During our clinical trials analysis webinar last week, I warned investors to be wary of biotechs that claim to have “positive” clinical trial results in the headline of their press release as a means to bury the bad news below.
That’s exactly what the Seattle biotech Omeros did Monday.
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First of all, the so called “placebo” is not a real placebo. Patients are in very bad condition and they were treated with RAS blockade in the placebo group.
Omeros CEO explained very clearly in his presentation about the trial results:
1) 18% reduction during the first 12 weeks from placebo (i.e. RAS blockade) is consistent with finding from other studies. But its treatment effect can not last long.
2) There is big difference between the treatment group and the placebo group in IgaN disease time (with median of 19 years for treatment vs median of 9 years for placebo) and patient age (with median of 50 years for treatment vs 33 years in placebo). Since those patients in the treatment group have IgaN for such a long history (and much longer history than placebo), their disease condition is much worse thus more treatment time is needed to achieve stable treatment effect. 18.4% reduction in treatment group for 12 weeks (a cycle) is a good treatment effect considering such a bad disease condition.
3) However, after all the patients from both treatment and placebo groups had an extension of 6 weeks treatment with OMS721, the median reduction is > 50%! This is amazing! It is also consistent with Cohort 1. Thinking about the patients’ disease history of only 2-5 years in Cohort 1, Omeros and the experts were excited with the new (and stronger) data! It is never seen such a great treatment effect in the natural history of IgaN!
4) In the Phase 3 study, Omeros had already considered the treatment time. The primary endpoint is for 24 weeks (2 cycles).
so Vernon Bernardino just left Seaport – where’s he headed ?
Dear Adam, you like easy wins
fun fact:
the company’s CSO published an article as first author in the prestigious journal Cell. Too bad it was retracted a couple of years later! Which should mean you are either a really bad scientist or a cheater, … or both.
And if, a “commercial-stage biopharmaceutical company” doesn’t commercialize any product in 24 years, maybe there is a reason.
dipthroat, your comment is very cryptic. I read it as a criticism of the article but not sure. Do you think OMER’s results of over 50% efficacy for periods longer than 12 weeks was a positive?
It’s too bad that you actually didn’t read or understand the study. The three excluded subjects were excluded based on considerations other than the drug, and never in fact received any treatment with it. In addition, the long term affects of the drug we’re remarkable. With four patients exhibiting above 50% reduction. Also, most Analysts I follow state whether they have a position, long or short in the stock. The fact that you don’t do this leads me to believe that you are not an analyst.
Adam,
What you mention here is extremely valid. Couple questions.
1) What’s your thoughts on the results of the extension of the initial 12 week study, where the patients showed a drop of moer than 50% in the proteinuria levels.
2) As a follow up to #1, one of the outcomes could also be that the effect of OMS-721 is prominent only after say 16 or 20 weeks. Any thoughts on this?
3) The article on the Omeros website also mentions the OMS-721 results to be very similar to the results from steroid treatment. By way of equivalency, does that mean steroids have similar effects as placebos?
Thanks much!
You didn’t discuss the over 50% improvement over the next 12 weeks. Why is this invalid? After nearly dying from kidney failure my vitals took over 6 weeks to turn positive. Are you so anxious to kill companies who might help people?