SYNLOGIC


Associated tags: Genetic engineering, Gout, Synthetic biology, Probiotic, IBD, Inflammatory bowel disease, Roche, PKU, Homocystinuria, Phenylketonuria, HCU, Uric acid, AbbVie, Pharmaceutical industry, Therapy, Patient, FDA, Research

Locations: NEW YORK CITY, LOS ANGELES, INN, CULVER CITY, CA, CAMBRIDGE, MA, US, CALIFORNIA, UNITED STATES, ROCHE, BOSTON, CANADA

Synlogic To Present Three Data Presentations at the Society for Inherited Metabolic Disorders (SIMD) 44th Annual Meeting

Retrieved on: 
Tuesday, March 7, 2023
Synthetic biology, Doctor of Philosophy, Medical genetics, AbbVie, Publication, PKU, Methionine, Genetics, Caregiver, Homocystinuria, Society, HCU, Plasma, University, Annual general meeting, Research and development, SIMD, Therapy, Metabolism, Patient, University of Pittsburgh, Abstract, MD, UPMC, Pediatrics, Pharmaceutical industry, Research, Homocysteine

CAMBRIDGE, Mass., March 07, 2023 (GLOBE NEWSWIRE) -- Synlogic, Inc. (Nasdaq: SYBX), the leading company advancing therapeutics based on synthetic biology, today announced that it will present a podium presentation and two poster presentations at the Society for Inherited Metabolic Disorders (SIMD) 44th Annual Meeting in Salt Lake City, Utah on March 19, 2023.

Key Points: 
  • CAMBRIDGE, Mass., March 07, 2023 (GLOBE NEWSWIRE) -- Synlogic, Inc. (Nasdaq: SYBX), the leading company advancing therapeutics based on synthetic biology, today announced that it will present a podium presentation and two poster presentations at the Society for Inherited Metabolic Disorders (SIMD) 44th Annual Meeting in Salt Lake City, Utah on March 19, 2023.
  • Presenting author: Dr. Jerry Vockley, MD, PhD, Director, Center for Rare Disease Therapy, Chief, Medical Genetics at UPMC Children’s Hospital of Pittsburgh, Professor of Pediatrics and Human Genetics at University of Pittsburgh and lead investigator of Synlogic’s PKU Phase 2 Synpheny-1 study
    Poster Presentation #119: SYNB1353, A Proposed Therapy for Homocystinuria, Lowers Plasma Methionine and Homocysteine in Healthy Volunteers Exposed to a Methionine Challenge
    “We are delighted to have the opportunity to present further data for both the PKU and HCU programs at SIMD, with the leading experts in inborn errors of metabolism,” said Dr. Dave Hava, Chief Scientific Officer and Head of Research and Development at Synlogic.
  • "We recognize that PKU and HCU continue to cause tremendous burden to patients and caregivers, and we look forward to sharing data from these programs with the expert clinicians at this congress.”
    Following the presentations, all abstracts will be posted to the Publications page of the Synlogic website.

Synlogic Announces Participation in Upcoming Investor and Industry Conferences

Retrieved on: 
Tuesday, January 24, 2023
Conference, AbbVie, Synthetic biology, BIO, Therapy, Pharmaceutical industry

In addition, an on-demand video presentation will be available for conference participants during the event, and for approximately 30 days after the event.

Key Points: 
  • In addition, an on-demand video presentation will be available for conference participants during the event, and for approximately 30 days after the event.
  • SVB Securities Global Biopharma Conference: The Synlogic management team will participate in the SVB Securities Global Biopharma Conference 2023, being held virtually February 14-16, 2023.
  • Recorded presentations, if available, can be found on the Events section of the Synlogic website.
  • Archived versions of webcasts will also be available after the presentations on the Synlogic website.

