NASH

Presentation of Preclinical Study Highlighting Anti-Cancer Activity of Rencofilstat in Combination with Proteosome Inhibitors

Retrieved on: 
Tuesday, January 10, 2023

The presentation, entitled “A New Strategy to Increase Proteotoxic Stress in Prostate Cancer,” highlighted a preclinical study which investigated the killing of cultured prostate cancer cells by rencofilstat in combination with a proteasome inhibitor, ixazomib.

Key Points: 
  • The presentation, entitled “A New Strategy to Increase Proteotoxic Stress in Prostate Cancer,” highlighted a preclinical study which investigated the killing of cultured prostate cancer cells by rencofilstat in combination with a proteasome inhibitor, ixazomib.
  • Proteosome inhibitors are a class of anti-cancer agents that are used for the treatment of multiple myeloma and other blood cancers.
  • The present study showed that rencofilstat could synergistically increase the proteotoxic stress and in vitro cancer killing properties of ixazomib.
  • In this preclinical study, rencofilstat and ixazomib were applied at low concentrations to several types of prostate cancer cell lines, and also to non-cancerous prostate cells.

Akero Therapeutics Appoints Patrick Lamy as Senior Vice President, Commercial Strategy

Retrieved on: 
Tuesday, January 10, 2023

SOUTH SAN FRANCISCO, Calif., Jan. 10, 2023 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic disease marked by high unmet medical need, today announced the appointment of Patrick Lamy as Senior Vice President, Commercial Strategy.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., Jan. 10, 2023 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic disease marked by high unmet medical need, today announced the appointment of Patrick Lamy as Senior Vice President, Commercial Strategy.
  • “Akero is thrilled to welcome Patrick to the team, especially following last year’s HARMONY study results, which further demonstrate EFX’s potential to treat NASH holistically and reverse fibrosis rapidly,” said Andrew Cheng, M.D., Ph.D., president and chief executive officer of Akero.
  • Most recently he served as VP, Commercial at Iovance Biotherapeutics, where he was responsible for all pre-launch commercial activities for the first cell therapy for melanoma and cervical cancer.
  • “EFX has exhibited the potential to improve the lives of a great number of patients living with NASH,” said Patrick.

MediciNova Receives a Notice of Allowance for a New Patent Covering MN-001 and MN-002 for the Treatment of Hypertriglyceridemia, Hypercholesterolemia, and Hyperlipoproteinemia in Brazil

Retrieved on: 
Tuesday, January 10, 2023

Once issued, the patent maturing from this allowed patent application is expected to expire no earlier than July 2034.

Key Points: 
  • Once issued, the patent maturing from this allowed patent application is expected to expire no earlier than July 2034.
  • Ph.D., MPH., Chief Medical Officer, MediciNova, Inc., commented, “We are very pleased to receive notice that this new patent will be granted.
  • As we already have patents covering similar indications in the U.S., Canada, Europe, Japan, China, and Korea, we believe this additional patent in Brazil could increase the potential value of MN-001.
  • A trial to evaluate the efficacy and safety of MN-001 in patients with T2DM, NAFLD, and HTG is currently ongoing.”

Hepion Pharmaceuticals Receives $3.2 Million in Aggregate Non-Dilutive Funding

Retrieved on: 
Monday, January 9, 2023

NJEDA’s NOL program enables qualified, New Jersey-based technology or biotechnology companies to sell net operating losses to unrelated profitable corporations.

Key Points: 
  • NJEDA’s NOL program enables qualified, New Jersey-based technology or biotechnology companies to sell net operating losses to unrelated profitable corporations.
  • This allows qualifying technology and biotechnology companies with NOLs to turn their tax losses and credits into cash proceeds to fund growth and operations, including research and development (“R&D”) or other allowable expenditures.
  • Alberta’s Innovation Employment Grant program encourages economic growth by supporting small and medium-sized businesses that invest in R&D with a grant worth up to 20% of qualifying expenditures.
  • The program promotes investment and diversification by rewarding all R&D spending in Alberta, Canada, regardless of the industry.

NGM Bio Outlines Corporate Strategy and Provides Guidance on Key Priorities

Retrieved on: 
Monday, January 9, 2023

“In 2022, NGM Bio sharpened its focus on oncology solid-tumor clinical development.

Key Points: 
  • “In 2022, NGM Bio sharpened its focus on oncology solid-tumor clinical development.
  • Dr. Woodhouse continued, “Our strategy in 2023 is to focus our clinical development efforts on our portfolio of four clinical-stage oncology programs while operating our prolific drug discovery engine to generate next-generation biologic therapeutics.
  • For our programs outside this area of focus, in retinal disease and NASH, we will seek development partners with relevant domain expertise.
  • Presented additional findings from post-hoc analyses from the CATALINA trial at The Retina Society Annual Scientific Meeting in Q4 2022.

The Worldwide Non-Alcoholic Steatohepatitis Industry is Projected to Reach $15 Billion by 2027 - ResearchAndMarkets.com

Retrieved on: 
Monday, January 9, 2023

Elafibranor non-alcoholic steatohepatitis market is the fastest growing segment of global non-alcoholic steatohepatitis market in the forecasted period of 2023-2027 owing to positive impact of elafibranor in NASH treatment during clinical trials and drug's capability to reduce fat substance of liver, improving the conditions caused by NASH.

