Phenylalanine

Eton Pharmaceuticals Announces Acquisition of PKU GOLIKE® for Phenylketonuria

Retrieved on: 
Friday, March 22, 2024
Brain, Taste, Nitisinone, Partnership, Education, Patient, PKU, Phenylalanine, DSM-IV codes, Insurance, Protein, APR, Diet, Homocystinuria, Patent, OTCQB, FDA, Practitioner, Pharmaceutical industry

After extensive discussions with metabolic geneticists, dieticians, and PKU patients, we believe PKU GOLIKE is the best product in the estimated $100 million U.S. PKU medical formula market.

Key Points: 
  • After extensive discussions with metabolic geneticists, dieticians, and PKU patients, we believe PKU GOLIKE is the best product in the estimated $100 million U.S. PKU medical formula market.
  • PKU GOLIKE’s taste-masked, odor-free coating technology is designed to provide a better taste and a superior experience compared to alternative PKU medical formulas.
  • Relief launched PKU GOLIKE Granules in the United States in the fourth quarter of 2022 and the PKU GOLIKE Tropical Bar in the second quarter of 2023.
  • Eton plans to promote PKU GOLIKE with its existing metabolic sales force, which currently promotes Eton’s Carglumic Acid, Betaine, and Nitisinone products.

Eton Pharmaceuticals Announces Commercial Availability of Ultra-Rare Disease Product Nitisinone Capsules

Retrieved on: 
Friday, February 2, 2024
Partnership, Conjunctivitis, Medicine, Inflammation, Vitamin, Thrombocytopenia, Immune system, Tyrosine, Patient, Light, Nosebleed, Intellectual disability, Itch, Ageing, Diet, Keratitis, Skin, Pharmacy, Tongue, Rash, DSM-IV codes, Allergy, Blood, Leukopenia, Photophobia, Mouth ulcer, Phenylalanine, Erythroderma, Tell, Insurance, Face, Breast milk, Plasma, Nursing

DEER PARK, Ill., Feb. 02, 2024 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals (“Eton” or “the Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing, acquiring, and commercializing products to address unmet needs in patients suffering from rare diseases, today announced the commercial availability of Nitisinone Capsules for the treatment of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. Please see important safety information below. Tyrosinemia type 1 is an ultra-rare condition that is estimated to impact fewer than 500 patients in the United States.

Key Points: 
  • We believe that our existing commercial infrastructure and strong patient support services should help us capture a meaningful percentage of the estimated $50 million annual Nitisinone market,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals.
  • Nitisinone Capsules are available exclusively through Optime Care, a specialty pharmacy dedicated to helping patients with rare diseases manage their conditions.
  • Optime Care will administer the Eton Cares Program in partnership with Eton Pharmaceuticals.
  • To report a suspected adverse event related to Nitisinone, contact Eton Pharmaceuticals, Inc. at: 1-855-224-0233 or the US Food and Drug Administration at www.fda.gov/medwatch or call 1-800-FDA-1088.

Jnana Therapeutics Announces Positive Clinical Proof of Concept Achieved with JNT-517, a Potential First-in-Class Oral Treatment for PKU

Retrieved on: 
Tuesday, January 30, 2024
RAPID, Pharmacokinetics, SLC6A19, Phenylketonuria, BID, Trial of the century, Safety, Medical genetics, Ageing, Jñāna, Blood, Disease, Therapy, Science, Phenylalanine, PKU, Pharmaceutical industry

BOSTON, Jan. 30, 2024 (GLOBE NEWSWIRE) -- Jnana Therapeutics, a clinical-stage biotechnology company leveraging its next-generation chemoproteomics platform to discover medicines for challenging-to-drug targets, today announced positive, statistically significant interim results from its ongoing clinical study of JNT-517 in individuals with phenylketonuria (PKU). JNT-517, a small molecule inhibitor of the phenylalanine (Phe) transporter SLC6A19, is being evaluated as a potential first-in-class oral treatment for PKU across all ages and genotypes. On the basis of these positive interim results, Jnana has adapted the Phase 1b trial design to support the potential for accelerated progression of JNT-517.

