Cystathionine

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

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Monday, March 20, 2023
DSM-IV codes, Society, University of Pittsburgh, University, Pediatrics, Therapy, Phenylketonuria, SIMD, Aes, Adverse, AbbVie, Publication, Biomarker, Doctor of Philosophy, CBS, PKU, Research and development, Homocysteine, Plasma, Homocystinuria, Genetics, HCU, MD, Patient, Nature, Met, Annual general meeting, HCY, Extrapyramidal system, UPMC, Cystathionine, Synthetic biology, Medical genetics, Pharmaceutical industry, Dietary supplement, Research

In separate poster presentations, the company also presented clinical data and preclinical data related to its homocystinuria (HCU) program.

Key Points: 
  • In separate poster presentations, the company also presented clinical data and preclinical data related to its homocystinuria (HCU) program.
  • “We were delighted to review these encouraging findings from our two rare metabolic disease programs among the expert metabolic clinicians who attend the SIMD meeting,” said Dave Hava, Chief Scientific Officer and Head of Research and Development at Synlogic.
  • Clinical data presented included positive data from the Phase 1 study evaluating SYNB1353 in healthy volunteers using a dietary model of HCU.
  • Posters presented at the SIMD meeting are posted on the Publications page of the Synlogic website.

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

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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.

Aeglea BioTherapeutics Announces Presentations at the Society for the Study of Inborn Errors of Metabolism (SSIEM) Annual Symposium 2022

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Monday, August 29, 2022
HCU, Enzyme, Protalix BioTherapeutics, Safety, Arginase, Lists of diseases, NASDAQ, Engineering, Cystathionine, Emory University School of Medicine, Arginine, Multimedia, Therapy, Society, Patient, CBS, Pharmaceutical industry, Tutoring, Homocystinuria, MD, Metabolism

AUSTIN, Texas, Aug. 29, 2022 /PRNewswire/ --Aeglea BioTherapeutics, Inc. (NASDAQ: AGLE), a clinical-stage biotechnology company developing a new generation of human enzyme therapeutics to benefit people with rare metabolic diseases, today announced oral and poster presentations at the Society for the Study of Inborn Errors of Metabolism (SSIEM) Annual Symposium 2022 being held in Freiburg, Germany August 30 September 2.

Key Points: 
  • AUSTIN, Texas, Aug. 29, 2022 /PRNewswire/ --Aeglea BioTherapeutics, Inc. (NASDAQ: AGLE), a clinical-stage biotechnology company developing a new generation of human enzyme therapeutics to benefit people with rare metabolic diseases, today announced oral and poster presentations at the Society for the Study of Inborn Errors of Metabolism (SSIEM) Annual Symposium 2022 being held in Freiburg, Germany August 30 September 2.
  • Aeglea is investigating AGLE-177 in an ongoing Phase 1/2 clinical trial for the treatment of Homocystinuria.
  • Aeglea's other clinical program, pegzilarginase, achieved the primary endpoint of arginine reduction in the PEACE Phase 3 clinical trial and has received both Rare Pediatric Disease and Breakthrough Therapy Designations.
  • Aeglea has an active discovery platform focused on engineering small changes in human enzymes to have a big impact on the lives of patients and their families.

Codexis Announces FDA Orphan Drug and Rare Pediatric Disease Designations for CDX 6512 for the Treatment of Homocystinuria

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Monday, January 24, 2022
Ageing, Synthetic biology, Cystathionine, HCU, Stroke, Person, Stomach, Private Securities Litigation Reform Act, Pyridoxine, SEC, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Intellectual, Enzyme, Homocystinuria, Homocysteine, NASDAQ, CEO, Learning, ODD, GLOBE, Human services, International Congress on Tuberculosis, GARD, Department, Methionine, Health, U.S. Securities and Exchange Commission, Urine, United States Department of Health and Human Services, MTHFR, CBS, Marketing, Program, Cardiovascular disease, Company, Betaine, Diagnosis, Disorder, RPD, Food, Therapy, Blood, FDA, Genetic, Osteoporosis, Security (finance), Annual report, Pharmaceutical industry, Dietary supplement, Metabolism, Codexis

The FDA also granted the company rare pediatric disease (RPD) designation for CDX-6512.

