T2DM

HighTide Therapeutics Announces First Patient Dosed in Phase 2b Clinical Study Evaluating HTD1801 in NASH (the CENTRICITY study)

Retrieved on: 
Wednesday, January 11, 2023

ROCKVILLE, MD and SHENZHEN, CHINA, Jan 11, 2023 - (ACN Newswire) - HighTide Therapeutics Inc. ("HighTide"), a globally integrated clinical-stage biopharmaceutical company developing novel multifunctional therapies for metabolic and digestive diseases, today announced the dosing of the first patient in a Phase 2b clinical study evaluating HTD1801 for the treatment of nonalcoholic steatohepatitis ("NASH").

Key Points: 
  • ROCKVILLE, MD and SHENZHEN, CHINA, Jan 11, 2023 - (ACN Newswire) - HighTide Therapeutics Inc. ("HighTide"), a globally integrated clinical-stage biopharmaceutical company developing novel multifunctional therapies for metabolic and digestive diseases, today announced the dosing of the first patient in a Phase 2b clinical study evaluating HTD1801 for the treatment of nonalcoholic steatohepatitis ("NASH").
  • This double-blind, randomized, placebo-controlled, multicentre Phase 2b study will evaluate the effect of HTD1801, 1250 mg twice daily (BID), compared to placebo BID on histologic improvement in adult subjects with NASH and liver fibrosis who also have type 2 diabetes mellitus ("T2DM") or pre-diabetes.
  • The study will enroll approximately 210 subjects with biopsy-confirmed NASH and evidence of stage 2 or stage 3 liver fibrosis.
  • "Nonalcoholic fatty liver disease ("NAFLD") is the most prevalent chronic liver disease worldwide with a global prevalence of 25.2% to 29.8%.

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.”

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."

Alnylam Submits CTA Application for ALN-KHK, an Investigational RNAi Therapeutic for the Treatment of Type 2 Diabetes

Retrieved on: 
Wednesday, December 21, 2022

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi (RNA interference) therapeutics company, announced today that the Company has submitted a Clinical Trial Authorization (CTA) application to Health Canada to initiate a Phase 1/2 study of ALN-KHK, an investigational RNAi therapeutic targeting ketohexokinase (KHK) for the treatment of Type 2 diabetes mellitus (T2DM).

Key Points: 
  • Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi (RNA interference) therapeutics company, announced today that the Company has submitted a Clinical Trial Authorization (CTA) application to Health Canada to initiate a Phase 1/2 study of ALN-KHK, an investigational RNAi therapeutic targeting ketohexokinase (KHK) for the treatment of Type 2 diabetes mellitus (T2DM).
  • “We are excited to advance ALN-KHK to the clinic as our first RNAi therapeutic to address the unmet medical need in Type 2 diabetes mellitus and potentially other metabolic disorders,” said Neil Wallace, Program Leader for the ALN-KHK program at Alnylam.
  • “Increased dietary fructose consumption, largely resulting from use of high-fructose corn syrup as a sweetener, is believed to contribute to the growing pandemic of obesity.
  • Fructose itself predisposes to fatty liver disease and thus, in the context of T2DM, aggravates insulin resistance.

MindRank Announces U.S. FDA Clearance of IND Application for MDR-001, a Novel GLP-1 Receptor Agonist for the Treatment of Type 2 Diabetes and Obesity

Retrieved on: 
Monday, December 26, 2022

MindRank expects to initiate a Phase I safety study in the first quarter of 2023.

Key Points: 
  • MindRank expects to initiate a Phase I safety study in the first quarter of 2023.
  • Empowered by Mindrank's proprietary AI drug discovery platform, Molecule Pro™, it just took the company 19 months to obtain the IND approval since the MDR-001 program was initiated.
  • "By facilitating novel small molecule drug design with desired drug-like properties, we believe our AI platform can significantly improve the pre-clinical R&D efficiency.
  • The FDA IND approval of MDR-001 is a solid validation for the potential of our AI platform."

