BUY (SCYX, $3.43)
SCY-078 Successfully Formulated As An IV – Long-Term Animal Safety Also Established: Reiterate BUY/$14 TP
December 13, 2016
Jonathan Aschoff, Ph.D.
- An intravenous (IV) formulation and dosing regimen has been identified for SCY-078 in a Phase 1 trial in healthy volunteers, and pending discussion with the FDA, will be tested in upcoming trials in fungal infection.
- The safety of oral SCY-078 has been demonstrated in longer-term rat and dog studies, thereby confirming the drug’s favorable safety profile shown in prior shorter duration safety studies.
- We view both developments as clearly positive, as they importantly support SCY-078’s versatile dosing (oral and IV) and long-term tolerability.
- Dosing flexibility is critical when starting a hospitalized patient on an IV antifungal and wanting to send them home with an oral version of a drug to which they are clearly responding.
- Long-term (90 day, in this case) safety is critical to establish given that patients with invasive Aspergillus or refractory fungal infections sometimes require up to 90 days of treatment.
- With the dosing flexibility and long-term safety established, SCYNEXIS can now progress with its pivotal trial in refractory invasive fungal infection and its Phase 2 trial in invasive candidiasis.
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