Synlogic Receives Rare Pediatric Disease Designation from FDA for SYNB1934 for Phenylketonuria (PKU)

Retrieved on: 
Thursday, January 19, 2023
Phenylketonuria, News, AbbVie, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, PKU, FDA, Research and development, Homocystinuria, Food, Therapy, Patient, Synthetic biology, HCU, Pharmaceutical industry, Research

CAMBRIDGE, Mass., Jan. 19, 2023 (GLOBE NEWSWIRE) -- Synlogic, Inc. (Nasdaq: SYBX), the leading company advancing therapeutics based on synthetic biology, today announced that SYNB1934 was granted Rare Pediatric Disease Designation (RPDD) by the U.S. Food and Drug Administration (FDA) for the potential treatment of phenylketonuria (PKU).

Key Points: 
  • CAMBRIDGE, Mass., Jan. 19, 2023 (GLOBE NEWSWIRE) -- Synlogic, Inc. (Nasdaq: SYBX), the leading company advancing therapeutics based on synthetic biology, today announced that SYNB1934 was granted Rare Pediatric Disease Designation (RPDD) by the U.S. Food and Drug Administration (FDA) for the potential treatment of phenylketonuria (PKU).
  • “This designation for SYNB1934 demonstrates the urgent need for new PKU treatment options for patients, especially children,” said Dave Hava, Head of Research and Development.
  • “This is also extraordinary news as our program heads towards initiation of Synpheny-3, the pivotal Phase 3 study for SYNB1934 in PKU in the first half of the year.”
    Synlogic also received RPDD for SYNB1353 for the potential treatment of homocystinuria (HCU) in December 2022.

Synlogic Provides Corporate Update and Outlook for 2023

Retrieved on: 
Thursday, January 5, 2023
Synthetic biology, HCU, 4Q, Food, AbbVie, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Rinderpest, PKU, FDA, Pharmaceutical industry

CAMBRIDGE, Mass., Jan. 05, 2023 (GLOBE NEWSWIRE) -- Synlogic, Inc. (Nasdaq: SYBX), a clinical-stage biotechnology company developing medicines for metabolic and immunological diseases through its proprietary approach to synthetic biology, today summarized accomplishments for 2022 and outlined anticipated key milestones for 2023.

Key Points: 
  • CAMBRIDGE, Mass., Jan. 05, 2023 (GLOBE NEWSWIRE) -- Synlogic, Inc. (Nasdaq: SYBX), a clinical-stage biotechnology company developing medicines for metabolic and immunological diseases through its proprietary approach to synthetic biology, today summarized accomplishments for 2022 and outlined anticipated key milestones for 2023.
  • The Company is expected to begin its Phase 3 trial in PKU in the first half of this year.
  • In addition, SYNB1353 was granted Rare Pediatric Disease Designation (RPDD) by the U.S. Food and Drug Administration (FDA) for the potential treatment of HCU.
  • Synlogic will also report its 4Q and full year 2022 financial results in March 2023.

Synlogic Announces Appointment of Dr. Dave Hava as Head of Research and Development

Retrieved on: 
Tuesday, January 3, 2023
Synthetic biology, HCU, AbbVie, Gout, Science, Homocystinuria, Patient, Development, IND, Pharmaceutical industry, Research

CAMBRIDGE, Mass., Jan. 03, 2023 (GLOBE NEWSWIRE) -- Synlogic, Inc. (Nasdaq: SYBX), a clinical-stage biotechnology company developing medicines for metabolic and immunological diseases through its proprietary approach to synthetic biology, today announced the appointment of Dr. Dave Hava to Head of Research and Development effective January 1, 2023.

Key Points: 
  • “Developing a new therapeutic modality requires seamless integration of research and clinical development so that learnings from the clinic can be immediately applied to earlier programs,” said Aoife Brennan, M.B.
  • “Since joining the company, Dave has demonstrated the attributes required to take our programs and pipeline to the next level.
  • Dr. Hava joined Synlogic with 16 years of experience in the pharmaceutical industry leading platform and drug development programs, with roles including Chief Scientific Officer at Metera Pharmaceuticals and Pulmatrix Inc., where he led research, development, and clinical teams.
  • “Through our realigned structure, I’m excited to bring our research and development teams together in a cross-collaborative environment to better integrate our advanced pipeline across all stages of development,” said Dr. Hava.

