Company: SCYX
Filing Date: 2025-03-12
Form Type: 10-K
Source: 0000950170-25-038044
Chunk: 25

Company: SCYNEXIS INC
Filing Date: 2025-03-12
Form: 10-K
Item: Item 1
Chunk 25
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ifungal therapeutics.  They are being developed as oral and IV formulations and have demonstrated potent activity against a large collection of medically relevant strains of Candida and Aspergillus genera, including multidrug-resistant strains, as well as Pneumocystis, Coccidioides, Histoplasma, and Blastomyces genera. Additionally they have shown in vivo activity in multiple preclinical models of invasive fungal infections including IC, IA and mucormycosis. 

Unique attributes of this novel class of antifungals that define its potential to address significant unmet medical needs and provide considerable commercial opportunities include:

•oral bioavailability, unlike other glucan synthase inhibitors, allowing for convenient long-term outpatient use;

•distinct chemical structure from other glucan synthase inhibitors, providing a unique spectrum of activity and pharmacokinetic profile;

•activity against azole-resistant and most echinocandin-resistant Candida strains, including Candida auris and multidrug-resistant strains;

•activity against azole-resistant Aspergillus strains;

•fungicidal (i.e., killing the fungi) capabilities against the Candida genus compared to azoles, which are fungistatic (i.e., only inhibiting the growth of fungi); 

•high tissue penetration, allowing high concentrations in the organs commonly affected by fungal infections;

•half life adequate for once a day administration; and

•low risk of drug-drug interactions.

Two antifungals of this novel class have progressed to clinical development: ibrexafungerp, the first representative of this novel class to a obtain a regulatory approval, and SCY-247, our second generation fungerp.

Ibrexafungerp Product Profile

Ibrexafungerp was developed as an oral formulation for the treatment of VVC and the reduction of the incidence of RVVC.  The FDA has approved ibrexafungerp (commercial name, BREXAFEMME) for these two indications.  Additionally, oral ibrexafungerp has been studied for the treatment of refractory fungal infections and is under investigation as an oral step-down option for the treatment of IC.  GSK has licensed global rights for ibrexafungerp and any NDA submissions for new indications would be made by GSK and any resulting approval(s) would be held by GSK. 

SCY-247 Product Profile

SCY-247, our second generation fungerp, entered into Phase 1 of the clinical development in the fourth quarter of 2024