Key Points: 
  • JNT-517, a small molecule inhibitor of the phenylalanine (Phe) transporter SLC6A19, is being evaluated as a potential first-in-class oral treatment for PKU across all ages and genotypes.
  • On the basis of these positive interim results, Jnana has adapted the Phase 1b trial design to support the potential for accelerated progression of JNT-517.
  • “There is an urgent need for an oral, safe, and efficacious therapy for the more than 60% of individuals with PKU not currently on therapy.
  • The study dosed its first participant with PKU in August 2023 and is enrolling individuals aged 18 to 65 at clinical sites in the United States and Australia.

Synlogic Provides Corporate Update and Outlook for 2024

Retrieved on: 
Thursday, January 4, 2024
Conference, Food, AbbVie, Met, Nature Metabolism, Homocysteine, FDA, Plasma, DMC, Annual general meeting, Diet, Ageing, Trial of the century, Society, GI, Data monitoring committee, Phenylalanine, Part, SIMD, PKU, HCU, Patient, Safety, Pharmaceutical industry

CAMBRIDGE, Mass., Jan. 04, 2024 (GLOBE NEWSWIRE) -- Synlogic, Inc. (Nasdaq: SYBX), a clinical-stage biotechnology company advancing novel, oral, non-systemically absorbed biotherapeutics to transform the care of serious diseases, today summarized accomplishments for 2023 and anticipated key milestones for 2024.

Key Points: 
  • “We are pleased with the important corporate progress we achieved in 2023 - highlighted by the initiation of our global pivotal Synpheny-3 study evaluating our potentially transformative treatment option for PKU,” said Aoife Brennan, M.B.
  • Ch.B., Synlogic President and Chief Executive Officer.
  • “We expect 2024 to be similarly momentous, with the achievement of key milestones, including the upcoming Data Monitoring Committee review of initial study data.
  • More information on the Synpheny-3 study is available at www.clinicaltrials.gov, identifier NCT05764239 and also by visiting pkuresearchstudy.com.

Eton Pharmaceuticals Announces Acquisition of FDA-Approved Ultra-Rare Disease Product Nitisinone

Retrieved on: 
Wednesday, October 4, 2023
Insurance, Cornea, Keratitis, US Foods, Tyrosine, Diet, Medicine, Tell, Face, Chapter 11, Title 11, United States Code, Erythroderma, Skin, Light, DSM-IV codes, Inflammation, Carglumic acid, Mouth ulcer, Rash, Phenylalanine, Intellectual disability, Eton, Plasma, Vitamin, Hair, Photophobia, Allergy, Patient, Leukopenia, Blood, Itch, Immune system, Cover My Eyes (Pain and Heaven), Ageing, Rare, FDA, Conjunctivitis, Nosebleed, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Thrombocytopenia, Tongue, Food, Breast milk, Pharmaceutical industry, Nursing, Dietary supplement, Medical imaging, Birth control, Nitisinone

DEER PARK, Ill., Oct. 04, 2023 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals (“Eton” or “the Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing, acquiring, and commercializing products to address unmet needs in patients suffering from rare diseases, today announced it has entered into an agreement to acquire an abbreviated new drug application for Nitisinone Capsules via Oakrum Pharma, LLC’s Chapter 11 bankruptcy proceeding. The transaction has been approved by the bankruptcy court and is expected to be effective on October 12, 2023. The acquired product was approved by the U.S. Food and Drug Administration (FDA) in May of 2023 for the treatment of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. It is estimated that less than 500 patients in the United States suffer from this ultra-rare condition.

Key Points: 
  • Nitisinone is our fourth FDA-approved product, and further advances us toward our goal of having ten commercial rare disease products on the market by the end of 2025.
  • Eton expects to launch the product in the first quarter of 2024 and plans to offer its Eton Cares support program to all patients.
  • Nitisinone is a prescription medicine used to treat adults and children with a hereditary disease called tyrosinemia type 1 (HT-1).
  • To report a suspected adverse event related to Nitisinone, contact Eton Pharmaceuticals, Inc. at: 1-855-224-0233 or the US Food and Drug Administration at www.fda.gov/medwatch or call 1-800-FDA-1088.

