Destiny has announced the top-line results of its Phase 2b clinical study of XF-73 in the prevention of staphylococcal post-surgical infection. As an active antimicrobial agent, we had expected XF-73 to have efficacy in this indication, but the strength of the data was an outstanding result.
Specifically, there was a greater than 99% reduction in nasal carriage achieved in just 24 hours, the primary endpoint of the study, compared to placebo. Destiny is now in the attractive but unusual situation (amongst UK biotech companies) of having two Phase 3-ready assets: XF-73 and also NTCD-M3 targeting prevention of C.difficile infection recurrence.
In Destiny’s Phase 2b study of the XF-73 nasal formulation, the primary endpoint of microbiological eradication of Staphylococcus aureus (S.aureus), including MRSA, nasal carriage just before surgery, compared to placebo, was met with high statistical significance (p<0.0001). As expected, the XF-73 nasal formulation was safe, with no treatment-related adverse events.
Work on the design of a Phase 3 program following the success of the Phase 2b study is now underway and will be important for partnering discussions. On partnering, our model assumes a single global licensing transaction for the XF-73 nasal product later this year. Those assumptions remain unchanged, although we now recognise that the success of the Phase 2b study may encourage Destiny to sign regional licensing transactions that fund the Phase 3 program, while retaining rights in other markets until a later stage, in order to generate higher shareholder value.
Our fair value of Destiny Pharma has increased to £213.6m (357p per share) from £156.9m (262p per share) as a result of Destiny becoming a company with two Phase 3-ready programs.