Alcoholic hepatitis

ZyVersa Therapeutics Announces a Publication in Hepatology Revealing That Alcohol-induced Extracellular ASC Specks Perpetuate Liver Inflammation and Damage in Alcoholic Hepatitis

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Thursday, May 4, 2023
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Reported data demonstrate a central role of NLRP3 and ASC in alcohol-induced liver inflammation, and highlight the critical role of extracellular ASC specks in the propagation of systemic and liver inflammation in AH

Key Points: 
  • Reported data demonstrate a central role of NLRP3 and ASC in alcohol-induced liver inflammation, and highlight the critical role of extracellular ASC specks in the propagation of systemic and liver inflammation in AH
    WESTON, Fla., May 04, 2023 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of inflammatory and renal diseases, announces publication of an article in the peer-reviewed journal, Hepatology, supporting the critical role of extracellular ASC specks in propagating damaging liver inflammation in AH.
  • In the paper titled, “Alcohol-induced extracellular asc specks perpetuate liver inflammation and damage in alcoholic hepatitis even after alcohol cessation,” the authors reported that alcohol consumption induces NLRP3 inflammasome activation in the liver, and alcohol binges additionally increase circulating extracellular ASC specks and hepatic ASC aggregates leading to perpetuation of damaging inflammation.
  • Given the lack of specific treatment for AH, our data support NLRP3 as a therapeutic target in AH.” To read the article, Click Here .
  • “The research published in Hepatology demonstrating that alcohol-induced extracellular ASC specks perpetuate liver inflammation and damage provides support for targeting inflammasome ASC with IC 100, which has been shown to disrupt the structure and function of both intra- and extracellular ASC specks,” commented Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO and President.

Arrowhead Pharmaceuticals Announces $30 Million Milestone Payment from GSK

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Monday, April 3, 2023
Research, General Health, Pharmaceutical, Oncology, Infectious Diseases, Genetics, Clinical Trials, Science, Cardiology, Biotechnology, FDA, Health, Arrowhead, GSK, NASH, Mutation, Dicarboxylic acid, Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., RNA, Hormone, Alcoholic hepatitis, Arrowhead Pharmaceuticals, Patient, Metabolism, HSD17B13, Fatty liver disease, RNA interference, Cirrhosis, Safety, Pharmaceutical industry, Greater China

Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced that it earned a $30 million milestone payment from GSK (LSE/NYSE: GSK) following the start of GSK’s Phase 2b trial of GSK4532990, formerly called ARO-HSD, an investigational RNA interference (RNAi) therapeutic for the treatment of patients with non-alcoholic steatohepatitis (NASH).

Key Points: 
  • Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced that it earned a $30 million milestone payment from GSK (LSE/NYSE: GSK) following the start of GSK’s Phase 2b trial of GSK4532990, formerly called ARO-HSD, an investigational RNA interference (RNAi) therapeutic for the treatment of patients with non-alcoholic steatohepatitis (NASH).
  • GSK4532990 is being developed under the November 2021 exclusive license agreement between Arrowhead and GSK.
  • GSK received an exclusive license to develop and commercialize GSK4532990 in all territories except Greater China, which was retained by Arrowhead.
  • GSK is wholly responsible for further clinical development and commercialization, outside of Greater China.

Surrozen Provides Fourth Quarter and Full Year 2022 Financial Results and Update on Clinical Pipeline and Corporate Progress

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Wednesday, March 22, 2023
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The company anticipates a reduction in operating expenses, excluding non-cash and non-recurring charges of approximately 15% in 2023 compared to 2022.

Key Points: 
  • The company anticipates a reduction in operating expenses, excluding non-cash and non-recurring charges of approximately 15% in 2023 compared to 2022.
  • Surrozen executed a partnership with Boehringer Ingelheim in the fourth quarter of 2022 to develop a Wnt agonist, SZN-413, for the treatment of people with retinal diseases.
  • In the fourth quarter of 2022, Surrozen entered into a securities purchase agreement with entities affiliated with Consonance Capital Management LP (collectively Consonance).
  • Surrozen will host an investor conference call and live audio webcast today at 4:30 PM ET to provide a corporate and pipeline update.

