Ongoing and future clinical development using the oral formulation of SCY-078 are unaffected
JERSEY CITY, NJ, USA I March 02, 2017 I Drug development company SCYNEXIS, Inc. (Nasdaq:SCYX) today announced that the United States Food and Drug Administration (FDA) has informed the Company to hold the initiation of any new clinical studies with the intravenous (IV) formulation of SCY-078 until the FDA completes a review of all available pre-clinical and clinical data of the IV formulation of SCY-078. Ongoing and future trials using the oral formulation of SCY-078 are unaffected by this regulatory action. A meeting with the FDA to discuss these data and to agree on subsequent clinical studies with the IV formulation of SCY-078 is scheduled for the second quarter of 2017.
The clinical hold decision was issued by the FDA following a review of three mild-to-moderate thrombotic events in healthy volunteers receiving the IV formulation of SCY-078 at the highest doses and highest concentrations in a Phase 1 study. 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.
SCYNEXIS is working closely with the FDA to review the data supporting the use of the IV formulation and dose regimen of SCY-078 selected by the Company for its upcoming clinical trials.
About SCYNEXIS
SCYNEXIS is a drug development company committed to the development and commercialization of novel anti-infectives to address significant unmet therapeutic needs. We are developing our lead product candidate, SCY-078, as an oral and IV drug for the treatment of several fungal infections, including serious and life-threatening invasive fungal infections. For more information, visit www.scynexis.com.
SOURCE: Scynexis
Post Views: 43
Ongoing and future clinical development using the oral formulation of SCY-078 are unaffected
JERSEY CITY, NJ, USA I March 02, 2017 I Drug development company SCYNEXIS, Inc. (Nasdaq:SCYX) today announced that the United States Food and Drug Administration (FDA) has informed the Company to hold the initiation of any new clinical studies with the intravenous (IV) formulation of SCY-078 until the FDA completes a review of all available pre-clinical and clinical data of the IV formulation of SCY-078. Ongoing and future trials using the oral formulation of SCY-078 are unaffected by this regulatory action. A meeting with the FDA to discuss these data and to agree on subsequent clinical studies with the IV formulation of SCY-078 is scheduled for the second quarter of 2017.
The clinical hold decision was issued by the FDA following a review of three mild-to-moderate thrombotic events in healthy volunteers receiving the IV formulation of SCY-078 at the highest doses and highest concentrations in a Phase 1 study. 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.
SCYNEXIS is working closely with the FDA to review the data supporting the use of the IV formulation and dose regimen of SCY-078 selected by the Company for its upcoming clinical trials.
About SCYNEXIS
SCYNEXIS is a drug development company committed to the development and commercialization of novel anti-infectives to address significant unmet therapeutic needs. We are developing our lead product candidate, SCY-078, as an oral and IV drug for the treatment of several fungal infections, including serious and life-threatening invasive fungal infections. For more information, visit www.scynexis.com.
SOURCE: Scynexis
Post Views: 43
