Non-alcoholic fatty liver disease

D&D Pharmatech Announces Rapid, Clinically Significant Reductions in Liver Fat Achieved in Four Weeks Treating NAFLD Patients with DD01, a Novel Long-Acting GLP-1/Glucagon Receptor Agonist

Retrieved on: 
Tuesday, May 2, 2023

Following only four (4) weeks of once-weekly treatment, up to 100% of patients achieved >30% liver fat reduction by MRI-PDFF.

Key Points: 
  • Following only four (4) weeks of once-weekly treatment, up to 100% of patients achieved >30% liver fat reduction by MRI-PDFF.
  • A ≥30% reduction in liver fat is associated with a clinically significant improvement in NASH scores.
  • DD01 treatment results in rapid and clinically significant reductions in liver fat in only 4 weeks of treatment.
  • Patients may achieve rapid reductions in liver fat while benefiting over the long term from improved glycemic control and weight loss.

PATIENT GROUPS DECLARE ICER REVIEW OF NASH MEDICATIONS CAUSES MORE UNCERTAINTY AND CONTROVERSIES THAN IT RESOLVES

Retrieved on: 
Friday, April 28, 2023

NAFLD is a chronic progressive condition of which NASH is the more advanced form, where the extra fat turns into inflammation (swelling) and fibrosis (scarring) of the liver.

Key Points: 
  • NAFLD is a chronic progressive condition of which NASH is the more advanced form, where the extra fat turns into inflammation (swelling) and fibrosis (scarring) of the liver.
  • If severe enough, NASH can lead to cirrhosis, cancer, the need for a transplant, or death.
  • Donna Cryer, President & CEO of Global Liver Institute and 28-year liver transplant survivor said, “NASH is a chronic, progressive illness.
  • GLI calls on ICER to take these patient experiences seriously in its evaluation in the final assessment of resmetirom and obeticholic acid for the treatment of NASH.

Better Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Updates

Retrieved on: 
Thursday, March 30, 2023

Publication of BT-001 Pivotal Clinical Trial Results: In October 2022, results from Better Therapeutics’ pivotal clinical trial of BT-001 in adult patients with T2D were published in the American Diabetes Association-produced, peer-reviewed journal Diabetes Care.

Key Points: 
  • Publication of BT-001 Pivotal Clinical Trial Results: In October 2022, results from Better Therapeutics’ pivotal clinical trial of BT-001 in adult patients with T2D were published in the American Diabetes Association-produced, peer-reviewed journal Diabetes Care.
  • Company Announces Restructuring To Preserve Cash Runway: In March 2023, Better Therapeutics announced it would implement a reduction in force impacting 35% of the workforce.
  • Better Therapeutics periodically provides other information for investors on its corporate website, http://www.bettertx.com , and its investor relations website, https://investors.bettertx.com .
  • Accordingly, investors should monitor Better Therapeutics’ website, in addition to following its press releases, SEC filings, and public conference calls and webcasts.

Validation of a Pragmatic Clinical Risk-Based Classification of NASH - New Supporting Real World Evidence from TARGET-NASH

Retrieved on: 
Thursday, March 30, 2023

"Validation of a Clinical Risk-Based Classification System in a Large Nonalcoholic Fatty Liver Disease Real-world Cohort," was published in the peer-reviewed publication Clinical Gastroenterology and Hepatology .

Key Points: 
  • "Validation of a Clinical Risk-Based Classification System in a Large Nonalcoholic Fatty Liver Disease Real-world Cohort," was published in the peer-reviewed publication Clinical Gastroenterology and Hepatology .
  • More than 20% of the US population is affected by NAFLD, which represents a major and growing public health concern with significant health economic implications.
  • While there are no approved curative therapies to date, there are multiple new therapies currently under review with the FDA.
  • Identifying patient populations in the real world who will need these upcoming treatments will be critical when these novel treatments become available.

Tempo Bioscience Expands Human Liver Models for Toxicity Evaluation and Disease Modeling

Retrieved on: 
Wednesday, March 15, 2023

Together, Tempo-iHepStellate™-iKupffer™-iLSEC™-iHep3D™ form human liver organoids for modeling diseases such as Nonalcoholic Steatohepatitis (NASH), Nonalcoholic fatty liver disease (NAFLD), liver fibrosis, cirrhosis, and hepatocellular carcinoma (HCC).

Key Points: 
  • Together, Tempo-iHepStellate™-iKupffer™-iLSEC™-iHep3D™ form human liver organoids for modeling diseases such as Nonalcoholic Steatohepatitis (NASH), Nonalcoholic fatty liver disease (NAFLD), liver fibrosis, cirrhosis, and hepatocellular carcinoma (HCC).
  • Derivative cell types from human iPSCs offer purity of genetic materials, human relevance, and robust patient matched models.
  • Tempo Bioscience is the sole manufacturer of human iPSC-derived cell types that are engineered using non-viral, nucleic-acids-free, serum-free, and feeder-free technologies.
  • Tempo is committed to advancing technologies that focus on disease modeling and drug safety evaluations using advanced human iPSC-derived cell models in 2D, as well as in 3D as spheroids or organoids.

