|Treat and prevent invasive fungal infections; Treat and prevent systemic Candida infections; Treat candidemia|
- Originator Seachaid Pharmaceuticals
- Developer Cidara Therapeutics
- Class Antifungals; Echinocandins; Small molecules
- Mechanism of Action Glucan synthase inhibitors
- Orphan Drug Status Yes - Candidiasis
- On Fast track Candidiasis; Vulvovaginal candidiasis
- Phase II Candidiasis; Vulvovaginal candidiasis
Most Recent Events
- 01 Jun 2016 Phase-II clinical trials in Vulvovaginal candidiasis in USA (Topical) (9197627; NCT02733432)
- 31 May 2016 CD 101 receives Qualified Infectious Disease Product status for Vulvovaginal candidiasis in USA
- 31 May 2016 CD 101 receives Fast Track designation for Vulvovaginal candidiasis [Topical] in USA
BIAFUNGIN, CD 101
Watch this space as I add more info................
U.S. - Fast Track (Treat and prevent invasive fungal infections);
U.S. - Orphan Drug (Treat and prevent invasive fungal infections);
U.S. - Orphan Drug (Treat candidemia);
U.S. - Qualified Infectious Disease Program (Treat candidemia);
U.S. - Qualified Infectious Disease Program (Treat and prevent invasive fungal infections)
- Pneumocandins (cyclic hexapeptides linked to a long-chain fatty acid)
- Echinocandin B not clinically used, risk of hemolysis
- Cilofungin withdrawn from trials due to solvent toxicity
- Caspofungin (trade name Cancidas, by Merck)
- Micafungin (FK463) (trade name Mycamine, by Astellas Pharma.)
- Anidulafungin (VER-002, V-echinocandin, LY303366) (trade name Eraxis, by Pfizer)
Cidara has an impressive executive team. The company was co-founded by Kevin Forrest, former CEO of Achaogen (NASDAQ: AKAO), and Shaw Warren. Jeffrey Stein, former CEO of Trius Therapeutics (NASDAQ: TSRX) and Dirk Thye, former president of Cerexa, have joined Cidara as CEO and CMO, respectively. Trius successfully developed antibiotic tedizolid and was acquired in 2013 by Cubist Pharmaceuticals (NASDAQ: CBST) for $818 million.
Cidara’s lead candidate, biafungin (SP3025), was acquired from Seachaid Pharmaceuticals for $6 million. Biafungin’s half-life is much longer than that of similar drugs known as echinocandins (e.g., caspofungin, micafungin, anidulafungin), which may allow it to be developed as a once-weekly therapy, instead of once daily. The company is also developing a topical formulation of biafungin, namely topifungin. Cidara intends to file an IND and initiate a Phase I clinical trial in the second half of 2015.
Merck’s Cancidas (caspofungin), launched in 2001, was the first of approved enchinocandins. The drug generated annual sales of $596 million in 2008. The approved echinocandins must be administered daily by intravenous infusion. Biafungin with improved pharmacokinetic characteristics has the potential to bring in hundreds of millions of dollars per year.
 Nat Biotechnol. 2015, 33(1), 18.
- Denning, DW (June 2002). "Echinocandins: a new class of antifungal.". The Journal of antimicrobial chemotherapy 49 (6): 889–91. doi:10.1093/jac/dkf045. PMID 12039879.
- Morris MI, Villmann M (September 2006). "Echinocandins in the management of invasive fungal infections, part 1". Am J Health Syst Pharm 63 (18): 1693–703.doi:10.2146/ajhp050464.p1. PMID 16960253.
- Morris MI, Villmann M (October 2006). "Echinocandins in the management of invasive fungal infections, Part 2". Am J Health Syst Pharm 63 (19): 1813–20.doi:10.2146/ajhp050464.p2. PMID 16990627.
- "Pharmacotherapy Update - New Antifungal Agents: Additions to the Existing Armamentarium (Part 1)".
- Debono, M; Gordee, RS (1994). "Antibiotics that inhibit fungal cell wall development".Annu Rev Microbiol 48: 471–497. doi:10.1146/annurev.mi.48.100194.002351.
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