Quarterly report pursuant to Section 13 or 15(d)

Subsequent Events

v3.20.2
Subsequent Events
6 Months Ended
Jun. 30, 2020
Subsequent Events  
Subsequent Events

12. Subsequent Events

On June 30, 2020 the Company submitted an Investigational New Drug (IND) application with the FDA for SYN-020, an oral formulation of recombinant intestinal alkaline phosphatase (IAP). On July 30, 2020 the Company announced that it received a study-may-proceed letter from the U.S. Food and Drug Administration (FDA) to conduct a Phase 1 single ascending dose study in healthy volunteers designed to evaluate SYN-020 for safety, tolerability and pharmacokinetic parameters. The Phase 1 clinical program is intended to support the clinical development of SYN-020 in multiple indications, including the treatment of radiation enteropathy secondary to pelvic cancer therapy.

On January 7, 2020 the Company held a Type-C meeting with the FDA to discuss the clinical program requirements needed to evaluate safety, tolerability and potential absorption into the systemic circulation (if any) of SYN-004 (ribaxamase) in adult allogeneic HCT recipients. On July 30, 2020 the Company received written notification from the FDA informing it that they determined the Phase 1b/2a clinical program in adult allogeneic HCT recipients is safe to proceed per the submitted clinical program protocol.