Drug Hunter’s Post

The burden of NAFLD (current terminology, MASLD) /NASH continues to increase over the years, with potentially lethal consequences on liver health. This article provides a comprehensive overview of NASH physiopathology, clinical trials that failed drugs but led to important insights and lessons learned, ongoing phase 2 and 3 clinical trials, and preliminary results where available.  In June 2023, Merck's GLP-1/glucagon receptor co-agonist won the FDA's Fast Track designation for NASH treatment. In September, the FDA gave Madrigal's drug, resmetiron, accelerated approval for patients with liver fibrosis and NASH, the most severe form of nonalcoholic fatty liver disease. Nathani RR, Bansal MB. Update on Clinical Trials for Nonalcoholic Steatohepatitis. Gastroenterol Hepatol (N Y). 2023 Jul;19(7):371-381. PMID: 37771619; PMCID: PMC10524415. https://lnkd.in/deBRDp76 #liverdisease #nash #clinicaltrials

💡MAESTRO-NASH Trial 💡 “Addressing the unmet need in the field of NASH treatment” MAESTRO-NASH, is a Phase 3 clinical trial that investigated the efficacy of resmetirom in treating nonalcoholic steatohepatitis (NASH) with liver fibrosis. The trial found that once-daily treatment with resmetirom for 52 weeks was superior to placebo in resolving NASH and improving fibrosis in patients with NASH and liver fibrosis. For a comprehensive understanding of the trial, I encourage you to check out the following resources: 📺 Watch the video: [https://lnkd.in/dAHkv_zY] 📖 Read the full article: [https://lnkd.in/dZSP7cQp] Based on the remarkable results of this trial, Resmetirom has received FDA approval on March 2024. 💡Here are some key points about this medication: ▪️Mechanism of Action: Resmetirom is a selective thyroid hormone receptor beta agonist. Resmetirom regulates metabolic pathways involved in lipid and glucose metabolism. This targeted activation is designed to reduce liver fat accumulation, decrease inflammation, and improve insulin sensitivity. ▪️Safety Profile: - The most common side effects are diarrhea and nausea. - Avoid in patients with decompensated cirrhosis, and if any signs or symptoms of worsening liver function occur during treatment, it should be discontinued. - Caution when combined with certain other drugs, particularly statins.

A biosimilar is a drug that’s highly similar to a biologic drug already authorized for sale. Biosimilars have been used safely for years. Health Canada has authorized biosimilar drugs for a range of conditions, including: • cancer • osteoporosis • Crohn’s disease • ulcerative colitis • rheumatoid arthritis Health Canada’s rigorous review standards mean that you can have the same trust in the quality, efficacy and safety of a biosimilar as in any other biologic drug. During #GlobalBiosimilarsWeek, we invite healthcare professionals to learn more about biosimilars and how Health Canada regulates them by consulting our new handbook on biosimilars: https://ow.ly/vEKf50Q8iGW

BCBN Feed: Takeda Announces Late-Breaking Data from Phase 2b Study of TAK-279, an Investigational, Oral, Once-Daily TYK2 Inhibitor, in Patients with Active Psoriatic Arthritis at American College of Rheumatology Convergence Annual Meeting https://lnkd.in/gPPkfS7h OSAKA, Japan & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Takeda (TSE:4502/NYSE:TAK) today announced that the company will present positive results from its randomized, double-blind, placebo-controlled, Phase 2b trial evaluating TAK-279, an investigational oral allosteric tyrosine kinase 2 (TYK2) inhibitor with next generation selectivity, in patients with active psoriatic arthritis. These data (Abstract #L12) will... ... [...]

