Cassiopea seizes control of PhII trial after partner folds midstudy, delaying data

Cassiopea (SWX:SKIN) has taken control of a Phase II trial after the Israeli biotech it licensed the drug from shut down midstudy. The difficulties mean the genital wart trial has enrolled 27 patients almost three years after the protocol was filed with, a situation that has forced Cassiopea to step in to prevent further delays to the study.

Cosmo Pharmaceuticals (SWX:COPN), Cassiopea’s parent company, picked up the rights to the genital wart drug CB-06-02 from Israeli biotech BioMas in 2014. That agreement gave BioMas responsibility for wrapping up a Phase II proof-of-concept trial designed to show whether CB-06-02, an asset based on the rare element tellurium, could decrease the number of warts and size of the infected area by supporting the body’s immune response against the human papillomavirus.

Originally, BioMas hoped to complete the trial by the end of 2014. That target has slipped repeatedly since then. Now, Cassiopea has confirmed that BioMas has ceased operations, causing further delays to the study. Cassiopea has taken control of the trial and is claiming it is back on track. That track is a lot longer than it once was, though. Until recently, Cassiopea was still claiming data were due in the first half of 2016. The company now says it is unlikely to have the results until the second half of 2017.

The delay was one of two setbacks disclosed by Cassiopea in its half-year report. The other, less severe, delay relates to a Phase II proof-of-concept trial of acne treatment CB-06-01. Having told investors to expect data in the first half of 2016, Cassiopea has now pushed back the forecasted date of the readout to next month. Cassiopea will use the data as the basis for a go/no-go decision that it expects to take by the end of the year.

While the delays represent blows to the two affected programs, they could prove to be relatively minor events for the company as a whole. The top priority for Cassiopea is Winlevi, an antiandrogen acne drug that is in Phase III. With one-third of the targeted number of participants now enrolled in the trial, Cassiopea is on track to deliver data late next year, a timeline that would position it to file for approval by mid-2018. Valeant ($VRX) has first refusal on the drug if Cosmo wants to make a deal.

The success, or otherwise, of that program will go a long way to dictating how well Cassiopea fares as an independent company in the near to midterm. Cosmo spun off its dermatology assets to form Cassiopea last year, going on to raise CHF 175.6 million ($178 million) in an IPO. The IPO broadened Cassiopea’s shareholder base but still left Cosmo holding approximately half of the company.

- view the presentation (PDF)
- read the report (PDF)

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Cosmo moves to spin out clinical-phase dermatology assets in Swiss IPO