BioXcel trades lower after mixed results for lower dose Igalmi for bipolar agitation
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BioXcel Therapeutics (NASDAQ:BTAI) said the main efficacy goal was not statistically significant at 2 hours for its drug BXCL501 versus placebo in Part 1 of a phase 3 trial for acute treatment of bipolar disorders- or schizophrenia-associated agitation in an at-home setting.
Part 1 of the phase 3 study, dubbed SERENITY, evaluated BXCL501 — which is half (60mcg) of the approved 120 mcg dose of Igalmi — (n=101) versus placebo (n=100).
The company said clinically meaningful efficacy results were seen with the 60mcg dose. Greater than 50% PEC response rate was achieved, with responder rate dose-proportionally consistent with those seen in SERENITY I and II studies.
For the main goal, at 2 hours post-dose, the change in PEC differed from placebo, but did not reach statistical significance, (p-value of 0.077).
However, BXCL501 separated from placebo at 4 hours (p=0.049), the company added.
BioXcel noted that the proportion responding was greater than with placebo as early as 1 hour (p = 0.035) and remained so through 4 hours.
"We chose half of the lowest approved IGALMI dose, 60mcg, with the goal of increasing the margin of safety while supporting efficacy for at-home use," said Robert Risinger, chief medical officer, Neuroscience, BioXcel.
The 60mcg dose was well tolerated and there were no serious adverse events. All adverse events were reported as mild to moderate, according to the company.
BioXcel said data shows favorable safety results relative to those seen in studies evaluating the higher approved doses (120mcg and 180mcg).
The company noted that the data provides a path for starting SERENITY III Part 2, to pursue approval in the at-home setting.
"This would potentially more than double our current market opportunity, if approved," said BioXcel CEO Vimal Mehta.
BTAI -3.59% to $25 premarket May 25