US FDA orders Scynexis not to start new trials of injectable antifungal

Scynexis HQ in New Jersey (source Scynexis website)

The US FDA has told Scynexis not to start trials of an injectable formulation of its candidate antifungal Scy-078 after several volunteers developed blood clots during a Phase I study.

New Jersey, US-based Scynexis announced the hold in a US Securities and Exchange (SEC) filing. The firm explaining that it followed a review of three mild-to-moderate thrombotic events in volunteers receiving the IV formulation of SCY-078.

Scynexis said: “The potential contribution of the IV formulation of SCY-078 to these events cannot be ruled out even though rates of thrombotic events due to intravenous catheters reported in the literature are comparable to those observed in the Phase 1 study.”

The firm confirmed it will not start any new trials “until the FDA completes a review of all available pre-clinical and clinical data of the IV formulation of SCY-078.”

Scynexis said it would meet with the US Food and Drug Administration (FDA) to discuss the review in the second quarter of 2017.

Ongoing trials of the oral formulation of the drug will continue according to Scynexis, which added that “future clinical development using the oral formulation of SCY-078 are unaffected by this regulatory action.”

Background

Scy-078 is a glucan synthase inhibitor being developed to treat systemic fungal diseases. It is a semi-synthetic derivative of enfumafungin.

The candidate was developed in collaboration with US drug manufacturer Merck, known as MSD outside the United States and Canada, under an agreement signed in 2002.

However, Merck handed rights to the drug – which is also known as MK-3118 - to Scynexis in 2013 following a portfolio review.

Merck - which is entitled to royalties if the drug is appreoved - also provided Scynexis with all the pre-clinical data and IND information it had amassed.

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