Seal Rock Therapeutics to Present at Biotech Showcase 2023

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Thursday, January 5, 2023
Parkinson's disease, ASK1, Partnership, Institute of Liver and Biliary Sciences, Therapy, McDonnell Aircraft Corporation, NASH, Seal Rock, Disease, Alcoholic hepatitis, Biotechnology, Pharmaceutical industry

SEATTLE, Jan. 5, 2023 /PRNewswire/ -- Seal Rock Therapeutics, Inc., a clinical stage company developing first-in-class and best-in-class kinase inhibitors, today announced that Neil McDonnell, Chief Executive Officer, will present at Biotech Showcase 2023, taking place January 9-11, 2023 in San Francisco.

Key Points: 
  • SEATTLE, Jan. 5, 2023 /PRNewswire/ -- Seal Rock Therapeutics, Inc., a clinical stage company developing first-in-class and best-in-class kinase inhibitors, today announced that Neil McDonnell, Chief Executive Officer, will present at Biotech Showcase 2023, taking place January 9-11, 2023 in San Francisco.
  • McDonnell will review clinical and preclinical data for the company's lead clinical candidate, SRT-015, a second-generation apoptosis signal-regulating kinase (ASK1) inhibitor for treatment of alcoholic hepatitis, NASH, and other liver diseases.
  • Presentation details are as follows:
    Location/Track: Hilton San Francisco Union Square, Franciscan C (Ballroom Level)
    Seal Rock will also be conducting one-on-one investor meetings at the Biotech Showcase from January 9 to 11, 2023.
  • Biotech Showcase, produced by Demy-Colton and EBD Group, is an investor conference focused on driving advances in therapeutic development by providing a sophisticated networking platform for executives and investors that fosters investment and partnership opportunities.

Aldeyra Therapeutics Submits New Drug Application to the U.S. Food and Drug Administration for Reproxalap for the Treatment of Signs and Symptoms of Dry Eye Disease

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Tuesday, November 29, 2022
Health, FDA, Other Health, Clinical Trials, Pharmaceutical, Optical, Biotechnology, Marketing, United, Risk, Therapy, Dry eye syndrome, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Duane syndrome, Security (finance), RASP, Chronic cough, Patient, Prevalence, Irritation, Pain, Dry, NDA, Allergic conjunctivitis, FDA, COVID-19, Growth, Result, Financial condition report, Lipid peroxidation, Food, Physician, Analysis, Toxicity, Annual report, Inflammation, Disease, Failure, Data analysis, Clinical trial, Safety, PMID, Tears, Conversation, Pharmacology, Biomarker, Asthma, Lubrication, Quality of life, Psoriasis, Alcoholic hepatitis, Eye, Pharmaceutical industry, Schirmer

Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for topical ocular reproxalap, an investigational new drug candidate, for the treatment of signs and symptoms of dry eye disease.

Key Points: 
  • Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for topical ocular reproxalap, an investigational new drug candidate, for the treatment of signs and symptoms of dry eye disease.
  • With data suggesting activity within minutes of administration, reproxalap could provide an important treatment option for the millions of dry eye patients who generally regard currently available therapies as inadequate.
  • Reproxalap is the lead product candidate in Aldeyras RASP modulator platform, which includes systemic disease pipeline candidates ADX-629 and related analogs.
  • In addition to dry eye disease, reproxalap is in late-stage development for allergic conjunctivitis, a condition that is commonly associated with dry eye disease.

Surrozen Reports Third Quarter 2022 Financial Results and Provides Corporate Update

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Monday, November 14, 2022
Observation, SAN, Colon, Retina, Tissue, Diabetic retinopathy, GGT, Research, Security (finance), Therapy, Collaboration, Inflammatory bowel disease, Eye, Regeneration, Insurance, Cochlea, Hepatitis, Patient, Expense, Ulcerative colitis, Development, Coronavirus, COVID-19, Growth, AST, Soft tissue injury, SAD, Lung, Partnership, Degenerative disease, Annual report, Homeostasis, Liver, Safety, Probability, Kidney, Administration, Hyperplasia, Hearing loss, Central nervous system, Boehringer Ingelheim, Alcoholic hepatitis, Disease, Institute of Liver and Biliary Sciences, Pharmaceutical industry, WNT

