Basilea - Fosmanogepix Phase 3 begins

As expected, Basilea announced this morning that the first of two Phase 3 studies involving its novel antifungal fosmanogepix has been initiated. The candidaemia/invasive candidiasis study is a randomised, double-blind trial intended to show non-inferiority to standard of care. The Fosmanogepix Against Standard-of-care Treatment in Invasive Candidiasis (FAST-IC) trial aims to enrol 450 patients and will compare fosmanogepix to caspofungin. The primary endpoint agreed with FDA is 30-day survival, while for EMA approval, the primary endpoint is overall response at the end of treatment.  

The second Phase 3 study, due to begin around year-end, targets invasive mould, is open-label, and is expected to enrol about 200 patients. The study aims to compare fosmanogepix versus the best available therapy against a broad range of clinically and commercially relevant invasive fungal infections, including Invasive Aspergillus, Fusarium spp, Scedosporium spp, Mucorales, Lomentospora prolificans, as well as other multi-drug resistant moulds. Given that fosmanogepix has obtained Fast Track status from FDA for seven different fungal infections, we believe that fosmanogepix will be relevant to a broad range of critical fungal pathogens. Furthermore, a comprehensive Phase 2 programme has largely de-risked the Phase 3 clinical evaluation of fosmanogepix. 

Basilea acquired fosmanogepix in November 2023 from Amplyx Pharmaceuticals, an affiliate of Pfizer. Under the terms of a previous agreement, Basilea will make a $6 million milestone payment upon the enrolment of the first patient, which is included in Basilea’s financial guidance for 2024. This project has been partially funded with awards from BARDA and others, reflecting its importance.

As previously highlighted, we believe that fosmanogepix promises not only to add longevity to the antifungal franchise which is currently dominated by targeting invasive fungal infections (particularly invasive aspergillosis) but should also extend the franchise into the treatment of candidiasis – a rapidly growing fungal threat. Importantly, fosmanogepix addresses almost all of the fungal infections highlighted by the WHO in its list of critical fungal infections. All of the above underpins our $1.2bn peak sales estimate for fosmanogepix.

We have a discounted cash flow fair value of CHF 110 per share for Basilea.

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