ENDRA Life Sciences Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Update

Retrieved on: 
Tuesday, March 14, 2023

ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), today reported financial results for the three months and year ended December 31, 2022, and provided a business update.

Key Points: 
  • ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), today reported financial results for the three months and year ended December 31, 2022, and provided a business update.
  • Highlights include:
    Over 100 TAEUS system scans performed at global clinical evaluation sites in 2022 and deployed a new interactive guidance tool.
  • In 2022, the ENDRA team met with prospective customers and key partners at 11 clinical conferences in the U.S. and Europe.
  • In 2022, 19 patents were issued to ENDRA, including two U.S. patents announced in the fourth quarter.

Aligos Therapeutics Reports Recent Business Progress and Fourth Quarter and Full Year 2022 Financial Results

Retrieved on: 
Thursday, March 9, 2023

SOUTH SAN FRANCISCO, Calif., March 09, 2023 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, today reported recent business progress and financial results for the fourth quarter and full year 2022.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., March 09, 2023 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, today reported recent business progress and financial results for the fourth quarter and full year 2022.
  • "Last year was very productive for our team,” said Lawrence Blatt, PhD, MBA, Chairman & CEO of Aligos.
  • Taken together, we expect these programs to have multiple important data readouts as we continue to advance them throughout 2023.
  • General and administrative (G&A) expenses for the year ended December 31, 2022, were $26.4 million compared with $28.5 million for the same period of 2021.

MRM Health Completes Patient Recruitment in Ulcerative Colitis Study, Secures Financing and Provides Outlook for 2023

Retrieved on: 
Tuesday, March 7, 2023

“2023 also started very promising as we reached a major milestone by completing early January patient recruitment in the Phase 2a study with MH002 in Ulcerative Colitis, while patient recruitment in our phase 2 study in Acute Pouchitis continues to progress.

Key Points: 
  • “2023 also started very promising as we reached a major milestone by completing early January patient recruitment in the Phase 2a study with MH002 in Ulcerative Colitis, while patient recruitment in our phase 2 study in Acute Pouchitis continues to progress.
  • MRM Health has now enrolled all 45 mild-to-moderate UC patients.
  • MRM Health has an ongoing corporate partnership with IFF since 2020, aiming to tackle a range of metabolic diseases.
  • As part of its ongoing program in T2D, MRM Health recently reached a next milestone upon successfully achieving preclinical development targets.

Lumos Pharma Reports Full Year 2022 Financial Results, Provides Clinical Development Updates

Retrieved on: 
Wednesday, March 1, 2023

AUSTIN, Texas, March 01, 2023 (GLOBE NEWSWIRE) -- Lumos Pharma, Inc. (NASDAQ:LUMO), a clinical-stage biopharmaceutical company focused on therapeutics for rare diseases, today announced financial results for the year ended December 31, 2022.

Key Points: 
  • AUSTIN, Texas, March 01, 2023 (GLOBE NEWSWIRE) -- Lumos Pharma, Inc. (NASDAQ:LUMO), a clinical-stage biopharmaceutical company focused on therapeutics for rare diseases, today announced financial results for the year ended December 31, 2022.
  • Data from the interim analysis of our OraGrowtH210 Trial showed LUM-201 met growth expectations, showed durable response and was well-tolerated.
  • Financial Results for the Year Ended December 31, 2022
    Cash Position – Lumos Pharma ended the year on December 31, 2022, with cash, cash equivalents, and short-term investments totaling $67.4 million compared to $94.8 million on December 31, 2021.
  • Lumos Pharma ended Q4 2022 with 8,267,968 shares outstanding.

Altimmune Announces Fourth Quarter and Full Year 2022 Financial Results and Provides a Business Update

Retrieved on: 
Tuesday, February 28, 2023

GAITHERSBURG, Md., Feb. 28, 2023 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced financial results for the fourth quarter and full year ended December 31, 2022, and provided a business update.

Key Points: 
  • Webcast to be held today, February 28, 2023, at 8:30 am ET
    GAITHERSBURG, Md., Feb. 28, 2023 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced financial results for the fourth quarter and full year ended December 31, 2022, and provided a business update.
  • We expect the key endpoints of this trial to be NASH resolution and fibrosis improvement, both assessed following 24 weeks of treatment.
  • Financial Results for the Three Months Ended December 31, 2022
    Altimmune had cash, cash equivalents and short-term investments totaling $184.9 million at December 31, 2022.
  • General and administrative expenses were consistent period-over-period at $3.8 million for each of the three months ended December 31, 2022 and 2021.