SOUTH SAN FRANCISCO, Calif., Nov. 14, 2022 (GLOBE NEWSWIRE) -- Surrozen, Inc. (Surrozen or the Company) (Nasdaq: SRZN), a company pioneering targeted therapeutics that selectively activate the Wnt pathway for tissue repair and regeneration, today reported financial results for the third quarter of 2022 and provided a corporate update.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., Nov. 14, 2022 (GLOBE NEWSWIRE) -- Surrozen, Inc. (Surrozen or the Company) (Nasdaq: SRZN), a company pioneering targeted therapeutics that selectively activate the Wnt pathway for tissue repair and regeneration, today reported financial results for the third quarter of 2022 and provided a corporate update.
  • Surrozen will be re-evaluating the overall clinical development timeline for this program and will provide an update at the appropriate time.
  • Financial Results for the Third Quarter Ended September 30, 2022
    Cash Position: Cash, cash equivalents and marketable securities for the third quarter ended September 30, 2022 were $78.4 million, compared to $92.7 million as of June 30, 2022.
  • However, while Surrozen may elect to update these forward-looking statements at some point in the future, Surrozen specifically disclaims any obligation to do so, except as required by law.

Unicycive Announces Third Quarter Financial Results and Provides Business Update

Retrieved on: 
Monday, November 14, 2022
Marketing, AKI, Acute kidney injury, Patent, BE, Medication, Safety, Enzyme, LOS, Partnership, Alcoholic hepatitis, Randomized controlled trial, NDA, MHRA, Research, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Dry, Hepatic encephalopathy, Hyperphosphatemia, FDA, United Kingdom, Nephrology, File, CTA, Degenerative disease, Therapy, Dialysis, Pharmacokinetics, IND, Nicorandil, Food, KATP, Liver disease, IgG4-related ophthalmic disease, Oxidative stress, Phosphate binder, Literature, Medicines and Healthcare products Regulatory Agency, New Drug Application, Medicine, Society, Chronic kidney disease, CKD, Kidney disease, Patient, Pharmaceutical industry, Generic drug, Glaucoma, SUR2B

LOS ALTOS, Calif., Nov. 14, 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 third quarter ended September 30, 2022, and provided a business update.

Key Points: 
  • The third quarter of 2022 and recent weeks have been particularly productive as we completed enrollment of our pivotal bioequivalence trial of RENAZORB, with topline results expected by year-end.
  • We remain on track to file a New Drug Application (NDA) in 2023, saidShalabh Gupta, M.D., Chief Executive Officer of Unicycive.
  • Dr. Gupta added, We were delighted to share favorable results from both our product candidates with the nephrology community at this years Kidney Week.
  • General and administrative expenses for the quarter ended September 30, 2022 were $1.7 million, compared with $0.9 million for the same quarter in 2021.

Seal Rock Therapeutics Announces Clinical and Preclinical Data on Differentiated ASK1 Inhibitor SRT-015 for Treatment of Alcoholic Hepatitis and Other Liver Diseases at The Liver Meeting® 2022

Retrieved on: 
Monday, November 7, 2022
ASK1, NASH, Non-alcoholic fatty liver disease, Therapy, Institute of Liver and Biliary Sciences, Plasma, AASLD, Seal Rock, Liver disease, Liver, Alcoholic hepatitis, Association, Patient, Drug discovery, American Association, Pharmaceutical industry

SEATTLE, Nov. 7, 2022 /PRNewswire/ -- Seal Rock Therapeutics, Inc., a clinical stage company developing first-in-class and best-in-class kinase inhibitors, today announced promising clinical and preclinical results for SRT-015, a second-generation apoptosis signal-regulating kinase (ASK1) inhibitor for treatment of alcoholic hepatitis and other liver diseases during an oral and poster presentation at The Liver Meeting® of the American Association for the Study of Liver Diseases (AASLD). The data demonstrate that SRT-015 is differentiated over first-generation ASK1 inhibitors and support future late-stage development of SRT-015.