Key Points: 
  • The FDA also granted the company rare pediatric disease (RPD) designation for CDX-6512.
  • CDX-6512 is currently in pre-IND development and is the most advanced wholly owned program in the Companys biotherapeutics pipeline.
  • The orphan drug and rare pediatric disease designations for CDX-6512 further build upon the momentum our engineered enzymes have generated as potential first-in-class oral therapeutics for inborn errors of metabolism, said John Nicols, President and CEO of Codexis.
  • These designations represent an important step forward in the development of CDX-6512 as a potential treatment of homocystinuria and we look forward to continuing its advancement toward the clinic.

Aeglea BioTherapeutics Announces Approval of Clinical Trial Application for its Novel Engineered Human Enzyme Designed to Treat Homocystinuria (ACN00177)

Retrieved on: 
Wednesday, April 8, 2020
Enzymes, Homocystinuria, MHRA, Medicines and Healthcare products Regulatory Agency, Cystathionine beta synthase, Cystathionine, Homocysteine

Aeglea is developing ACN00177 for the treatment of patients with cystathionine beta synthase (CBS) deficiency, also known as Classical Homocystinuria.

Key Points: 
  • Aeglea is developing ACN00177 for the treatment of patients with cystathionine beta synthase (CBS) deficiency, also known as Classical Homocystinuria.
  • ACN00177 has been designed as a novel recombinant human enzyme, which degrades the amino acid homocysteine and its related homocystine dimer.
  • In April 2020, Aeglea announced that the United KingdomsMedicines and Healthcare Products Regulatory Agency(MHRA) approved the Companys Clinical Trial Application.
  • The Companys Clinical Trial Application (CTA) for ACN00177 for Homocystinuria has been approved by the United Kingdoms Medicines and Healthcare Products Regulatory Agency (MHRA).

Aeglea BioTherapeutics Reports Fourth-Quarter and Full-Year 2019 Financial Results, Highlights Recent Milestones

Retrieved on: 
Monday, February 24, 2020
Enzymes, Homocystinuria, Cystathionine beta synthase, Cystathionine

Research and development expenses totaled $17.6 million for the fourth quarter of 2019 and $11.8 million for the fourth quarter of 2018.

Key Points: 
  • Research and development expenses totaled $17.6 million for the fourth quarter of 2019 and $11.8 million for the fourth quarter of 2018.
  • General and administrative expenses totaled $4.3 million for the fourth quarter of 2019 and $3.5 million for the fourth quarter of 2018.
  • Aeglea is developing ACN00177 for the treatment of patients with cystathionine beta synthase (CBS) deficiency, also known as Classical Homocystinuria.
  • Aeglea BioTherapeutics is a clinical-stage biotechnology company redefining the potential of human enzyme therapeutics to address rare and other high burden diseases with unmet medical need.

Aeglea BioTherapeutics Submits CTA Application for its Novel Engineered Human Enzyme Designed to Treat Homocystinuria (ACN00177)

Retrieved on: 
Monday, January 13, 2020
Enzymes, Homocystinuria, Homocysteine, Cystathionine beta synthase, Cystathionine, Homocystine, Hyperhomocysteinemia, Transsulfuration pathway

Currently, people diagnosed with homocystinuria face a debilitating chronic disease, poor quality of life and inadequate treatments, including severe lifelong dietary restrictions, said Anthony G. Quinn, M.B.

Key Points: 
  • Currently, people diagnosed with homocystinuria face a debilitating chronic disease, poor quality of life and inadequate treatments, including severe lifelong dietary restrictions, said Anthony G. Quinn, M.B.
  • "Aegleas innovative platform has engineered a novel enzyme which, by reducing plasma homocysteine levels, has the potential to transform the patient experience with this challenging disease.
  • Aeglea is developing ACN00177 for the treatment of patients with cystathionine beta synthase (CBS) deficiency, also known as Classical Homocystinuria.
  • ACN00177 has been designed as a novel recombinant human enzyme, which degrades the amino acid homocysteine and its related homocystine dimer.