Hyperoxaluria

American Urological Association Announces 2024 Innovation Nexus Showcase Selections

Retrieved on: 
Wednesday, January 10, 2024
Nexus, Woman, Patient, Fertility, American Urological Association, Trauma, Therapy, Prostate cancer, Artificial intelligence, Bladder cancer, Urology, Showcase, Cystoscopy, Funding of science, FACS, University, Surgery, Incontinence, Carboxypeptidase, Hyperoxaluria, Conference, Urinary tract infection, Information technology, Urethra, Patient safety, AUA, Medical imaging

Baltimore, Jan. 10, 2024 (GLOBE NEWSWIRE) -- The American Urological Association (AUA) is pleased to announce the ten companies chosen through a rigorous and highly competitive selection process for the second annual Innovation Nexus Showcase.

Key Points: 
  • Baltimore, Jan. 10, 2024 (GLOBE NEWSWIRE) -- The American Urological Association (AUA) is pleased to announce the ten companies chosen through a rigorous and highly competitive selection process for the second annual Innovation Nexus Showcase.
  • Innovation Nexus is a long-term commitment by the AUA to sustain a urology incubator to advance discoveries with key stakeholders to benefit urologic patient care.
  • As part of the multi-faceted program, the AUA will host an annual Innovation Nexus Conference, with the second event being held on May 2 in San Antonio, TX, before the AUA Annual Meeting.
  • For more information on the Showcase and to register to attend the May 2 event, please visit: https://auanexus.org/

Omeros Corporation Hires Andreas Grauer M.D. as Chief Medical Officer

Retrieved on: 
Thursday, October 19, 2023
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, Hyperoxaluria, Heidelberg University School of Medicine, Proctor, Endocrinology, Nephrology, Publication, Inflammation, Metabolism, Corcept Therapeutics, Baylor College of Medicine, Medicine, Amgen, Internal medicine, Neurology, Corporation, University, NDA, Safety, Therapy, Patient, BLA, Baylor University, Pharmaceutical industry, Management, Omeros

Omeros Corporation (Nasdaq: OMER) today announced that Andreas Grauer, M.D., has been named Omeros’ chief medical officer.

Key Points: 
  • Omeros Corporation (Nasdaq: OMER) today announced that Andreas Grauer, M.D., has been named Omeros’ chief medical officer.
  • In his new role, Dr. Grauer will be responsible for guiding all clinical activities globally for the company, including clinical development and operations, medical affairs, safety, and biometrics.
  • “We are very pleased to welcome Andreas to Omeros’ leadership team,” said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros.
  • He joins Omeros from Federation Bio where, as chief medical officer, he led all clinical activities with a focus on hyperoxaluria and immuno-oncology.

Novome Biotechnologies Raises $43.5 Million Series B Financing to Advance its Pipeline of Therapeutically Engineered Microbes

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Tuesday, September 13, 2022
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SOUTH SAN FRANCISCO, Calif., Sept. 13, 2022 (GLOBE NEWSWIRE) -- Novome Biotechnologies, Inc., a biotechnology company engineering first-in-class, living medicines for chronic diseases, today announced the close of a $43.5 million Series B financing. The financing was led by Tencent, and includes new investors University of Minnesota, Navian Investments, Colorcon Ventures and Touchdown Ventures. Existing investors DCVC Bio, 5AM Ventures, Alta Partners and Alexandria Venture Investments also participated in the financing.

Key Points: 
  • The financing was led by Tencent, and includes new investors University of Minnesota, Navian Investments, Colorcon Ventures and Touchdown Ventures.
  • "Novome's recent accomplishments and this new funding should further advance and validate our platform's capabilities and unlock additional pipeline opportunities.
  • I am grateful for the strong support of new and current investors who share our vision of developing first-in-class therapeutically engineered gut microbes.
  • Novome Biotechnologies is a clinical-stage biotechnology company developing engineered cellular therapies for the gut to treat chronic diseases.