Key Points: 
  • Elafibranor non-alcoholic steatohepatitis market is the fastest growing segment of global non-alcoholic steatohepatitis market in the forecasted period of 2023-2027 owing to positive impact of elafibranor in NASH treatment during clinical trials and drug's capability to reduce fat substance of liver, improving the conditions caused by NASH.
  • By Application Type: The report provides the bifurcation of the market into two segments based on application type: treatment and diagnosis.
  • By Region: The report provides insight into the non-alcoholic steatohepatitis (NASH) market based on the regions namely North America, Europe, Asia Pacific, Middle East & Africa, and Latin America.
  • The Asia Pacific non-alcoholic steatohepatitis market is further divided into six regions on the basis of geographical operations, namely, China, India, Japan, Australia, South Korea and Rest of Asia Pacific, where China non-alcoholic steatohepatitis market held the largest share in Asia Pacific non-alcoholic steatohepatitis market.

Viking Therapeutics Announces Completion of Enrollment in Phase 2b VOYAGE Study of VK2809 in Patients with Biopsy-Confirmed Non-Alcoholic Steatohepatitis (NASH)

Retrieved on: 
Monday, January 9, 2023

SAN DIEGO, Jan. 9, 2023 /PRNewswire/ -- Viking Therapeutics, Inc. ("Viking") (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, today announced the completion of patient enrollment in its Phase 2b clinical trial of VK2809, the company's novel liver-selective thyroid hormone receptor beta agonist, in patients with biopsy-confirmed non-alcoholic steatohepatitis (NASH). The company expects to report data for the study's primary endpoint in the first half of 2023.

Key Points: 
  • The VOYAGE study is a randomized, double-blind, placebo-controlled, multicenter, international trial designed to assess the efficacy, safety and tolerability of VK2809 in patients with biopsy-confirmed NASH and fibrosis.
  • Enrollment included patients with at least 8% liver fat content as measured by magnetic resonance imaging proton density fat fraction, as well as F2 and F3 fibrosis.
  • The primary endpoint of the study will evaluate the change in liver fat content from baseline to Week 12 in patients treated with VK2809 as compared to patients receiving placebo.
  • The observed reductions in liver fat were durable, with the majority of patients remaining responders four weeks after completion of dosing.

HighTide Therapeutics Raises $107 Million in Series C/C+ Financing to Advance Innovative Pipeline and Business Collaborations

Retrieved on: 
Thursday, January 5, 2023

Proceeds of the financing will be used to advance multiple global development programs, including mid-to-late-stage clinical trials, and the commercialization and business development of the company's robust pipeline.

Key Points: 
  • Proceeds of the financing will be used to advance multiple global development programs, including mid-to-late-stage clinical trials, and the commercialization and business development of the company's robust pipeline.
  • "After completing a successful $60 million Series B+ round at the end of 2020, we are thrilled to have well-recognized investors participate in our C/C+ round.
  • "The Series C/C+ financing is a significant milestone for HighTide.
  • It will enable us to move aggressively to accelerate the clinical and commercial development of our innovative pipeline and external business collaborations."

Madrigal Announces Additional Positive Results from the Pivotal Phase 3 MAESTRO-NASH Clinical Trial of Resmetirom for the Treatment of NASH with Liver Fibrosis

Retrieved on: 
Friday, January 6, 2023

The new MAESTRO-NASH data are being presented at the NASH-TAG Conference, taking place from January 5-7, 2023 in Park City, Utah.

Key Points: 
  • The new MAESTRO-NASH data are being presented at the NASH-TAG Conference, taking place from January 5-7, 2023 in Park City, Utah.
  • An MRI-PDFF conducted during screening confirmed that patients had NAFLD prior to obtaining a liver biopsy.
  • Each pathologist's scores showed a similar statistically significant magnitude of response at both doses for both liver biopsy endpoints.
  • The consensus read by the two central pathologists reinforced the positive results observed in the primary analysis (Tables 1-2).

Hepion Pharmaceuticals to Present Phase 2a Rencofilstat Multiomics Data at NASH-TAG 2023

Retrieved on: 
Thursday, January 5, 2023

“Multiomics integration provides a wholistic view of drug-disease interaction,” said Patrick Mayo, PhD, Hepion’s Senior Vice President, Clinical Pharmacology & Analytics.

Key Points: 
  • “Multiomics integration provides a wholistic view of drug-disease interaction,” said Patrick Mayo, PhD, Hepion’s Senior Vice President, Clinical Pharmacology & Analytics.
  • “It has allowed Hepion to uncover a complete network of rencofilstat activity in NASH and other fibrotic diseases.
  • Critically, it allows us to determine responders versus non-responders, key genetic drivers, and biomarkers for NASH and other disease states.
  • We have learned that rencofilstat alters key drivers in the currently understood NASH pathway with augmented activity outside of currently proposed paradigms.