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SCYNEXIS to Present Preclinical Data on Second Generation Fungerp SCY-247 at the 11th Advances Against Aspergillosis and Mucormycosis Conference, January 25 – 27, in Milan, Italy

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SCYNEXIS, a biotechnology company (NASDAQ: SCYX), announced preclinical efficacy data on its second generation fungerp candidate SCY-247 for the treatment of mucormycosis at the 11th Advances Against Aspergillosis and Mucormycosis Conference. The study showed SCY-247's in vivo efficacy equivalent to currently used antifungals in treating a Mucorales pulmonary infection in immunosuppressed mice. The combination of SCY-247 with liposomal amphotericin B resulted in a significant survival improvement when compared to monotherapy. The study was funded by the National Institutes of Health (NIH) utilizing the National Institute of Allergy and Infectious Diseases suite of preclinical services for in vivo testing.
Positive
  • SCY-247 demonstrated in vivo efficacy equivalent to currently used antifungals in treating a Mucorales pulmonary infection in immunosuppressed mice.
  • The combination of SCY-247 with liposomal amphotericin B resulted in a significant survival improvement when compared to monotherapy.
  • The study was funded by the National Institutes of Health (NIH) utilizing the National Institute of Allergy and Infectious Diseases suite of preclinical services for in vivo testing.
Negative
  • None.

Insights

The presentation of SCY-247's preclinical efficacy data by SCYNEXIS is a pivotal moment in the field of infectious disease treatment. The data suggests that SCY-247 could be a potent player in the antifungal market, particularly for treating mucormycosis, a rare but deadly infection. Given that current treatment options are limited, the development of a new drug like SCY-247 could significantly disrupt the market.

From a biotechnological standpoint, the combination therapy's enhanced survival rate is noteworthy. This suggests a potential for SCY-247 to be used in conjunction with existing treatments, possibly leading to a new standard of care. Investors should closely monitor the progress of SCY-247 into clinical trials as it could have a substantial impact on SCYNEXIS's valuation and market share in the antifungal space.

The funding by the National Institutes of Health underscores the importance of SCY-247's development and the need for advanced treatments for drug-resistant infections. The NIH's involvement often indicates a high level of scientific interest and a recognition of the unmet medical need in this area. For stakeholders, this backing provides a layer of validation for the research and potential future financial support.

Furthermore, the preclinical results indicating efficacy equivalent to existing antifungals could suggest a favorable risk-benefit profile for SCY-247, which is critical in the progression of new drugs through the regulatory pathway. The medical research community and potential future patients could benefit from this innovation, especially considering the high mortality rates associated with mucormycosis.

The antifungal market is currently witnessing a demand for innovative treatments due to the rise of drug-resistant strains. SCY-247's promising preclinical data places SCYNEXIS in a strategic position within this niche market. The mention of a clinical study beginning by year-end provides a timeline for investors and analysts to track the drug's progress and potential commercialization.

Considering the severity of mucormycosis and its classification as an orphan disease, SCY-247 could benefit from various incentives such as market exclusivity, tax credits and expedited review processes. If the drug successfully transitions from preclinical to clinical stages, it could lead to significant financial implications for SCYNEXIS, including partnerships, increased funding opportunities and ultimately revenue generation upon market entry.

JERSEY CITY, N.J., Jan. 05, 2024 (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 preclinical efficacy data on its second generation fungerp candidate SCY-247 for the treatment of mucormycosis at the 11th Advances Against Aspergillosis and Mucormycosis (AAAM) Conference in Milan, Italy from January 25 – 27, 2024.

Poster Presentation:
   
Title: SCY-247, a novel second-generation IV/oral triterpenoid antifungal, is efficacious in the neutropenic mouse model of pulmonary mucormycosis
   
Presenting author: Dr. Ashraf Ibrahim, PhD, FAAM, FECCM (Professor of Medicine, Division of Infectious Disease, David Geffen School of Medicine UCLA)

In this preclinical study, SCY-247 demonstrated in vivo efficacy equivalent to currently used antifungals in treating a Mucorales pulmonary infection in immunosuppressed mice. Notably, the combination of SCY-247 with liposomal amphotericin B resulted in a significant survival improvement when compared to monotherapy.

