European Renal Association – European Dialysis and Transplant Association

Inversago Pharma Doses First Patient in Phase 2 Trial of INV-202, an Oral, Peripherally-acting CB1 Inverse Agonist, in Patients with Diabetic Kidney Disease

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Tuesday, November 29, 2022
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Inversago Pharma Inc. (Inversago), a clinical stage biotech company with a unique portfolio of peripherally-acting CB1 inverse agonists, today announced that the first patient has been dosed with INV-202 in a Phase 2 clinical trial in subjects with diabetic kidney disease (DKD).

Key Points: 
  • Inversago Pharma Inc. (Inversago), a clinical stage biotech company with a unique portfolio of peripherally-acting CB1 inverse agonists, today announced that the first patient has been dosed with INV-202 in a Phase 2 clinical trial in subjects with diabetic kidney disease (DKD).
  • Participants will receive once-daily oral doses of 10 or 25mg of INV-202 or placebo during the 16-week study.
  • This study builds on positive Phase 1b data that will be presented at a future scientific conference.
  • INV-202 is a small molecule CB1 inverse agonist being developed by Inversago for the potential treatment of a range of cardiometabolic and fibrotic conditions, including diabetic kidney disease.

Vera Therapeutics Provides Business Update and Reports Second Quarter 2022 Financial Results

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Wednesday, August 10, 2022
Lupus nephritis, U.S. Securities and Exchange Commission, BKV, Association, Autoantibody, ATC, Mortality, IgA nephropathy, Kidney disease, CEO, GLOBE, Standard of care, Private Securities Litigation Reform Act, B cell, Congress, Security (finance), Research, Immunoglobulin A, Patient, Virus, Therapy, COVID-19, Program, BK, Chronic kidney disease, B-cell activating factor, Polyomaviridae, Disease, Â, European Renal Association – European Dialysis and Transplant Association, BK virus, Vera, Nasdaq, Degenerative disease, Pharmaceutical industry, Cryptocurrency, Viremia

In the first half of 2022, we continued to successfully execute our development strategy and are on track to realize several significant milestones.

Key Points: 
  • In the first half of 2022, we continued to successfully execute our development strategy and are on track to realize several significant milestones.
  • Topline results from the study are expected to be presented early in the first quarter of 2023.
  • During the past quarter, we presented at multiple congresses highlighting our clinical data for each program.
  • Vera reported $131.9 million in cash, cash equivalents, and marketable securities as of June 30, 2022.

Aurinia Presents Data Demonstrating LUPKYNIS® (voclosporin) is Effective in Achieving Proteinuria Treatment Targets in Lupus Nephritis Defined by EULAR/ERA Recommendations

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Friday, June 3, 2022
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A treatment response meeting these proteinuria treatment targets increases the chance for better long-term kidney outcomes such as avoidance of kidney failure, dialysis or need for transplantation.

Key Points: 
  • A treatment response meeting these proteinuria treatment targets increases the chance for better long-term kidney outcomes such as avoidance of kidney failure, dialysis or need for transplantation.
  • LUPKYNIS is the first FDA-approved oral medicine for the treatment of adult patients with active lupus nephritis (LN).
  • In January 2021, the Company introduced LUPKYNIS (voclosporin), the first FDA-approved oral therapy for the treatment of adult patients with active lupus nephritis (LN).
  • QTc Prolongation: LUPKYNIS prolongs the QTc interval in a dose-dependent manner when dosed higher than the recommended lupus nephritis therapeutic dose.

Vera Therapeutics Announces New Atacicept Phase 2 Clinical Data in Two Oral Presentations at the 59th European Renal Association Congress

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Friday, May 20, 2022
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These data were included in two oral presentations at the European Renal Association - European Dialysis Transplant Association (ERA-EDTA) Congress being held May 19-22, 2022 in Paris, France, in person and virtually.

Key Points: 
  • These data were included in two oral presentations at the European Renal Association - European Dialysis Transplant Association (ERA-EDTA) Congress being held May 19-22, 2022 in Paris, France, in person and virtually.
  • Dr. Lin continued, We also presented new data from a post-hoc analysis from our double-blind, placebo-controlled Phase 2 study which suggested atacicept has the potential to improve renal function in patients with mild-to-moderate SLE renal disease.
  • We anticipate the planned Phase 3 COMPASS clinical trial evaluating atacicept 150 mg to help determine whether atacicept improves renal function in moderate-to-severe lupus nephritis.
  • Results from this post-hoc analysis of the Phase 2 trial of atacicept in SLE suggest atacicept may improve renal function in patients with mild-to-moderate SLE renal disease.

Inversago Pharma Presents Data on INV-202 in Diabetic Nephropathy at the ERA 2022 Congress

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Thursday, May 19, 2022
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These data show that INV-202, the companys lead peripheral CB1 blocker, reduced renal injury in a murine model of Streptozotocin (STZ)-induced Diabetes.

Key Points: 
  • These data show that INV-202, the companys lead peripheral CB1 blocker, reduced renal injury in a murine model of Streptozotocin (STZ)-induced Diabetes.
  • In particular, there was a marked, dose-dependent reduction in albuminuria in this model of diabetes and associated kidney injury.
  • The study showed that treatment with INV-202 reduced the progression of nephropathy in STZ-induced diabetic mice.
  • INV-202 is a small molecule CB1 inverse agonist / antagonist being developed by Inversago for the potential treatment of several metabolic conditions, including Diabetic Nephropathy.