MindRank Announces U.S. FDA Clearance of IND Application for MDR-001, a Novel GLP-1 Receptor Agonist for the Treatment of Type 2 Diabetes and Obesity

Retrieved on: 
Monday, December 26, 2022

MindRank expects to initiate a Phase I safety study in the first quarter of 2023.

Key Points: 
  • MindRank expects to initiate a Phase I safety study in the first quarter of 2023.
  • Empowered by Mindrank's proprietary AI drug discovery platform, Molecule Pro™, it just took the company 19 months to obtain the IND approval since the MDR-001 program was initiated.
  • "By facilitating novel small molecule drug design with desired drug-like properties, we believe our AI platform can significantly improve the pre-clinical R&D efficiency.
  • The FDA IND approval of MDR-001 is a solid validation for the potential of our AI platform."

Oramed Announces Publication of Oral Insulin Study in Peer-Reviewed Journal: Diabetes, Obesity, and Metabolism

Retrieved on: 
Tuesday, November 29, 2022

The trial met the primary endpoint of statistically significant reductions of HbA1c from baseline to Week 12.

Key Points: 
  • The trial met the primary endpoint of statistically significant reductions of HbA1c from baseline to Week 12.
  • "This paper presents interesting and important results of Oramed's Phase 2 dose ranging study of oral insulin.
  • Oramed Pharmaceuticals (Nasdaq: ORMP) (TASE: ORMP) is a platform technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection.
  • Established in 2006, with offices in the United States and Israel, Oramed has developed a novel Protein Oral Delivery (POD) technology.

American Journal of Gastroenterology Publishes Data from HighTide Therapeutics' Phase 2 Study of HTD1801 Treatment in Primary Sclerosing Cholangitis

Retrieved on: 
Wednesday, November 16, 2022

This study met the primary endpoint and multiple key secondary endpoints, demonstrating the safety and efficacy of HTD1801 in treating PSC.

Key Points: 
  • This study met the primary endpoint and multiple key secondary endpoints, demonstrating the safety and efficacy of HTD1801 in treating PSC.
  • Data show that compared to placebo, both low and high doses of HTD1801 treatment could significantly reduce serum ALP levels.
  • In addition, HTD1801 significantly reduced alanine aminotransferase (ALT), aspartate aminotransferase (AST), and gamma-glutamyl transferase (GGT), further supporting the beneficial effects of HTD1801 in treating PSC.
  • The improvements in ALP we observed in this study, along with the excellent safety profile of HTD1801, are promising.

ReShape Lifesciences™ Presents Data on Proprietary Diabetes Bloc-Stim Neuromodulation™ Device at ObesityWeek®

Retrieved on: 
Thursday, November 3, 2022

Despite medication, surgery and diet, type 2 diabetes remains challenging to effectively treat, stated Jonathan Waataja, Director of Research at ReShape Lifesciences.

Key Points: 
  • Despite medication, surgery and diet, type 2 diabetes remains challenging to effectively treat, stated Jonathan Waataja, Director of Research at ReShape Lifesciences.
  • Previously, the area under the curve of oral glucose tolerance tests (OGTTs) was calculated to quantify glycemic control.
  • The opportunity to present such compelling data on our proprietary DBSN device at this industry conference is a testament to the market potential of the technology to treat type 2 diabetes, stated Paul F. Hickey, President and Chief Executive Officer of ReShape Lifesciences.
  • The investigational Diabetes Bloc-Stim Neuromodulation (DBSN) system utilizes a proprietary vagus nerve block and stimulation technology platform for the treatment of Type 2 diabetes and metabolic disorders.

Eccogene Announces US IND Approval for GLP-1 Receptor Agonist ECC5004

Retrieved on: 
Thursday, November 3, 2022

This study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ECC5004 in healthy participants and subjects with T2DM.

Key Points: 
  • This study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ECC5004 in healthy participants and subjects with T2DM.
  • It also suppresses appetite to reduce body weight through activating GLP-1 receptors in certain areas of the brain.
  • "We are thrilled to share that FDA has cleared IND for our small molecule GLP-1 RA ECC5004.
  • This approval brings ECC5004, a well-designed small molecule GLP-1RA, closer to providing clinical benefits to hundreds of millions of patients affected by T2DM and obesity globally.