Key Points: 
  • The data demonstrate that SRT-015 is differentiated over first-generation ASK1 inhibitors and support future late-stage development of SRT-015.
  • "Our presentations at The Liver Meeting support the promise of SRT-015 as a potential best-in-class second generation ASK1 inhibitor.
  • Our early clinical data are encouraging and support further advanced development efforts," said Neil McDonnell, Chief Executive Officer of Seal Rock Therapeutics.
  • SRT-015 is the next generation inhibitor of ASK1, developed internally by Seal Rock Therapeutics with the goal of overcoming liabilities that limited the clinical efficacy of selonsertib, the first ASK1 inhibitor to reach clinical development.

Surrozen Presents Data on Two Lead Therapeutic Candidates at United European Gastroenterology (UEG) Week

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Monday, October 10, 2022
Institute of Liver and Biliary Sciences, Lung, NOAEL, Disease, U.S. Securities and Exchange Commission, Therapy, Liver disease, Degenerative disease, Edu, Annual report, Liver injury, Retina, SCID, Hepatocyte, RATS, Hepatitis, Research, Tissue, Regeneration, Security (finance), Cell proliferation, Eye, Soft tissue injury, SC, Inflammation, Nasdaq, Coronavirus, United European Gastroenterology, Mouse, Probability, Trial of the century, Human, Cornea, Alcoholic hepatitis, CEO, Liver, Skin, GLOBE, Ulcerative colitis, Fibrosis, Forward-looking statement, Inflammatory bowel disease, Homeostasis, No-observed-adverse-effect level, GLP, Toxicology, COVID-19, Pancreas, Dietary supplement, Pharmaceutical industry, WNT

Phase 1 clinical trials of our SZN-1326 and SZN-043 programs were initiated in May and June, respectively, and are ongoing.

Key Points: 
  • Phase 1 clinical trials of our SZN-1326 and SZN-043 programs were initiated in May and June, respectively, and are ongoing.
  • Surrozen believes that the transient, self-limited hepatocyte proliferation induced by SZN-043, is likely controlled by negative feedback loops responsible for regulation of cell proliferation and liver homeostasis.
  • SZN-043-related changes were considered non-adverse, limited to clinical chemistry and changes in organ weight and demonstrated evidence of recovery in most cases.
  • Surrozen is a clinical-stage biotechnology company discovering and developing drug candidates to selectively modulate the Wnt pathway.

Unicycive Reports Key Findings of UNI-494 Efficacy in Preclinical Animal Model of Acute Kidney Injury (AKI)

Retrieved on: 
Wednesday, September 7, 2022
ADME, Literature, Enzyme, IgG4-related ophthalmic disease, Acute kidney injury, Vance DeGeneres, University, Kidney, Potassium, Safety, Hepatic encephalopathy, Research, Therapy, AKI, Chronic kidney disease, Randomized controlled trial, Hyperphosphatemia, Decision-making, Degenerative disease, Ischemia-reperfusion injury of the appendicular musculoskeletal system, MG, Macular degeneration, KATP, LOS, Kidney disease, RATS, Patent, Alcoholic hepatitis, Liver disease, Animal, GLOBE, Pharmacology, Urine, Nasdaq, Company, Biotechnology, ATP, Nicorandil, AMD, Ischemia, Oxidative stress, Patient, Pharmaceutical industry, Medicine, SUR2B

LOS ALTOS, Calif., Sept. 07, 2022 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical stage biotechnology company developing therapies for patients with kidney disease, today announced key findings of UNI-494 efficacy from a preclinical study in rodent model of Acute Kidney Injury.

Key Points: 
  • LOS ALTOS, Calif., Sept. 07, 2022 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc.(Nasdaq: UNCY), a clinical stage biotechnology company developing therapies for patients with kidney disease, today announced key findings of UNI-494 efficacy from a preclinical study in rodent model of Acute Kidney Injury.
  • The Company evaluated the effect of UNI-494 on ischemia-reperfusion induced acute kidney injury (IR-AKI) in rats.
  • We are excited to report this key finding from the IR-AKI model showing treatment with UNI-494 significantly reduced this key biomarker of kidney injury that is a well-accepted biomarker of proximal renal tubule damage.
  • UNI-494 is a patent-protected new chemical entity in late preclinical development for the treatment of acute kidney injury.For more information, please visit www.unicycive.com .