Basilea Pharmaceutica (SWX:BSLN) has come out of talks with the FDA with a clearer idea of how it will design Phase III trials of its broad-spectrum antibiotic. But with its ambition to list on Nasdaq consigned to the scrapheap, Basilea is now steadfast in its desire to find a partner before kicking off the trials.
When Basilea filed for a $190 million (€175 million) Nasdaq IPO back in October, the company said the start of the Phase III trial was dependent on either snagging a partner or securing funding for the study. Basel, Switzerland-based Basilea has since dropped its plan to list on Nasdaq in the face of a frosty reception from Wall Street. And, while the Roche ($RHHBY) spinout has moved to top up its bank balance with a CHF 175 million bond sale, the setback has solidified its desire to find a partner before advancing into Phase III.
"Basilea currently expects that it would not initiate Phase III studies until such time as it has entered into a collaboration agreement with a third party," the company wrote in a statement to outline its plans. The commitment to finding a partner before kicking off the studies means Basilea is advancing its business development activities in parallel to preparations for the Phase III trials. While details of the status of the partnership talks are scarce, Basilea has been more forthcoming about the progress of the other tasks that stand between it and the start of the late-phase program.
The next step is to prepare the study protocols Basilea hopes will result in a written agreement with the FDA about the design of the program. Basilea is aiming to have the protocols in front of the regulator in the first quarter of the year. The details of exactly what Basilea is hoping to achieve in the trials has shifted slightly following recent talks with the FDA. Notably, Staphylococcus aureus bloodstream infections, such as the heart condition known as endocarditis, are now on the list of indications for the study, having previously been considered a "maybe" by the company.
Other aspects of the late-phase program are unchanged. As Basilea said when filing to list in the U.S., the program will feature cross-supportive studies in community-acquired bacterial pneumonia and a pair of skin infections. Bloodstream infections will now join these two indications in the program.
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