SCYNEXIS, Inc. (0L49.L)

SCYNEXIS Presents Positive Interim Data of Ibrexafungerp for Refractory Candida Infections from Ongoing Phase 3 FURI Study During the Mycoses Study Group Education and Research Consortium (MSGERC) Biennial Meeting
Download as PDF September 08, 2022
Approximately 83% of FURI patients with refractory Candida infections had positive clinical outcomes, defined as complete/partial response (56%) or no disease progression (27%).
Data from the ongoing Phase 3 CARES study will also be presented demonstrating positive outcomes of ibrexafungerp in 89% of patients with Candida auris, complete/partial response (78%) and no disease progression (11%).
JERSEY CITY, N.J., Sept. 08, 2022 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced the presentation of positive interim data in patients with refractory candidiasis treated with oral ibrexafungerp from the ongoing Phase 3 FURI study, as well as data from the ongoing CARES study of patients with Candida auris (C. auris) infections. The new interim analyses are being presented during the Mycoses Study Group Education and Research Consortium (MSGERC) Biennial Meeting being held in Albuquerque, N.M., September 7-9, 2022.

“We are pleased to present to the scientific community these interim results from our ongoing FURI and CARES studies showing clinical benefits in patients with serious Candida fungal infections,” said Nkechi Azie, M.D., Vice President, Clinical Development and Medical Affairs at SCYNEXIS. “These encouraging results highlight the potential role of ibrexafungerp in treating a broad spectrum of challenging fungal diseases.”

The interim analysis included 64 patients from the FURI study with refractory Candida infections, including failure of or resistance to previous standard-of-care antifungal therapy. In the study, 56% of patients had a complete or partial response, 27% had stable response, 9% showed disease progression, and 8% were indeterminate (including one death due to underlying disease). Among these patients, 71% of refractory vulvovaginal candidiasis (VVC) cases (10/14) treated with an investigational dose regimen of ibrexafungerp showed clinical improvement as determined by vulvovaginal signs and symptoms score ≤1 at test of cure, 7% had stable response, 14% showed disease progression, and 7% were indeterminate.

Outcomes for the ongoing Phase 3 CARES study of ibrexafungerp in the treatment of patients with C. auris infections also are being presented at MSGERC. Of the 18 patients with invasive candidiasis/candidemia due to C. auris, 78% had a complete or partial response, 11% had stable response, one patient died of other causes, and one outcome was indeterminate.

The ongoing Phase 3 open-label, single-arm FURI study (NCT03059992) is evaluating oral ibrexafungerp for the treatment of patients with severe fungal infections who are either intolerant to standard antifungal therapy or experience refractory fungal infections despite treatment. The Phase 3 CARES study (NCT03363841) is evaluating oral ibrexafungerp in patients with systemic infections caused by C. auris, an organism that is often multi-drug resistant and associated with high mortality.

SCYNEXIS to Present Posters Highlighting Ibrexafungerp Data at Four Upcoming Scientific Meetings in September 2022
Download as PDF September 01, 2022
JERSEY CITY, N.J., Sept. 01, 2022 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced it will present posters at four upcoming U.S. and international medical conferences in September.

United States

Mycoses Study Group Education and Research Consortium (MSGERC) Biennial Meeting – September 7-9, 2022, Albuquerque, N.M.

Title: Outcomes of Oral Ibrexafungerp in Refractory Patients with Candida Infections from an Open-Label Study in Patients with Serious Fungal Infections (FURI)
Date: Friday, September 9
Time: 3:30 pm – 5:00 pm MDT
Presenter: Nkechi Azie, M.D.

Title: Outcomes of Oral Ibrexafungerp in the Treatment of 10 Patients with Candida auris Infections, from the CARES Study
Date: Friday, September 9
Time: 3:30 pm – 5:00 pm MDT
Presenter: Nkechi Azie, M.D.
World Anti-Microbial Resistance (AMR) Congress – September 7-9, 2022, National Harbor, Md.

Title: Ibrexafungerp, a Novel Triterpenoid Antifungal in Development for the Treatment of CDC Urgent Threat Pathogen, Candida auris
Date: Wednesday, September 7, and Thursday, September 8
Time: 10:20 am EDT both days
Presenter: Thomas King, MS, MPH
International

International Immunocompromised Host Society (ICHS) – September 8-11, 2022, Basel, Switzerland

Title: Oral Ibrexafungerp Outcomes in Patients with Chronic Mucocutaneous Candidiasis (CMC)
Date: Saturday, September 10
Time: 10:00 am -10:30 am CEST
Presenters: Riina Rautemma-Richardson and Chris Eades, Manchester University
21st Congress of the International Society for Human and Animal Mycology (ISHAM) –September 20-24, 2022, New Delhi, India

Title: All-Cause Mortality in Patients with Invasive Candidiasis or Candidemia from an Interim Analysis of a Phase 3 Open-label Study (FURI)
Date: Wednesday, September 21
Time: 12:30 pm - 1:30 pm IST
Presenter: Juergen Prattes, M.D., Medical University of Graz

