Biotech Values

[DewDiligence]

Re: MCUR’s unorthodox futility analysis for VLU trial

MCUR’s phase-3 trial in diabetic venous leg ulcers (https://www.clinicaltrials.gov/ct2/show/NCT02130310 ) has a planned interim/futility analysis when 60% of the total patients in the trial have been treated. This will occur before the end of August, according to today’s 2Q15 CC.

What’s unorthodox about this futility analysis is that the DSMB will divulge one of three things to the company (which will also be reported to investors by PR):

1. Probability of success = 0-30%;
2. Probability of success = 31-45%; or
3. Probability of success = 46% or more.

In case #1, the DSMB will presumably recommend that the trial be halted. In case #2, the DSMB might recommend upsizing the enrollment, although upsizing hasn’t been pre-specified in the protocol.

Even in the best case (>=46% probability of success), the range is so wide that it probably won’t be perceived as especially bullish by investors.

p.s. MCUR’s other phase-3 trial, which is in diabetic foot ulcers (https://www.clinicaltrials.gov/ct2/show/NCT01421966 ), is due to report final data in Oct 2015 (contrary to what is says in the aforementioned link).