Hemp, Inc. Reports: Growing Legalization of Industrial Hemp Driving Global Demand for Hemp

Retrieved on: 
Thursday, September 28, 2023
CBDA, Valine, Food, Diet, Methionine, Lysine, Seed, Paint, Leucine, Threonine, Clothing, Cannabinoid, Absorption, Dicarboxylic acid, CBG, Phenylalanine, CBN, Tryptophan, Plant, Investment, OTC, Histidine, Coffee, Paper, Health, Textile, CBGA, Isoleucine, Rest, Dietary supplement, Hemp, CBD

LAS VEGAS, NV, Sept. 28, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire - Hemp, Inc. (OTC PINK: HEMP) is perfectly positioned at the forefront of the industrial hemp industry as demand increases and opportunities abound.

Key Points: 
  • LAS VEGAS, NV, Sept. 28, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire - Hemp, Inc. (OTC PINK: HEMP) is perfectly positioned at the forefront of the industrial hemp industry as demand increases and opportunities abound.
  • The recent release of a comprehensive research report, Global Industrial Hemp Market (2023-2031) , says the global industrial hemp market is forecast to grow to $134.6 billion by 2030.
  • As one of the most rapidly growing plants on the planet, hemp is used to make a variety of products.
  • With the “growing legalization of industrial hemp farming around the world, the demand for industrial hemp has been exponential.

ZXCHEM USA presents Revolutionary New Manufacturing Process for Plant Proteins in the US and Canadian Markets

Retrieved on: 
Wednesday, September 6, 2023
Valine, RTD, Food, Methionine, Lysine, Ice cream, Leucine, Enzyme, Threonine, Nutrient, Cheese, Multimedia, Dicarboxylic acid, Phenylalanine, Economic methodology, Milk, Tryptophan, Protein, Pesticide, PDCAAS, Water, Yogurt, Pea protein, Spray drying, Histidine, Protein Digestibility Corrected Amino Acid Score, Isoleucine, Fine chemical, Dairy, Dietary supplement

We are excited to offer them in the US and Canadian markets for the first time," says Wade Zheng, President of ZXCHEM USA.

Key Points: 
  • We are excited to offer them in the US and Canadian markets for the first time," says Wade Zheng, President of ZXCHEM USA.
  • HydroRice™ PA80 is 100% rice protein while HydroPR™ 80 is a 40/60 blend of rice and pea protein.
  • Both products are manufactured with a revolutionary new process that does not use enzymes or hydrolyzation to change the protein functionality.
  • Anhui Shunxin has assigned ZXCHEM USA as the exclusive distributor for the US and Canadian markets.

Jnana Therapeutics Presents Additional Data from Phase 1a Clinical Study of JNT-517 at SSIEM Annual Symposium

Retrieved on: 
Thursday, August 31, 2023
Science, Society, Phenylketonuria, Aminoaciduria, Pharmacokinetics, SLC6A19, RAPID, SAD, Jñāna, Dicarboxylic acid, DSM-IV codes, PKU, Phenylalanine, Plasma, Oregon Health & Science University, Oregon Health & Science University School of Dentistry, BID, MAD, Ageing, Medical genetics, Therapy, Safety, Pharmaceutical industry, Vaccine, Copper, Metabolism

BOSTON, Aug. 31, 2023 (GLOBE NEWSWIRE) -- Jnana Therapeutics, a clinical-stage biotechnology company leveraging its next-generation chemoproteomics platform to discover medicines for challenging-to-drug targets, today announced that additional data from its Phase 1a clinical trial of JNT-517 in healthy volunteers were presented at the Society for the Study of Inborn Errors of Metabolism (SSIEM) Annual Symposium 2023. JNT-517 is a first-in-class, oral, allosteric inhibitor of the phenylalanine (Phe) transporter SLC6A19 that Jnana is developing for the treatment of phenylketonuria (PKU). The data were presented by Cary O. Harding, M.D., study investigator and Professor of Molecular and Medical Genetics at Oregon Health and Science University School of Medicine.

