It was all going so well. Less than two months ago positive phase I data with Oxurion's THR-149, a novel plasma kallikrein inhibitor, spurred hopes that the Belgian biotech's transformation could be under way. Those expectations were comprehensively dashed today with the failure of the group's lead pipeline project, THR-317, in diabetic macular oedema.
With disappointing sales from its only marketed product, just €76m ($84m) in the bank and an early-stage pipeline that will need significant funding to move forward, it is hard to see where Oxurion will go next. This uncertainty over the group’s future was mirrored in the 41% slide in Oxurion shares in early trading today.
At least it’s safe…
The phase IIa combination study of THR-317 was always going to be a risk given the project's untested mechanism: inhibition of placental growth factor (PIGF). This novel approach meant that few analysts were willing to forecast future sales for THR-317, implying that today’s share price slide was as much to do with sentiment around Oxurion as it was the trial results. The company last year changed its name from Thrombogenics,
In the 70 patient trial, THR-317 in combination with Lucentis failed to show an improvement over Lucentis alone, with the combination therapy only achieving an increase in best corrected visual acuity (BCVA) of 8.71 letters, versus 8.18 letters for the monotherapy.
However, the combination therapy did show slightly better improvements in BCVA in two patient subgroups that Oxurion said were prespecified: those with poor, or no, response to prior anti-VEGF treatment and those with a low baseline of ≤65 letters. This led some industry observers to speculate that the trial failure might have been down to poor population choice, and question why previous studies had failed to recruit poor responders to VEGF therapies.
Assuming that Oxurion is thinking like a typical small biotech, it will still be searching for a path forward for THR-317. But having suffered a huge commercial disappointment with its sole marketed product, Jetrea - which was also afflicted by a poor choice of patient group - confidence in the group's abilities have got to be pretty low.
Additionally, while the group’s strongest pipeline candidate THR-149 demonstrated impressive phase I results, it is significantly behind a rival project from Kalvista Pharmaceuticals. KVD001 is due to report phase II data by the end of the year.
So with no prospects for fresh income streams in the short term, and competition nipping at the heels of its most innovative candidates, Oxurion needs to do something radical to retain what little investor faith it still has. The obvious solution would be an acquisition, but given its small cash pile this is unlikely to be transformative.
Cutting its losses with THR-317 to save cash would also be a solution; the question here is whether Oxurion will go against the biotech grain and execute such a definitive move.