8, 2017– Synlogic, Inc.,(Nasdaq: SYBX) a clinical-stage drug discovery and development company applying synthetic biology to probiotics to develop novel Synthetic Biotic medicines, today announced positive top-line clinical data from its Phase 1 placebo-controlled single (SAD) and multiple ascending dose (MAD) clinical trial of SYNB1020 in healthy volunteers.The trial successfully met the primary objectives demonstrating safety and tolerability in healthy volunteers and identifying the maximum tolerated dose.In one week managers might need to hire staff to accommodate an intimate black-tie dinner party for 30 diners, a 3,000-person corporate event and a promotional cocktail hour for 300 people.Finding talented workers during busy periods, retaining them during slow periods, is both stressful and time consuming.In the MAD component of the Phase 1 study, daily dosing of SYNB1020 over 14 days in healthy volunteers enabled identification of a dose-response relationship between SYNB1020 oral administration and changes in a nitrogen endpoint in plasma which was found to be statistically significant in the highest dose cohort compared to placebo.In addition, viability and evidence of mechanistic activity of the Synthetic Biotic was demonstrated in feces of subjects who received SYNB1020, but not in control subjects.Furthermore, proof of mechanism was demonstrated by a clear signal in a plasma nitrogen endpoint. “These data support the hypothesis that SYNB1020 treatment may provide clinical benefit in patients with UCDs or liver disease, and will inform dose selection in our planned Phase 1b/2a study of SYNB1020 in patients, which we expect to begin in the first half of 2018.” “This first-in-human study represents a significant milestone for our new class of Synthetic Biotic medicines and demonstrates that they can operate from the gastrointestinal tract to metabolize systemic toxins,” said JC Gutiérrez-Ramos, Ph.
Part one of the study will enroll up to 20 patients in each of two dose cohorts: 500mg/m2 and 750mg/m2.
The shares commenced trading on the NASDAQ Global Select Market under the ticker symbol “APLS” on Thursday, November 9, 2017. A registration statement relating to the securities sold in this offering was declared effective by the Securities and Exchange Commission on November 8, 2017.
The offering was made only by means of a prospectus.
These data, which will be highlighted later today in a poster presentation (Poster #335) at the 32ND Annual Meeting of the Society for Immunotherapy of Cancer (SITC), underscore the potential application of ADU-1604 for the treatment of multiple cancer types, either as monotherapy or in combination with other therapies.
“These data from preclinical studies of ADU-1604, a novel anti-CTLA-4 product candidate derived from our proprietary B-select antibody platform, are encouraging and provide support to file an Investigational New Drug Application to advance ADU-1604 into clinical studies,” stated Andrea van Elsas, Ph. “As a company with multiple programs and proprietary technology platforms, we are well positioned to leverage our product candidates, as monotherapies and in rational combinations, to develop new treatment options for patients in need.” CAMBRIDGE, Mass.–(BUSINESS WIRE)–Nov.