Synlogic Announces Achievement of Proof of Concept for SYNB8802 in Enteric Hyperoxaluria Based on Urinary Oxalate Lowering in Phase 1b Study

Retrieved on: 
Thursday, December 15, 2022
Roche, Synthetic biology, Associate, Intellectual property, TID, HCU, Genetic engineering, Clinical trial, Inflammatory bowel disease, Kidney, PKU, Absorption, Urine, FDA, Uric acid, AES, Webcast, Safety, Roux-en-Y anastomosis, Diet, Homocystinuria, Pain, Gout, Phenylketonuria, Malabsorption, MD, Risk, Șaeș, University of Alabama at Birmingham School of Medicine, Associate professor, ID, History, IBD, University, Metabolism, Patient, Therapy, Probiotic, Pharmaceutical industry, Urology, AbbVie

CAMBRIDGE, Mass., Dec. 15, 2022 (GLOBE NEWSWIRE) -- Synlogic, Inc. (Nasdaq: SYBX), a clinical-stage biotechnology company developing medicines for metabolic and immunological diseases through its proprietary approach to synthetic biology, today announced that SYNB8802 has demonstrated proof of concept through clinically significant lowering of urinary oxalate in a Phase 1b study in patients with a history of gastric bypass surgery.

Key Points: 

    Synlogic Announces SYNB1353 Achieves Proof of Mechanism for Treatment of Homocystinuria and Provides Business Update

    Retrieved on: 
    Wednesday, November 30, 2022
    Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Probiotic, Risk, MAD, AbbVie, GI, Therapy, Roche, Synthetic biology, Homocystinuria, Inflammatory bowel disease, Phenylketonuria, Nature, Catastrophic optical damage, Șaeș, Blood, Patient, IBD, PKU, Genetic engineering, Gout, Fast Track, Workforce, Diet, Plasma, FDA, Methionine, Feces, Food, Uric acid, Urine, Ginkgo, Cystathionine, Disease, CBS, Orphan, Frequency, News, Research, AES, Clinical trial, Safety, Metabolism, AUC, Frank Lenti, Homocysteine, AE, Gastrointestinal tract, Absorption, ODD, Pharmaceutical industry, Risk management, Dietary supplement, Mineral wool, HCU

    CAMBRIDGE, Mass., Nov. 30, 2022 (GLOBE NEWSWIRE) -- Synlogic, Inc. (Nasdaq: SYBX), a clinical-stage biotechnology company developing medicines for metabolic and immunological diseases through its proprietary approach to synthetic biology, today announced that SYNB1353 has achieved proof of mechanism and positive results in a Phase 1 study in healthy volunteers treated with multiple ascending doses of SYNB1353.  SYNB1353 is an orally administered, non-systemically absorbed drug candidate designed to consume methionine in the GI tract for the potential treatment of homocystinuria (HCU). 

    Key Points: 
    • SYNB1353 is an orally administered, non-systemically absorbed drug candidate designed to consume methionine in the GI tract for the potential treatment of homocystinuria (HCU).
    • The Company also shared that the FDA has granted Orphan Drug Designation (ODD) to SYNB1353 for the treatment of HCU.
    • This dietary model was intended to capture in healthy volunteers a transient elevation in methionine following a meal challenge, in order to demonstrate proof of mechanism of consumption of methionine by SYNB1353.
    • Dosing of SYNB1353 resulted in a reduction in plasma methionine when measured over 24-hours as area under the curve (AUC) following a methionine meal challenge.

    Synlogic Reports Third Quarter 2022 Financial Results and Provides Business Update

    Retrieved on: 
    Thursday, November 10, 2022
    GLOBE, Private Securities Litigation Reform Act, Plasma, Probiotic, Intellectual property, Roche, Investment, Risk, Nasdaq, Synthetic biology, Inflammatory bowel disease, Homocystinuria, Phenylketonuria, IBD, U.S. Securities and Exchange Commission, Gout, Drug development, Uric acid, Clinical trial, Research, Patient, Genetic engineering, Therapy, PKU, HCU, Metabolism, Pharmaceutical industry, AbbVie

    CAMBRIDGE, Mass., Nov. 10, 2022 (GLOBE NEWSWIRE) -- Synlogic, Inc. (Nasdaq: SYBX), a clinical-stage biotechnology company developing medicines for metabolic and immunological diseases through its proprietary approach to synthetic biology, today reported financial results for the third quarter ended September 30, 2022 and provided an update on its pipeline programs.