Title: Oral Ibrexafungerp Outcomes by Fungal Disease in Patients from an Interim Analysis of a Phase 3 Open-label Study (FURI)
Date: Wednesday, September 21
Time: 12:30 pm - 1:30 pm IST
Presenter: Juergen Prattes, M.D., Medical University of Graz

SCYNEXIS Presents Positive Data from Its Pivotal Phase 3 CANDLE Study of Oral Ibrexafungerp for Prevention of Recurrent Vaginal Yeast Infections During the 2022 IDSOG Annual Meeting
Download as PDF August 04, 2022
The CANDLE study met its primary endpoint, with 65.4% of patients with recurrent vulvovaginal candidiasis (RVCC) who received monthly single-day ibrexafungerp treatment achieving clinical success with no recurrence at all, either culture-proven, presumed or suspected.

Ibrexafungerp achieved statistically significant superiority over placebo in both primary and key secondary endpoints, including no mycologically proven recurrence in 70.8% of patients.

In a nested sub-study of ibrexafungerp in RVVC patients who failed to respond to a three-day initial regimen of fluconazole, one-day treatment with ibrexafungerp achieved a substantial reduction or complete elimination of symptoms in 71% of patients.
SCYNEXIS has submitted a supplemental New Drug Application (sNDA) for a label expansion to include the prevention of RVCC and anticipates final review by the U.S. Food and Drug Administration with a regulatory decision target date of November 30, 2022.

Exactly what part of "NO" is the Board having a problem understanding?

Dear Stockholder:
We are holding a Special Meeting to bring the Charter Amendment Proposal (defined below) to another vote. Stockholders voting at our 2022 Annual Meeting of Stockholders overwhelmingly voted to approve the Charter Amendment Proposal, with support from approximately 80% of the shares voted in person or by proxy. Unfortunately, because only 57% of our outstanding shares were present and entitled to vote at the 2022 Annual Meeting of Stockholders, the Charter Amendment Proposal did not receive the requisite approval by a majority of our shares outstanding. We are now giving our stockholders another opportunity to approve the Charter Amendment Proposal and have engaged a proxy solicitor to help us obtain stronger stockholder turnout at the Special Meeting so that approval of the Charter Amendment Proposal will be achieved. We encourage all of our stockholders to vote in person or by proxy at the Special Meeting.
You are cordially invited to attend the 2022 Special Meeting of Stockholders of SCYNEXIS, Inc., a Delaware corporation. The meeting will be held on     , 2022, at 9:30 a.m., Eastern time. The special meeting will be a completely virtual meeting of stockholders. Instructions on how to participate in the special meeting and demonstrate proof of stock ownership are posted at www.virtualshareholdermeeting.com/SCYX2022SM. The special meeting will be held for the following purposes:
1.
To amend SCYNEXIS’s Amended and Restated Certificate of Incorporation, as amended, to increase the total number of authorized shares of common stock from 100,000,000 to 150,000,000 (the “Charter Amendment Proposal”); and
2.
To approve the adjournment of the special meeting to a later date or dates, if necessary, to permit further solicitation and vote of proxies in the event that there are insufficient votes for, or otherwise in connection with, the approval of the Charter Amendment Proposal (the “Adjournment Proposal”).

If the label is expanded, Brexafemme will be the only oral FIRST LINE treatment for rVVC. They could actually make a lot of money on this one. Apparently, over 500K women suffer from rVVC (in the US alone); the numbers in Asia are a lot higher. Rather than sound like a sophist, I'd like to post the supporting article but, alas, Yahoo is doing its thing. In any event, adopting those Rx's would materially increase revenues. Hmmm, perhaps November will tell the tale.

Cheers,

Z

JERSEY CITY, N.J., Aug. 01, 2022 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s submission of a supplemental New Drug Application (sNDA) to expand the label of BREXAFEMME® (ibrexafungerp tablets) to include the prevention of recurrent vulvovaginal candidiasis (RVVC). The FDA granted the submission Priority Review and assigned the Prescription Drug User Fee Act (PDUFA) target decision date as November 30, 2022.

If approved for this second indication, BREXAFEMME, an oral non-azole therapy, would be the first and only product approved in the U.S. for both the treatment of vulvovaginal candidiasis (VVC) and the prevention of RVVC, defined as three or more infections in a 12-month period.

“The FDA’s acceptance of this submission is excellent news for patients, and it brings us another step closer to our vision of addressing significant unmet needs in women’s health,” said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. “Our pivotal CANDLE study was the basis of the sNDA submission, and we look forward to presenting details of these data to the medical community.”

SCYNEXIS will present CANDLE study results this week at the Infectious Diseases Society for Obstetrics and Gynecology (IDSOG) Annual Meeting being held in Boston August 4-6, 2022.

Ibrexafungerp is designated by the FDA as a qualified infectious disease product (QIDP), allowing for a six-month priority review.