SCYNEXIS Inc (NASDAQ:SCYX) said that a Phase 3 program is underway to evaluate an oral formulation for the treatment of an acute type of vaginal yeast infection.
The biotech company said in a statement accompanying its annual earnings report Thursday that it expects top-line data in the first half of 2020 on the use of oral ibrexafungerp for the treatment of acute vulvovaginal candidiasis (VVC). It expects a new drug application submission with the Food and Drug Administration in the second half of 2020.
"We fully intend to carry the momentum of 2018 throughout this year,” Dr Marco Taglietti, president and CEO of the Jersey City, New Jersey, company, said in a statement.
Ibrexafungerp, formerly SCY-078, is being developed for oral and intravenous administration and is in clinical development for the treatment of several serious fungal infections, including VVC, invasive candidiasis, invasive aspergillosis and refractory invasive fungal infections.
If approved, ibrexafungerp would be the only oral alternative to azoles for the treatment of VVC and the prevention of recurrent VVC, according to SCYNEXIS.
The company ended 2018 with positive results from its Phase 2b study evaluating ibrexafungerp with VVC, according to Taglietti.
SCYNEXIS’s VANISH program is made up of two Phase 3 clinical trials with about 350 patients each to evaluate the effectiveness of a one-day 600 mg oral dose of ibrexafungerp compared with a placebo for the treatment of VVC.
Company's cash position
The company added that it raised $16 million in March through the sale of convertible debt to retire a maturing term loan.
SCYNEXIS said the move enhances an already strong cash balance and extends its cash runway past the expected new drug application submission in the second half of 2020. Cash, cash equivalents and short-term investments totaled $44.2 million as of December 31.
Shares of the SCYNEXIS slipped US$0.04 to $1.54 in Friday’s premarket trading.
The company posted a 2018 net loss of $12.5 million, or $0.28 per share, compared with a net loss for 2017 of $25.1 million, or $0.94 per share.
Contact Dennis Fitzgerald at [email protected]