“The results from this preclinical study are very encouraging and illustrate the significant potential for this novel fungerp candidate SCY-247,” said David Angulo, M.D., President and Chief Executive Officer of SCYNEXIS. “Groundbreaking treatment options are urgently needed to address the significant limitations in effective therapies for devastating and very often lethal fungal diseases such as mucormycosis. We continue to expeditiously progress the development of this promising antifungal with plans to begin a clinical study by year end.”

For more information, see the AAAM website here.

The study was funded by the National Institutes of Health (NIH) under NIH Task order A65 75N93022F00001 utilizing the National Institute of Allergy and Infectious Diseases (NIAID) suite of preclinical services for in vivo testing.

About SCY-247

SCY-247 is a second generation antifungal compound, from a novel class of structurally-distinct glucan synthase inhibitors, triterpenoids (fungerps), under development as therapeutic options for systemic fungal diseases. The triterpenoid class of antifungals represents the first new class of antifungal compounds since 2001. These agents combine the well-established activity of glucan synthase inhibitors with the potential flexibility of having oral and intravenous (IV) formulations. SCY-247 is in pre-IND development stage and has demonstrated broad-spectrum antifungal activity, in vitro and in vivo. SCYNEXIS anticipates that the U.S. Food and Drug Administration (FDA) may grant SCY-247 Qualified Infectious Disease Product (QIDP) and Fast Track designations for the IV and oral formulations of SCY-247.

About SCYNEXIS

SCYNEXIS, Inc. (NASDAQ: SCYX) is a biotechnology company pioneering innovative medicines to help millions of patients worldwide overcome and prevent difficult-to-treat infections that are becoming increasingly drug-resistant. SCYNEXIS is developing the company’s proprietary antifungal platform “fungerps.” Ibrexafungerp, the first representative of this novel class, has been licensed to GSK. The FDA approved BREXAFEMME® (ibrexafungerp tablets) in June 2021 for its first indication in vulvovaginal candidiasis (VVC), followed by a second indication in November 2022 for reduction in the incidence of recurrent VVC. Late-stage clinical investigation of ibrexafungerp for the treatment of life-threatening invasive fungal infections in hospitalized patients is ongoing. Additional antifungal assets from this novel class are currently in pre-clinical and discovery phase, including the compound SCY-247. For more information, visit www.scynexis.com.

Forward-Looking Statements

Statements contained in this press release regarding expected future events or results are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to statements regarding: SCYNEXIS’s plans to begin a clinical study in SCY-247 by year end. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, risks inherent in regulatory and other costs in developing products. These and other risks are described more fully in SCYNEXIS' filings with the Securities and Exchange Commission, including without limitation, its most recent Annual Report on Form 10-K filed on March 31, 2023, including under the caption "Risk Factors." All forward-looking statements contained in this press release speak only as of the date on which they were made. SCYNEXIS undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

CONTACT
Investor Relations
Irina Koffler
LifeSci Advisors
Tel: (646) 970-4681
ikoffler@lifesciadvisors.com


FAQ

What did SCYNEXIS announce at the 11th Advances Against Aspergillosis and Mucormycosis Conference?

SCYNEXIS announced preclinical efficacy data on its second generation fungerp candidate SCY-247 for the treatment of mucormycosis.

What were the key findings of the preclinical study on SCY-247?

The study showed SCY-247's in vivo efficacy equivalent to currently used antifungals in treating a Mucorales pulmonary infection in immunosuppressed mice. The combination of SCY-247 with liposomal amphotericin B resulted in a significant survival improvement when compared to monotherapy.

Who funded the study on SCY-247?

The study was funded by the National Institutes of Health (NIH) utilizing the National Institute of Allergy and Infectious Diseases suite of preclinical services for in vivo testing.

SCYNEXIS, Inc.

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