Biotech Values

[DewDiligence]

Medivir’s TMC435 produced SVR rates of 75-86% in the phase-2b PILLAR study vs a 65% SVR rate for the SoC arm, which was a statsig outcome:



The above table has the final data from the PILLAR study, which tested two doses and two treatment durations of TMC435 in treatment-naïve genotype-1 patients (i.e. four TMC435 arms and one control arm).

In the above table, the third row (“SVR243”) has the standard SVR metric (24 weeks following the end of treatment). The fourth row (“SVR W724”) is a measurement 72 weeks following the start of treatment, which was either 24 or 48 weeks following the end of treatment; this was the trial’s primary endpoint. * signifies p<0.05; ** signifies p<0.005.

Insofar as relapses more than 24 weeks after the end of treatment are supposedly very rare, it’s surprising that there was a difference of as many as three patients between the third and fourth rows in the above table.

In the aggregate, the two arms with 24 weeks of TMC435 did not fare better than the two arms with TMC435 for only 12 weeks, which is consistent with the findings for Incivek in this genotype-1 population.

Medivir’s full PR on the PILLAR data is at http://finance.yahoo.com/news/Medivir-Announces-Acceptance-bw-1716737682.html?x=0&.v=1 .

TMC435 has already completed enrollment in three phase-3 trials (#msg-66692743); each of these trials has 375 patients and uses a response-guided duration of treatment. See #msg-63363125 for interim TMC435 phase-2b data in the ASPIRE study in the second-line setting.