Key Points: 
  • JNT-517 is a first-in-class, oral, allosteric inhibitor of the phenylalanine (Phe) transporter SLC6A19 that Jnana is developing for the treatment of phenylketonuria (PKU).
  • The data were presented by Cary O. Harding, M.D., study investigator and Professor of Molecular and Medical Genetics at Oregon Health and Science University School of Medicine.
  • The Phase 1a study enrolled 64 healthy adults in a randomized, double-blind, placebo-controlled trial to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of JNT-517 across single (SAD) and multiple (MAD) ascending dose cohorts.
  • The ongoing Phase 1b study will assess the impact of JNT-517 on plasma Phe levels in individuals with PKU.

ibex Sponsors the 2023 Creighton Farms Invitational Hosted by Jack Nicklaus

Retrieved on: 
Wednesday, August 23, 2023
Organic, Diet, Life, Quality of life, Research, PKU, Phenylalanine, Hospital, Jack Nicklaus, California Health Care Foundation, Blood, BPO, Diagnosis, Dietary supplement, Nursing, Phenylketonuria

WASHINGTON, Aug. 23, 2023 (GLOBE NEWSWIRE) -- ibex (NASDAQ: IBEX), a leading global provider of business process outsourcing (BPO) and customer engagement technology solutions, today announced its sponsorship of the 2023 Creighton Farms Invitational on August 27-28 at Creighton Farms in Aldie, VA.

Key Points: 
  • WASHINGTON, Aug. 23, 2023 (GLOBE NEWSWIRE) -- ibex (NASDAQ: IBEX), a leading global provider of business process outsourcing (BPO) and customer engagement technology solutions, today announced its sponsorship of the 2023 Creighton Farms Invitational on August 27-28 at Creighton Farms in Aldie, VA.
  • The 2023 Creighton Farms Invitational will benefit the Nicklaus Children’s Health Care Foundation and the PKU Hope Foundation.
  • The PKU Hope Foundation was founded by Creighton Farms members Jerry and Jill Elkins, whose son Hudson was born in 2013 with PKU (Phenylketonuria).
  • ibex Cares expects to donate more than $250,000 to local charities and disaster relief this year.

Jnana Therapeutics Announces Dosing of First Participant in Phase 1b Clinical Trial of JNT-517 in Individuals with PKU

Retrieved on: 
Wednesday, August 9, 2023
Partnership, Society, Senior, Phenylketonuria, Tolerability, Quality of life, Pharmacokinetics, Jñāna, CMO, PKU, Phenylalanine, Plasma, Oregon Health & Science University, Oregon Health & Science University School of Dentistry, Ageing, Medical genetics, Health, Therapy, Treatment, Safety, Pharmaceutical industry, Metabolism, SLC6A19

BOSTON, Aug. 09, 2023 (GLOBE NEWSWIRE) -- Jnana Therapeutics, a clinical-stage biotechnology company leveraging its next-generation chemoproteomics platform to discover medicines for challenging-to-drug targets, today announced that the first participant has been dosed in its Phase 1b clinical trial of JNT-517 in individuals with phenylketonuria (PKU). JNT-517 is a small molecule inhibitor of the phenylalanine (Phe) transporter SLC6A19 and is in development as a potential first-in-class oral treatment for PKU.

Key Points: 
  • JNT-517 is a small molecule inhibitor of the phenylalanine (Phe) transporter SLC6A19 and is in development as a potential first-in-class oral treatment for PKU.
  • "Dosing the first individual with PKU with JNT-517 is an important next step toward potentially improving the quality of life and health for people living with PKU,” said George Vratsanos, M.D., CMO and Head of R&D for Jnana Therapeutics.
  • “I’m thrilled to have joined Jnana at this critical point in the PKU program’s progression.”
    The Phase 1b study is a randomized, double-blind, placebo-controlled trial evaluating the safety, tolerability, pharmacokinetics, and effect on plasma and urinary Phe of JNT-517 over a four-week period in individuals with PKU.
  • The study expects to enroll 28 participants aged 18 to 65 diagnosed with PKU at clinical sites in the United States and Australia.