Vera Therapeutics Provides Business Update and Reports First Quarter 2022 Financial Results

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Monday, May 16, 2022
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Topline results from the study are expected to be presented in the fourth quarter 2022, which we expect will be used to support the initiation of a pivotal Phase 3 clinical trial of atacicept in 2023.

Key Points: 
  • Topline results from the study are expected to be presented in the fourth quarter 2022, which we expect will be used to support the initiation of a pivotal Phase 3 clinical trial of atacicept in 2023.
  • Enrollment in the Phase 2b ORIGIN clinical trial of atacicept remains on track, topline data expected in the fourth quarter 2022.
  • Vera reported approximately $151 million in cash, cash equivalents and marketable securities as of March 31, 2022.
  • Vera Therapeutics is a late-stage biotechnology company focused on developing treatments for serious immunological diseases.

Unicycive Announces First Quarter Financial Results and Provides Business Update

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Thursday, May 12, 2022
Chronic kidney disease, CKD, Population, Company, Hyperphosphatemia, Stanford University School of Medicine, Research, Roth Capital Partners, Nasdaq, Patient, Poster, File, Nephrology, Insurance, Therapy, Liver, Clinical trial, Eye, MPH, Kidney, BE, FDA, IND, Kidney disease, Mitochondrial disease, AKI, Population health, Biotechnology, Conditional sentence, Heart, Acute kidney injury, NDA, European Renal Association – European Dialysis and Transplant Association, Mitochondrion, LOS, GLOBE, Pharmaceutical industry, Medicine

LOS ALTOS, Calif., May 12, 2022 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the first quarter ended March 31, 2022 and provided a business update.

Key Points: 
  • LOS ALTOS, Calif., May 12, 2022 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc.(Nasdaq: UNCY), a clinical stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the first quarter ended March 31, 2022 and provided a business update.
  • Throughout the first quarter, we continued to make meaningful progress to advance and expand the clinical development of our lead product candidates.
  • Unicycive plans to enroll the first subject in a bioequivalence (BE) study in healthy volunteers to demonstrate the comparability of Renazorb to the reference listed drug, Fosrenol, in the second quarter.
  • General and administrative expenses for the quarter ended March 31, 2022 were $1.6 million, compared to $0.3 million for the same quarter in 2021.

Poxel Announces Its Participation in Upcoming Scientific Conferences

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Monday, April 25, 2022
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POXEL SA (Euronext: POXEL - FR0012432516), a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including non-alcoholic steatohepatitis (NASH) and rare metabolic disorders, today announces that the Poxel team will participate in several upcoming scientific conferences in May 2022.

Key Points: 
  • POXEL SA (Euronext: POXEL - FR0012432516), a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including non-alcoholic steatohepatitis (NASH) and rare metabolic disorders, today announces that the Poxel team will participate in several upcoming scientific conferences in May 2022.
  • Poxel is a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including non-alcoholic steatohepatitis (NASH) and rare disorders.
  • Poxel has clinical and earlier-stage programs from its adenosine monophosphate-activated protein kinase (AMPK) activator and deuterated TZD platforms targeting chronic and rare metabolic diseases.
  • Listed on Euronext Paris, Poxel is headquartered in Lyon, France, and has subsidiaries in Boston, MA, and Tokyo, Japan.

Unicycive Announces Full Year 2021 Financial Results and Provides Business Update

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Thursday, March 31, 2022
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LOS ALTOS, Calif., March 31, 2022 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the full year ended December 31, 2021 and provided a business update.

Key Points: 
  • LOS ALTOS, Calif., March 31, 2022 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc.(Nasdaq: UNCY), a clinical stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the full year ended December 31, 2021 and provided a business update.
  • The primary endpoint of the study is LS mean change in urinary phosphate excretion from baseline to the evaluation period.
  • The Unicycive team is preparing to capitalize on this substantial opportunity by offering patients and providers an attractive treatment alternative.
  • Unicycive is conducting important market research to inform its brand and market access strategy and comprehensive launch plan for Renazorb.

Chinook Therapeutics Presents Data from BION-1301 Phase 1/2 Trial in Patients with IgA Nephropathy (IgAN) and Atrasentan Program at the American Society of Nephrology (ASN) Kidney Week 2021

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Thursday, November 4, 2021
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Blocking APRIL is a potentially disease-modifying approach to treating IgAN by reducing circulating levels of galactose-deficient IgA1 (Gd-IgA1).

Key Points: 
  • Blocking APRIL is a potentially disease-modifying approach to treating IgAN by reducing circulating levels of galactose-deficient IgA1 (Gd-IgA1).
  • Patients in Cohort 1 received an intravenous (IV) dose of 450 mg of BION-1301 every two weeks.
  • Chinooks lead program is atrasentan, a phase 3 endothelin receptor antagonist for the treatment of IgA nephropathy and other proteinuric glomerular diseases.
  • BION-1301, an anti-APRIL monoclonal antibody is being evaluated in a phase 1/2 trial for IgA nephropathy.