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Posted On: 09/28/2020 2:45:36 PM
Post# of 153832
While I'm loathe to post on another drug's success, the 9/24 release from OncoImmune can teach us a lot. Their DSMC closed this trial for efficacy at about 75% enrollment.
First, I'll mention that, looking at its MOA, Ohm noted that if this drug works, leronlimab should work in even better.
Basically their Phase III trial is using the same 7-category scale we have as a secondary endpoint. To be admitted, you have to be a 3 or 4 on that scale - getting oxygen but not intubated. "Clinical recovery" is defined as moving to a "2" score (hospitalized, no oxygen), progression was moving to a "5" (requiring intubation).
They claimed 60% increase in patients hitting clinical recovery (significant at p=.005) and a 50% reduction in patients progressing (not claimed as significant). So,
(1) Based on NEWS2 and SAEs, it sounds like our Phase 2 would have done similarly or better on comparable patient pop,
(2) on Phase 3, we can recreate exactly their results for our data for an apple-to-apples comparison,
(3) this interim was specified not by the number of patients, but by the number of recoveries, nice,
(4) we now know what results can cause a stopped trial,
(5) this drug is competition, but not for the trial of the sickest,
(6) OncoImmune also wrote a lousy press release IMO - my headline should have been: "OncoImmune in COVID 19 - Phase 3 trial halted for efficacy: Stat significant 60% increase in patients improving, 50% reduction in progressions,"
(7) Biospace noted the press release but has not otherwise commented in its news stream.
First, I'll mention that, looking at its MOA, Ohm noted that if this drug works, leronlimab should work in even better.
Basically their Phase III trial is using the same 7-category scale we have as a secondary endpoint. To be admitted, you have to be a 3 or 4 on that scale - getting oxygen but not intubated. "Clinical recovery" is defined as moving to a "2" score (hospitalized, no oxygen), progression was moving to a "5" (requiring intubation).
They claimed 60% increase in patients hitting clinical recovery (significant at p=.005) and a 50% reduction in patients progressing (not claimed as significant). So,
(1) Based on NEWS2 and SAEs, it sounds like our Phase 2 would have done similarly or better on comparable patient pop,
(2) on Phase 3, we can recreate exactly their results for our data for an apple-to-apples comparison,
(3) this interim was specified not by the number of patients, but by the number of recoveries, nice,
(4) we now know what results can cause a stopped trial,
(5) this drug is competition, but not for the trial of the sickest,
(6) OncoImmune also wrote a lousy press release IMO - my headline should have been: "OncoImmune in COVID 19 - Phase 3 trial halted for efficacy: Stat significant 60% increase in patients improving, 50% reduction in progressions,"
(7) Biospace noted the press release but has not otherwise commented in its news stream.
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