Scynexis

Pharmaceutical SME
Stock Exchange: NASDAQ Ticker: SCYX HQ: New Jersey, USA Employees: 24
Performance in the Benchmark
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Overall score
45%
9/20
Performance by Research Area
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R&D
45%
Points 9/20
0% 50% 100%

Benchmark Performance

Scynexis performs on average in Research & Development when compared to other small and medium-sized enterprises in scope.

R&D

Scynexis has five antifungal projects in its pipeline, including one clinical-stage antifungal medicine project that is considered novel: ibrexafungerp, for the treatment of various fungal infections, including acute vulvovaginal candidiasis. Reports commitment to increase access to its products through expanded access programmes.


Sales & Operations

Therapeutic areas: Multiple serious fungal infections
Products on the market: None
R&D grants received since 2016: None
Financing and investment structure: Scynexis is a publicly listed company. It completed its IPO in May 2014 raising USD 62 million, following one venture round raising USD 11.4 million.
M&A since 2018: None in the antibacterial and/or antifungal sectors

Revenues (2018)

Pipeline

for diseases in scope

Pipeline size: 5 projects for priority pathogens* (1 antifungal medicine for 5 indications)
Development stages: 5 clinical projects, 4 of which are Phase III clinical trials (including 2 open label studies) and an additional study in Phase II for invasive candidiasis
Novelty: 1 novel project, ibrexafungerp, a Phase III clinical candidate for the treatment of various fungal infections, including acute vulvovaginal candidiasis, that belongs to a new chemical class of antifungals.
Regulatory approvals: 0 approvals for priority pathogens
Access plans: No project-specific access plans are in place for its 5 late-stage R&D projects, but the company has a general approach to increasing access through expanded access programmes.
Stewardship plans: None of its 5 late-stage R&D medicine projects have project-specific stewardship plans.

Opportunities for Scynexis

Expand access plans and develop stewardship plans for ibrexafungerp. Scynexis has developed expanded access plans for ibrexafungerp that will enable seriously ill patients not enrolled in its clinical studies to have access to the investigational product. Scynexis can expand its access plans by committing to an equitable pricing strategy and/or looking for multiple licensees in low- and middle-income countries. Scynexis has not developed stewardship plans for ibrexafungerp yet. As examples of stewardship plans, the company can commit to decouple sales incentives from sales volumes and/or become involved in antifungal surveillance activities.

Changes since 2018

This section lists notable changes in companies’ activities since the 2018 Benchmark. Since Scynexis was not in scope for evaluation in 2018, no changes are reported.  


Performance by research area

A. Research & Development

Indicators scored on
  • total
  • max
  • percentage

Evaluated: medicine & vaccine pipelines for priority* bacteria & fungi

A.1 R&D investments
Scynexis invested USD 39.9 million in the development of antifungal medicines in 2017 and 2018. As with all other SMEs evaluated, Scynexis was not scored in this indicator.

A.2.1 Pipeline size of five projects
Scynexis reports five projects targeting Candida spp. in its pipeline for different indications for its candidate ibrexafungerp. The company is focused entirely on antifungal medicine development. Four projects are in Phase III of clinical development and one is in Phase II.

A.2.2 One clinical-stage novel project
Scynexis’ clinical-stage medicine pipeline for priority pathogens consists of both new and adapted R&D projects. Scynexis has one clinical-stage antifungal medicine project that is considered novel: ibrexafungerp, for the treatment of various fungal infections, including acute vulvovaginal candidiasis, that belongs to a new chemical class.

A.2.3 Vaccines in the pipeline
Scynexis is not eligible for this indicator as it is not active in vaccine development.

A.2.4 One candidate targeting critical and/or urgent priorities
Scynexis’ clinical pipeline includes one new, novel candidate (ibrexafungerp/SCY-078) in Phase III that targets multi-drug resistant C. auris, which is listed since November 2019 as an urgent pathogen by the US Centers for Disease Control and Prevention (CDC). 

A.3 Intellectual capital sharing
As an SME, Scynexis was not scored for this indicator, in line with the external stakeholder consensus defined by the Foundation.

A.4 General access commitments for 5 of 5 projects; no stewardship plans
Scynexis has five late-stage R&D projects targeting priority pathogens, all for different indications for ibrexafungerp. Scynexis has developed expanded access plans for ibrexafungerp that will enable seriously ill patients not enrolled in its clinical studies to have access to the investigational product. It does not report on any stewardship plans.

Pipeline targeting priority pathogens: 5

B. Responsible Manufacturing

As a small- to medium-sized enterprise (SME), Scynexis is not evaluated in this Research Area. It has no antibacterial products on the market.

C. Appropriate Access & Stewardship

As a small- to medium-sized enterprise (SME), Scynexis is not evaluated in this Research Area. It has no antibacterial and/or antifungal products on the market.


* Bacteria and fungi that have been identified as priority R&D targets for limiting AMR, by either the WHO and/or the Centers for Disease Control and Prevention (CDC). 


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