Re: Median treatment duration in RNVC’s BELMONT trial in glabellar lines
According to my model of the BELMONT trial, the median duration of the 40U* dose of RVNC’s RT002 is longer than the median duration of 20U of Botox by about 3 weeks: 4.7 months for RT002 vs 4.0 months for Botox.
Here’s how I arrived at the 4.7-month figure:
1. The median duration of effect in the RT002 40U arm as reported by RVNC was 23.8 weeks.
2. RVNC did not report the median duration of effect in the (highest dose) 60U arm. Inasmuch as RVNC would have had a strong incentive to report the median duration in the 60U arm if it had been longer than the median duration in the 40U arm, it’s reasonable to surmise that the median duration in the 60U arm was shorter than the median in the 40U arm. We don’t know how much shorter the median in the 60U arm was, so my model arbitrarily uses a figure of 20.2 weeks.
3. There is no scientific reason I know of for an inverted dose response for RT002 in this indication, so it’s reasonable to presume that the shorter median duration of effect in the 60U arm compared to the 40U arm was due to chance. In that case, the average of the 40U and 60U arms is a less biased estimate of the true underlying median duration of a 40U dose of RT002 than the observed median in the 40U trial arm. The average of 23.8 weeks and 20.2 weeks is 22.0 weeks.
4. The BELMONT trial had a 4-week interval between follow-up examinations. Thus, when a patient was recorded as having regressed to baseline during a given follow-up exam, the actual regression to baseline would have occurred 2 weeks earlier (half the interval between exams) on average. Hence, my model reduces the 22.0-week figure in paragraph #3 above to 20.0 weeks to eliminate the bias caused by the interval between follow-up exams.
5. 20 weeks = 140 days = 4.7 months.
*RVNC has selected 40U as the dose to advance to phase-3 trials in the glabellar-lines indication.
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