BridgeBio Pharma Announces Positive Phase 1 Data and Phase 2/3 Trial Design for BBP-711, a Potentially Best-In-Class GO Inhibitor for Primary Hyperoxaluria Type 1 (PH1) and Recurrent Kidney Stone Formers

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Monday, June 27, 2022
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PALO ALTO, Calif., June 27, 2022 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced positive Phase 1 data for BBP-711 in healthy volunteers, supporting the development of the investigational therapy for patients with primary hyperoxaluria type 1 (PH1) and recurrent kidney stone formers. The data were shared in a feature oral presentation at European Society for Pediatric Nephrology (ESPN) 2022, taking place in Ljubljana, Slovenia.

Key Points: 
  • BBP-711 is an orally-administered small molecule inhibitor of glycolate oxidase (GO) that is being developed to treat conditions of excess oxalate.
  • Overproduction of oxalate in hyperoxaluria, including PH1 and recurrent kidney stone formers with elevated oxalate, can lead to kidney stone formation, nephrocalcinosis and renal impairment.
  • These data are encouraging for patients with PH1 as BBP-711 could become a novel oral therapy to prevent hyperoxaluria and its long-term consequences.
  • Moreover, BridgeBio operates in a very competitive and rapidly changing environment in which new risks emerge from time to time.

Novome Biotechnologies Reports Positive Results from a Phase 1 Study of NOV-001

Retrieved on: 
Wednesday, November 17, 2021
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SOUTH SAN FRANCISCO, Calif., Nov. 17, 2021 (GLOBE NEWSWIRE) -- Novome Biotechnologies, Inc., a clinical-stage biotechnology company developing engineered cellular therapies for the gut, today announced positive results from a Phase 1 study of orally-administered NOV-001 in healthy volunteers. The Phase 1 study demonstrated the ability to safely colonize the human gut with a therapeutically engineered microbe and control its abundance via once-daily dosing of a prebiotic control molecule. Based on these results, Novome intends to commence a Phase 2a study to evaluate preliminary efficacy in patients with enteric hyperoxaluria.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., Nov. 17, 2021 (GLOBE NEWSWIRE) -- Novome Biotechnologies, Inc., a clinical-stage biotechnology company developing engineered cellular therapies for the gut, today announced positive results from a Phase 1 study of orally-administered NOV-001 in healthy volunteers.
  • Based on these results, Novome intends to commence a Phase 2a study to evaluate preliminary efficacy in patients with enteric hyperoxaluria.
  • This groundbreaking study validates Novomes approach to controllably and safely engraft a therapeutically engineered microbe into the human gut.
  • In the Phase 1 study, the dose of NB2000P was modified within adaptive groups to tune the abundance of NB1000S in the gut.

Alnylam Presents Positive Results from ILLUMINATE-C Phase 3 Study of Lumasiran in Patients with Advanced Primary Hyperoxaluria Type 1

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Friday, November 5, 2021
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PH1 patients progressing to or being diagnosed with end-stage kidney disease often have substantial elevations in plasma oxalate despite intensive hemodialysis.

Key Points: 
  • PH1 patients progressing to or being diagnosed with end-stage kidney disease often have substantial elevations in plasma oxalate despite intensive hemodialysis.
  • ILLUMINATE-C enrolled 21 patients: six patients in Cohort A who did not require dialysis and 15 patients on hemodialysis in Cohort B.
  • OXLUMO is indicated for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients.
  • Lumasiran is a subcutaneously administered RNAi therapeutic targeting hydroxyacid oxidase 1 (HAO1) in development for the treatment of primary hyperoxaluria type 1 (PH1).

Synlogic Presents Data on Hyperoxaluria Program at American Society of Nephrology Kidney Week 2021

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Friday, October 15, 2021
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CAMBRIDGE, Mass., Oct. 15, 2021 /PRNewswire/ -- Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company bringing the transformative potential of synthetic biology to medicine, today announced two poster presentations at the upcoming American Society for Nephrology (ASN) Kidney Week 2021, to be held virtually November 4 7th, 2021.

