This was GS's reaction to the pr on pralnacasan. As in VRTX's pr itself), GS shows that, beyond saying that the results of the trial appear not to have been robust, it is about as much in the dark as anyone. What caught my eye in the pr was: Aventis will evaluate the timing of initiating such trials.
snip:
This morning, Vertex and Aventis announced their intent to proceed with
additional clinical trials of pralnacasan for rheumatoid arthritis (RA), as
well as additional indications, including osteoarthritis, based on results
of a European Phase II study. Although we do not have all the details, the
data that was reported suggest that pralnacasan had some efficacy, but the
results were not robust. This was the first large Phase II study that had
been conducted and we believe there is more still to learn, particularly
with respect to optimal dosing. It is not clear yet what the next clinical
studies will be. We think it would be logical to do additional dose finding
studies before proceeding to Phase III. Although we don't know when we will
get more clarity on likely next steps, it is possible that Aventis will
provide more detail at their analyst meeting June 18-19.
The stock has traded off sharply on the news. We believe that in the $28-30
range, expectations had been for more robust results and faster possible
progression to Phase III. However, this was the first large Phase II study
that the companies conducted, and prior to these results there was little
data from which to make inferences about likely efficacy or safety. We
regard the fact that both companies plan to proceed with development as a
positive. If successfully developed, pralnacasan could address a market
opportunity of over $1 billion. Unlike other biologicals, pralnacasan is an
oral agent, and could potentially address a broader patient population.
However, it will take time to develop the compound.
quid |