A biosimilar is a drug that’s highly similar to a biologic drug already authorized for sale. Biosimilars have been used safely for years. Health Canada has authorized biosimilar drugs for a range of conditions, including: • cancer • osteoporosis • Crohn’s disease • ulcerative colitis • rheumatoid arthritis Health Canada’s rigorous review standards mean that you can have the same trust in the quality, efficacy and safety of a biosimilar as in any other biologic drug. During #GlobalBiosimilarsWeek, we invite healthcare professionals to learn more about biosimilars and how Health Canada regulates them by consulting our new handbook on biosimilars: https://ow.ly/O0OE50Q8iGV

See you at #AASLD liver meeting 2023 (#TLM23) in Boston Saturday 11th, 1pm-2pm, poster # 2464-C! Physiogenex will be presenting the effects of clinical benchmarks in its new obese hamster model of MetALD to evaluate the impact of drugs targeting MASLD on alcohol intake. With the new liver disease nomenclature, no more NAFLD/NASH: now is the time for MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Steatohepatitis), which turns to MetALD (MASLD+Alcohol-Associated Liver Disease), when MASLD patients have a significant daily alcohol intake. Unfortunately, rat and mouse models of MASLD/MASH do not stand alcohol so they cannot help to model human MetALD for preclinical drug development. Hopefully, hamsters have a natural/high preference for alcohol (indeed they prefer it to water 🙂). This makes an excellent preclinical model for drug efficacy studies! If you are interested in our new and unique preclinical model of MetALD, let’s meet at AASLD this week and/or contact us to setup a meeting and discuss your next study: https://lnkd.in/eR8rpD7H We have a 20-year expertise in preclinical development of drugs targeting metabolic disease, and a 97.5% customer satisfaction rate over the last 3 years. Our expertise – Your success. #preclinicalresearch #drugdevelopment #alcohol #nash

Comparing tocilizumab biosimilar BAT1806/BIIB800 with reference tocilizumab in patients with moderate-to-severe rheumatoid arthritis with an inadequate response to methotrexate: a phase 3, randomised, multicentre, double-blind, active-controlled clinical trial #biosimilars #rheumatoidarthritis #phase3 #tocilizumab #biosimilar https://lnkd.in/dTF3JdYf

Our new paper, published in Pilot and Feasibility studies, reports data from our clinical trial, BIORA-PAIN, which was a feasibility study showing it is possible to stratify for pain in rheumatoid arthritis using pain pressure thresholds. We observed differences in pain thresholds between different treatments including biologics abatacept and adalimumab. Future larger studies are planned to investigate the impact of pain stratification on treatments in rheumatoid arthritis: https://lnkd.in/eiUbGYSA

Parkinson's Disease Drug Therapies in the Clinical Trial Pipeline: 2022 and 2023 Updates by Kevin McFarthing, Gary Rafaloff, Marco Baptista, Leah Mursaleen, Rosie Fuest, Richard Wyse, Simon Stott. 2023 Update: https://lnkd.in/dmAiK-jN and https://lnkd.in/d5F9NHkx 2022 Update: https://lnkd.in/gg4EVhHF #ParkinsonsAwarenessMonth #ParkinsonAwarenessMonth Other relevant LinkedIn posts from our CEO Krzysztof Potempa: 1) Therapeutic strategies for Parkinson disease: beyond dopaminergic drugs (2018) and Novel pharmacological targets for the treatment of Parkinson's disease (2006) https://lnkd.in/gihDRmPb 2. The microbiome–gut–brain axis in Parkinson disease — from basic research to the clinic (2023) https://lnkd.in/gFND4rYE 3. Is Pharma Running Out of Brainy Ideas https://lnkd.in/gApehmPz 4. Grand challenges in global mental health https://lnkd.in/girsRjTb 5. Two decades of new drug development for central nervous system disorders https://lnkd.in/gQ_pZV7N

Novo Nordisk to acquire metabolic disorders specialist Inversago Pharma for $1bn. The deal includes a #CB1 blocker being developed to treat metabolic syndrome and its associated complications. https://lnkd.in/eHwMuJ-N #artificialintelligence #dataanalysis #datascientist #innovation #datastrategy #chiefdataofficer #digitalhealth #digitalhealthplatform #metabolicsyndrome