On January 3, 2019 Synlogic, Inc. (Nasdaq: SYBX), a clinical-stage drug discovery and development company applying synthetic biology to beneficial microbes to develop novel living medicines, reported an overview of recent progress and outlined key objectives and anticipated milestones for 2019 (Press release, Synlogic, JAN 3, 2019, View Source [SID1234532396]).
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"2018 was a significant year for Synlogic as we advanced our two lead clinical programs and platform. We have demonstrated proof of mechanism in both programs in healthy volunteers and are currently evaluating safety and activity in patients with disease. In addition, we broadened our pipeline with the addition of our first immuno-oncology development candidate, SYNB1891," said Aoife Brennan, M.B. Ch.B., Synlogic’s president and chief executive officer. "In 2019 we look forward to presenting data from our two ongoing clinical programs that will inform the development of our Synthetic Biotic platform. With the recent expansion of our internal GMP-manufacturing capabilities, we are well positioned to maintain the momentum of the past year and continue to advance programs through clinical development as expeditiously as possible."
2019 Goals and Catalysts
Pipeline
SYNB1020: An orally delivered, first-in-class, Synthetic Biotic medicine designed for treatment of elevated blood ammonia levels (hyperammonemia) in chronic liver disease or genetic urea cycle disorders (UCDs).
In mid-2019, Synlogic expects to present top-line data from its randomized, double-blind, placebo -controlled Phase 1b/2a clinical trial evaluating SYNB1020 in patients with cirrhosis and elevated ammonia. The main endpoints of the study are safety and tolerability, as well as evidence of ammonia lowering in patients.
SYNB1618: An orally delivered, Synthetic Biotic medicine designed for the treatment of phenylketonuria (PKU).
In mid-2019, Synlogic expects to present top-line data from its randomized, double-blind, placebo-controlled Phase 1/2a clinical trial evaluating SYNB1618 in patients with PKU. The study is designed to evaluate safety and tolerability in this population as well as pharmacokinetics and pharmacodynamics as determined by the production of biomarkers specifically associated with SYNB1618 activity.
SYNB1891: Synlogic’s first immuno-oncology (IO) development candidate, a STING agonist-producing Synthetic Biotic medicine, designed to act as a dual innate immune activator, for the treatment of non-immunologically responsive solid tumors.
In the second half of 2019 the Company expects to file an IND application to enable advancement of SYNB1891 into a Phase 1 clinical study.
Pre-clinical data and early pipeline programs:
The company expects to publish and present data at major scientific and medical meetings throughout the year demonstrating the breadth and potential of its Synthetic Biotic platform.
Synlogic and AbbVie will continue to advance their ongoing collaboration to develop a Synthetic Biotic medicine for the treatment of inflammatory bowel disease (IBD).
Corporate
Synlogic ended the third quarter of 2018 with $133 million in cash and cash equivalents and expects that this will fund Company operations through 2020 under its current plan.
The Company will continue to explore additional strategic opportunities to expand the reach of its Synthetic Biotic platform.
2018 Accomplishments and Highlights:
Pipeline
SYNB1020:
Dosed first patient in Phase 1b/2a trial of SYNB1020 for the treatment of hyperammonemia in patients with cirrhosis and elevated ammonia. The clinical trial is a single and multiple dose-escalation, randomized, double-blind, placebo-controlled study of orally administered SYNB1020 in patients with cirrhosis and elevated blood ammonia, designed to evaluate safety, tolerability, kinetics, and pharmacodynamics as well as the ability of SYNB1020 to lower blood ammonia. Synlogic enrolled and treated an initial open-label sentinel cohort of six subjects with mild disease to ensure that SYNB1020 was safe in patients with liver disease who often have compromised barrier function and might be susceptible to infection. This part of the study is complete and Synlogic is enrolling patients with more advanced disease with elevated blood ammonia at baseline.
Presented data supporting continued development of SYNB1020 for the treatment of liver disease at the annual meeting of the American Association for the Study of Liver Diseases (AASLD). Synlogic presented data from a cross-sectional study designed to establish ammonia measurement parameters and ammonia levels in healthy volunteers at clinical sites that are participating in Synlogic’s ongoing Phase 1b/2a clinical trial of SYNB1020 in patients with cirrhosis and elevated ammonia. Preclinical data from a rat model were also presented by Synlogic’s collaborators that demonstrated dose-dependent lowering of blood ammonia by Synthetic Biotic strains designed to consume ammonia, confirming earlier preclinical observations in mouse models of liver disease.
SYNB1618:
Announced positive interim data from the healthy volunteer arm of its ongoing Phase 1/2a clinical trial evaluating SYNB1618 for the treatment of PKU. The data demonstrated a statistically significant, dose-dependent effect on treatment-associated biomarkers, indicating proof-of-mechanism, and also established a go-forward dose for the treatment arm in patients with PKU.
Published preclinical data in Nature Biotechnology identifying key biomarkers of SYNB1618 activity in healthy animal and disease models. The data demonstrated that oral administration of SYNB1618 significantly reduced blood phenylalanine (Phe) levels, the key metabolite associated with PKU, in mouse models of PKU and resulted in dose-dependent pharmacodynamics in healthy non-human primates (NHPs).
Fast Track designation granted to SYNB1618 for PKU by the U.S. Food and Drug Administration (FDA).
SYNB1891:
Presented preclinical data highlighting the potential of Synthetic Biotic medicines in IO and announced first IO clinical candidate at the annual meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper). A webcast of the presentation is available on the Synlogic website. Data presented at the meeting demonstrate the platform’s potential for the treatment of cancer and inflammation and specifically highlight the unique advantages of Synlogic’s approach to stimulate the innate immune system.
Corporate
Successfully completed two public offerings of common stock in January and April, resulting in approximately $83 million in total net proceeds.
The Company announced executive leadership changes including the appointment of Aoife Brennan, M.B., B.Ch., as president and chief executive officer, and the appointment of Antoine Awad as Head of Technical Operations.
Synlogic expanded its manufacturing capabilities to enable production of clinical trial material for its oral and immuno-oncology programs via entry into an agreement to lease GMP clean-room space from the Azzur Group, LLC. The agreement provides the Company with infrastructure that enables advancement of clinical programs through early and mid-phase studies and supports the production of both solid and oral formulations.
Advanced collaboration with AbbVie to develop Synthetic Biotic-based treatments for IBD resulting in payment to Synlogic of a $2.0 million milestone.
Synlogic was added to both the Russell 3000Index and the NASDAQ Biotechnology Index (Nasdaq: NBI).