Yesterday, Promore Pharma announced results from its phase 2b study on the treatment of venous leg ulcers, a form of chronic wound. The primary endpoint, complete wound healing, was not met at the aggregate level. Promore reports that complete wound healing was significantly increased in a subgroup, namely, patients with larger wounds (>10cm2). Complete wound healing is also the same endpoint as regulatory authorities would be asking for in a registrational Phase 3 trial. The 0.5mg/ml dose, one of two active dose arms, showed a larger effect size and no serious safety concerns were reported.
We have mixed views of the trial data and future prospects of Ropocamptide. The market for larger wounds has clear potential and demand for new treatments is high. However, as the results were not as expected, we believe that Promore’s business and research plans need to be reviewed. The market understandably reacted negatively to the lack of transparency, causing the stock to plunge 23% yesterday.
Promore’s core strategy for the LL-37 project was to find a partner after the readout of the phase 2b trial. We lower our expectations of such a deal but also conclude that we do not have full visibility into the dataset.
A few comments:
Should Promore decide to continue with Ropocamptide in a phase III study, it will likely be targeting patients with larger wounds, specifically. No detailed plan of how such study might be designed is available as of today, as far as we know. About 20-30% of the patient population have wounds larger than 10 cm2, but the economic burden is much higher in this subgroup, indicating a remaining business potential.
We will provide a more detailed analysis and update our fair value range once we get further visibility into the dataset, but expect to lower our base case following yesterday’s information.
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