    Key Points: 
    • Initiate the Phase 3 trial for SYNB1934 in PKU in H1 2023 with Phase 3 readiness activities currently underway.
    • Share data from the Phase 1 trial in healthy volunteers for SYNB1353 for HCU in 2022.
    • As of September 30, 2022, Synlogic had cash, cash equivalents and short-term investments of $91.7 million.
    • However, while Synlogic may elect to update these forward-looking statements in the future, Synlogic specifically disclaims any obligation to do so.

    Synlogic Announces Positive Top-Line Phase 2 Data for Phenylketonuria (PKU); SYNB1934 Advances to Phase 3

    Retrieved on: 
    Tuesday, October 18, 2022
    European Medicines Agency, Genetics, Lists of diseases, U.S. Securities and Exchange Commission, Disease, Therapy, Webcast, Investor, HCU, US Foods, University of Pittsburgh, Roche, Patient, Synthetic biology, Homocystinuria, Uric acid, Genetic engineering, Pittsburgh, Allergy, Nasdaq, Private Securities Litigation Reform Act, University, Neurotoxicity, Probiotic, Food, Șaeș, Fasting, Nature, IBD, Incidence, Safety, Human genetics, AUC, Overalls, GLOBE, Gout, Clinical trial, Plasma, Diet, Intellectual property, Inflammatory bowel disease, PKU, Phenylketonuria, Metabolism, FDA, Risk, Milk, Pharmaceutical industry, Vaccine, PHE, AbbVie

    CAMBRIDGE, Mass., Oct. 18, 2022 (GLOBE NEWSWIRE) -- Synlogic, Inc. (Nasdaq: SYBX), a clinical-stage biotechnology company developing medicines for metabolic and immunological diseases through its proprietary approach to synthetic biology, today announced positive top-line data from the Phase 2 Synpheny-1 study in phenylketonuria (PKU). The company also confirmed that based on the results, SYNB1934 will be the drug candidate progressing to the Phase 3 registrational study expected to begin in H1 2023.  

    Key Points: 
    • The Phase 2 study enrolled 20 patients with PKU; 11 were enrolled in the SYNB1618 arm and 9 patients were enrolled in the SYNB1934 arm.
    • We are tremendously excited to share these top-line data from our Phase 2 study showing consistent positive results across all endpoints in patients with PKU.
    • The Phase 2 Synpheny-1 study is a Phase 2, open-label, 28-day study to assess safety, tolerability and efficacyof SYNB1618 and SYNB1934 in patients with PKU.
    • However, while Synlogic may elect to update these forward-looking statements in the future, Synlogic specifically disclaims any obligation to do so.

    Synlogic Reports Positive Top-line Data from Phase 1/2a Study of SYNB1618 in Patients with Phenylketonuria and Guides to Next Phase of Development

    Retrieved on: 
    Monday, July 15, 2019
    Biotechnology, Health, Pharmaceutical, Clinical trials, Rare diseases, Medicine, Clinical medicine, Intellectual disability, Newborn screening, Phenylketonuria, RTT, Health, Pyrimidines, the Phase 1/2a Trial Design, Phenylketonuria (PKU), Synlogic

    These data in PKU patients demonstrate that SYNB1618 was well-tolerated by patients and provide a clear path forward for the program.

    Key Points: 
    • These data in PKU patients demonstrate that SYNB1618 was well-tolerated by patients and provide a clear path forward for the program.
    • In this bridging study, Synlogic plans to select optimal doses of SYNB1618 for an efficacy study in patients with PKU designed to evaluate blood Phe-lowering.
    • Synlogic has developed a robust and reproducible process and manufactured a new solid formulation of SYNB1618 that maintains strain viability and activity.
    • Synlogics Phase 1/2a trial was a randomized, double-blind, placebo-controlled study of an orally administered early liquid formulation of SYNB1618.