SCYNEXIS & GSK Announce Exclusive Agreement to Commercialize & Further Develop Novel, First-in-Class Medicine to Treat Fungal Infection

SCYNEXIS, Inc. GSK plc recently announced they have entered into an exclusive license agreement for Brexafemme (ibrexafungerp tablets), a US FDA-approved, first-in-class antifungal for the treatment of vulvovaginal candidiasis (VVC) and for reduction in the incidence of recurrent VVC (RVVC). This exclusive licence agreement gives GSK rights to commercialise Brexafemme for VVC and RVVC while continuing to develop ibrexafungerp, which is in phase III clinical trials for the potential treatment of invasive candidiasis (IC), a life-threatening fungal infection.

Infectious diseases and HIV represent around two-thirds of GSK’s pipeline. Brexafemme complements GSK’s first or best-in-class portfolio alongside late-stage antibiotics gepotidacin, potentially the first novel antibiotic for uncomplicated urinary tract infections (uUTI) in over 20 years, and tebipenem, a potential new treatment of complicated urinary tract infections (cUTI).

Luke Miels, Chief Commercial Officer GSK, said “The challenge of antimicrobial resistance includes increasing rates of multi-drug resistant fungal infections. Brexafemme is a novel, approved antifungal medicine with a broad spectrum of activity against existing and emerging resistant strains of fungi. In addition, the transaction consolidates GSK’s synergistic portfolio of innovative late-stage antibiotics.”

VVC affects up to 75% of women at least once, with 40%-45% having two or more episodes. Brexafemme has a distinct mechanism of action whereby it kills the fungus, as opposed to some antifungals which inhibit fungal growth. It is the only oral antifungal US FDA-approved treatment for VVC and reduction of RVVC. With rates of resistance to other antifungal treatments rising, Brexafemme addresses a clear unmet need for new oral treatments.

David Angulo, MD, President and Chief Executive Officer of SCYNEXIS, added “This agreement represents a major milestone for SCYNEXIS, maximising Brexafemme’s commercial potential in VVC and further validating our vision of the critical role for this first-in-class antifungal in invasive infections. We are thrilled to partner with GSK on this high-potential asset and will continue progressing ibrexafungerp’s Phase 3 program in invasive candidiasis (IC).”

IC is a life-threatening infection that affects the blood or internal organs. There are around 750,000 cases of IC every year worldwide. In the US, it is one of the most common causes of bloodstream infections in hospitalised patients and can lead to more extended hospital stays and higher associated costs.

Under the terms of the agreement, GSK will make an upfront payment to SCYNEXIS of $90 million, plus additional potential milestone-based payments totalling $503 million. GSK will pay up to $245.5 million if specific development, regulatory, and commercial milestones associated with the IC indication are successfully completed. A further $15 million milestone will be paid upon successful US FDA approval of an additional indication.

GSK will pay sales-related milestone payments based on achieving a certain commercial performance of up to $242.5 million, and mid-single digit to mid-teen digit tiered royalties on the totality of sales across all indications (in both cases with the top tier based on achieving net sales greater than $1 billion).

GSK will also receive an exclusive license to develop ibrexafungerp and commercialize Brexafemme in all countries except the greater China region and certain other countries already out-licensed by SCYNEXIS to third parties. Under the license agreement, SCYNEXIS will continue executing the Phase 3 program for IC and other ongoing trials.

SCYNEXIS retains rights to all other assets derived from enfumafungin. As part of this exclusive license agreement, GSK has been granted a right of first negotiation to these compounds. This agreement is conditional upon customary conditions including review by the appropriate regulatory agencies under the Hart-Scott-Rodino Act.

Aquilo Partners, L.P. is acting as financial advisor and Cooley LLP as legal advisor to SCYNEXIS on this transaction.

Brexafemme (ibrexafungerp tablets) is a novel oral glucan synthase inhibitor with a broad spectrum of activity including against emerging resistant threats. Its mechanism of action is similar to echinocandins, with fungicidal action against yeast (meaning it kills the fungus), versus fluconazole which is fungistatic (meaning it inhibits fungal growth). It was first approved in the US in 2021 for the treatment of VVC and is the first and only oral antifungal approved for both the treatment of VVC and the reduction of the incidence of RVVC. Brexafemme has proven activity against WHO-designated priority fungal pathogens such as Candida albicans. In addition, ibrexafungerp has shown activity against Candida auris, another WHO-designated priority fungal pathogen.

VVC is a widespread vaginal infection primarily caused by a fungus called Candida albicans. Surveys suggest that VVC affects up to 75% of women once in their life, and 40%–45% have two or more episodesⁱ. RVVC is a debilitating, long-term condition that can severely affect the quality of life of affected women.

Although not life-threatening, VVC does cause severe itching, soreness, and vaginal irritation, interfering with normal sexual relations. These symptoms and manifestations are considerably magnified when attacks are frequent and recurrent and when the disease is refractory to conventional therapy.

For the 30% of patients with complicated VVC, which includes recurrent, azole-resistant or refractory VVC, there are limited treatment options, with current guidelines limited to using the same treatment for a longer duration.

IC is a life-threatening fungal infection caused by Candida that affects the blood or internal organs. In the US, it is one of the most common causes of bloodstream infections in hospitalised patients, leading to longer hospital stays, higher associated costs, and death. People at risk include patients with a prolonged stay in an Intensive Care Unit and those with a weakened immune system, eg, chemotherapy or organ transplant.

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 scientists are developing the company’s lead asset, ibrexafungerp (formerly known as SCY-078), as a broad-spectrum, systemic antifungal for multiple fungal indications in both the community and hospital settings. The US FDA-approved BREXAFEMME (ibrexafungerp tablets) on June 1, 2021, for its first indication in vulvovaginal candidiasis (VVC), followed by a second indication on November 30, 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 assets derived from enfumafungin are currently in pre-clinical and discovery phase. For more information, visit www.scynexis.com.

Infectious diseases and HIV represent around two-thirds of GSK’s pipeline and its primary focus for R&D. In antibiotics, gepotidacin is a late-stage potential treatment for uncomplicated urinary tract infections (uUTI) and could be the first novel oral antibiotic for uUTI in more than 20 years. In addition, in September 2022, GSK entered into an exclusive licence agreement with Spero Therapeutics, Inc. to add tebipenem HBr, another late-stage antibiotic and potential treatment for complicated urinary tract infections (cUTI), to its pipeline.