PIPER SUGGESTS ATHX GO FORWARD WITH CHUGIA
PIPER $ATHX Athersys released top-line data from the Phase II MultiStem stroke trial this morning.
The study missed both the primary endpoint of global stroke recovery and the secondary
endpoints of performance on the individual components. Interestingly when the analysis
was restricted to those patients receiving MultiStem within 36 hours (n=27), response
was substantially improved on the primary endpoint (Odds Ratio 2.21, p=0.07) and
the proportion of patients achieving an "excellent outcome" (p=0.03). As a result, we
see the opportunity for Athersys and Japanese partner Chugai to continue to develop
MultiStem in stroke. Including the Chugai upfront, we estimate we estimate Athersys
holds proforma cash of $36 million, so will likely need to raise additional capital. We
maintain our Overweight rating, but are cutting our price target to $2 from $4.
• MultiStem Misses. MultiStem was safe and well-tolerated, however did not show a
benefit vs. placebo at day 90 in either the primary composite endpoint of global stroke
recovery or on the individual components. We are not surprised by this outcome
because the hurdle for success was very high. That said, 15.4% of MultiStem treated
patients achieved an Excellent Outcome (mRS 0-1, NIHSS 0-1 and BI =95) compared
to only 6.6% of patients on placebo (p=0.10). Further MultiStem treatment was
associated with lower mortality and life threatening AEs (p=0.04). MultiStem also
lowered circulating T-cells 2 days after dosing (p<0.01), indicating reduction of postevent
inflammation. The data will be presented at the European Stroke Organization
(ESO) Conference in Glasgow on Sunday, April 19 at 8:50am local time.
• Time to Treatment Still Meaningful? Current gold standard tPA is only available for
patients who are treated 3-4 hours after the stroke, severely restricting the treatment
pool to ~5% of patients. Athersys enrolled 126 ischemic stroke patients to receive a
single IV dose of MultiStem or placebo within 24-48 hours after the event (average
30-34 hours in trial). In a post-hoc sub-group analysis, patients treated within 36
hours saw non-significant improvements in response on both global stroke assessment
(Odds Ratio=2.21, p=0.07) and the proportion of patients achieving an excellent
outcome (18.5% vs. 1.9%, p=0.03). This sub-group also excluded patients who
received both tPA and mechanical re-perfusion. This subgroup had less than half the
initial MultiStem cohort (27/65) severely limiting power. This analysis indicates that
MultiStem may still increase the therapeutic window for stroke patients ineligible for
tPA, however more studies will need to be conducted to confirm this effect.
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