Key Points: 
  • CAMBRIDGE, Mass., Oct. 15, 2021 /PRNewswire/ -- Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company bringing the transformative potential of synthetic biology to medicine, today announced two poster presentations at the upcoming American Society for Nephrology (ASN) Kidney Week 2021, to be held virtually November 4 7th, 2021.
  • At this dose, the percent reduction from baseline UOx levels was -28.6% (90% CI: -42.4 to -11.6) compared to placebo in diet-induced hyperoxaluria.
  • Enteric Hyperoxaluria results in dangerously high levels of urinary oxalate, which causes progressive kidney damage, kidney stone formation, and nephrocalcinosis.
  • However, while Synlogic may elect to update these forward-looking statements in the future, Synlogic specifically disclaims any obligation to do so.

Allena Pharmaceuticals to Participate in the 12th Annual Wedbush PacGrow Healthcare Conference

Retrieved on: 
Tuesday, August 3, 2021
Medical specialties, Kidney diseases, Organs anatomy), Clinical medicine, Hyperoxaluria, Hyperuricemia, Kidney stone disease, Oxalate, Kidney, Uric acid, Chronic kidney disease

Management will also be available for 1x1 meetings onTuesday, August 10th Wednesday, August 11th, 2021.

Key Points: 
  • Management will also be available for 1x1 meetings onTuesday, August 10th Wednesday, August 11th, 2021.
  • Allena Pharmaceuticals, Inc.is a biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class, oral biologic therapeutics to treat patients with rare and severe metabolic and kidney disorders.
  • Allenas lead product candidate, reloxaliase, is currently being evaluated in a pivotal Phase 3 clinical program for the treatment of enteric hyperoxaluria, a metabolic disorder characterized by markedly elevated urinary oxalate levels and commonly associated with kidney stones, chronic kidney disease and other serious kidney disorders.
  • Allena is also developing ALLN-346 for the treatment of hyperuricemia in the setting of gout and advanced chronic kidney disease, with a Phase 1 multiple-ascending dose study recently completed and a Phase 2a program planned for the second half of 2021.

Alnylam Reports Positive Topline Results from ILLUMINATE-C Phase 3 Study of Lumasiran in Patients with Advanced Primary Hyperoxaluria Type 1

Retrieved on: 
Thursday, July 29, 2021
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Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today positive topline results from the ILLUMINATE-C Phase 3 open-label study of lumasiran in patients of all ages with advanced primary hyperoxaluria type 1 (PH1) associated with progressive decline in renal function.

Key Points: 
  • Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today positive topline results from the ILLUMINATE-C Phase 3 open-label study of lumasiran in patients of all ages with advanced primary hyperoxaluria type 1 (PH1) associated with progressive decline in renal function.
  • Results of the primary analysis at six months demonstrated substantial reduction in plasma oxalate from baseline in patients (N=21) with advanced disease, including those on hemodialysis.
  • Cohort A enrolled six patients with advanced PH1 who do not yet require dialysis, and Cohort B enrolled 15 patients who are hemodialysis-dependent.
  • Lumasiran also demonstrated positive results across key secondary endpoints, including measures of urinary oxalate (for patients in Cohort A) and additional measures of plasma oxalate.

Allena Pharmaceuticals, Inc. to Present at the Ladenburg Thalmann 2021 Virtual Healthcare Conference

Retrieved on: 
Thursday, July 8, 2021
Kidney diseases, Medical specialties, Organs anatomy), Clinical medicine, Hyperoxaluria, Hyperuricemia, Kidney stone disease, Oxalate, Chronic kidney disease, Kidney disease, Kidney, Uric acid

Allena Pharmaceuticals, Inc.is a late-stage biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class, oral biologic therapeutics to treat patients with rare and severe metabolic and kidney disorders.

Key Points: 
  • Allena Pharmaceuticals, Inc.is a late-stage biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class, oral biologic therapeutics to treat patients with rare and severe metabolic and kidney disorders.
  • Allenas lead product candidate, reloxaliase, is currently being evaluated in a pivotal Phase 3 clinical program for the treatment of enteric hyperoxaluria, a metabolic disorder characterized by markedly elevated urinary oxalate levels and commonly associated with kidney stones, chronic kidney disease and other serious kidney disorders.
  • Allena is also developing ALLN-346 for the treatment of hyperuricemia in the setting of gout and advanced chronic kidney disease, with a Phase 1 multiple-ascending dose study currently in progress and a Phase 2a program planned for the second half of 2021.