Clinical-stage biotech Clene Inc. ( NASDAQ: CLNN ) dropped ~14% in the pre-market Monday after the company announced data for its lead candidate CNM-Au8 from a Phase 2 trial involving patients with relapsing-remitting multiple sclerosis (RRMS).
The VISIONARY-MS trial came to a halt in February due to COVID-19 concerns limiting its enrollment to 73 patients out of the 150 planned subjects.
Due to limited enrollment, the investigators pre-specified the threshold for significance at p=0.10 before the database lock, and the primary analysis on the modified intent to treat (mITT) population excluded data from a single site (n=9).
"The ITT results were directionally consistent with the mITT results, although the ITT results were not significant," the company said.
The topline data from the study indicated that LCLA letter change in the clinically affected eye, the trial's primary outcome, indicated 3.13 of least squares mean difference with a p-value of 0.056.
In terms of safety data, the trial demonstrated that the study drug was well tolerated with no significant safety findings, according to the company.
Clene ( CLNN ) notes that the data support CNM-Au8's advancement into Phase 3 development.
In July, the company shares surged in response to data from a long-term open-label extension trial for CNM-Au8 in amyotrophic lateral sclerosis.
For further details see:
Clene falls 14% after Phase 2 data for lead drug in multiple sclerosis