Imara Inc (NASDAQ: IMRA) shares took a thrashing Wednesday following the release of mid-stage results of its IMR-687 in sickle cell disease.
Underwhelming Data: IMR-687 failed to close part of the gap from the 1.7% absolute increase in fetal hemoglobin, or HbF, demonstrated at interim readout and the 3% responder threshold agreed to by the FDA as a potential surrogate endpoint in sickle cell disease studies.
In the monotherapy arm, a dose-dependent increase of 1.3% in HbF was seen when dose escalated from 100 mg to 200 mg, starting after four weeks and through 24 weeks, as revealed by biomarker results.
The results were worse in the combination arm, which evaluated IMR-687, once-daily at 50 mg, on top of a stable dose of standard of care, hydroxyurea.
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Weakness A Potential Buying Opportunity: The top-line results are not a good indicator of future IMR-687 data due in 2021 due to two reasons, SVB Leerink analyst Joseph Schwartz said. COVID-19 impacted the Phase 2a trial significantly with numerous missed visits and potentially undermined the quality of data at the visits that did occur, the analyst said.
Additionally, drug exposure and doses examined in the Phase 2a study were much lower than the doses contemplated moving forward in the Phase 2a open label expansion study and the Phase 2b study, Schwartz said.
“Therefore, we see the stock’s weakness on the news as a potential buying opportunity ahead of IMRA’s multiple data readouts in 2021,” the analyst wrote in the note.
SVB Leerink has an Outperform rating on Imara shares.
IMRA Price Action: Imara shares closed down 37.9% at $14.72.
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|Jun 2020||SVB Leerink||Maintains||Outperform|
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