clean the data and anticipates completing the analysis in the third quarter of this year. RAPT Therapeutics is also continuing its investigation into the serious adverse event that triggered the clinical hold to fully understand the cause and potential implications.
Financial Position
RAPT Therapeutics reported a first-quarter net loss of $30.5 million for 2024, compared to $29.3 million for the first quarter of 2023. As of March 31, 2024, the company's financial resources included $141.6 million in cash, cash equivalents, and marketable securities. This financial position will be crucial as the company navigates the next steps in its clinical development programs following the trial halts.
Impact on RAPT Therapeutics Stock
The announcement has significantly impacted RAPT Therapeutics' stock, with shares down 42.60% at $4.58 at last check Thursday.