Alimentary/Metabolic
The US election result brought stock market volatility especially to pharma and biotech companies but the poster children for approved GLP-1 agonists and vaccines were initially the hardest hit.
The company discontinued the Phase II STRIDES study testing azelaprag as monotherapy and in combination with Lilly’s tirzepatide in obesity.
Zepbound led to greater weight loss versus Wegovy in a Phase III trial, bolstering its position as the superior product in the fast-growing obesity space.
Emerging Company Profile: Resalis will soon start human trials of an oligonucleotide targeting a microRNA that is overexpressed in obese mice, but much remains to be proven in humans.
Hua Medicine’s HuaTangNing (dorzagliatin), the world’s first approved glucokinase activator, has apparently fallen short of restoring Bayer to its pre-2020 frontrunner position in China’s market for oral type 2 diabetes drugs, and the two companies' alliance is now set to be dissolved.
Much anticipated Phase II results in obesity for Amgen’s GLP-1 agonist/GIP antagonist showed up to 20% weight loss, but without detailed data the drug’s competitiveness is hard to ascertain.
Boston Pharma may be rising in the FGF21 space, while Viking could be formidable competition for Madrigal in the THRβ agonist class. Akero will soon report potentially groundbreaking data in cirrhotic NASH.
The firm revealed that an analysis of its Phase III ESSENCE trial combining fibrosis reduction and NASH resolution showed a higher effect over placebo than in Madrigal’s pivotal trial.
Following Phase III safety and cash problems, Inventiva has its eye on lanifibranor becoming the second oral agent approved in NASH. Former Intercept CEO Mark Pruzanski is advising the effort.
Indian firms Lupin and Aurobindo lay out global plans for GLP-1 agonists, as Aurobindo also updates on its biosimilar ambitions as they report results for fiscal Q2.
At a recent conference, executives from Boehringer and Amgen laid out their expectations for the future of obesity and how they intend to navigate the changes.
The Denmark-based major intends to build on its heritage in diabetes and is keen to hear from innovators in a space where prevalence is on the rise but is not being served by improved new products.
A single molecule was responsible for nearly three quarters of the Danish group’s DKK71.3bn ($10.3bn) Q3 revenues.
Viking’s dual GLP-1/GIP agonist VK2735 continues to make headlines for strong efficacy and tolerability with oral and injectable formulations. CinFina reports progress with two new MOAs.
The blockbuster GLP-1 analog demonstrated a capability for fibrosis reduction and disease resolution in the Phase III ESSENCE study. The firm plans to file for approval in 2025.
Panels at the recent BioFuture conference focused on the next breakthroughs in areas such as oncology and neurodegenerative diseases, continuing challenges to GLP-1 agonists, financing and how use of AI is taking shape.
The UK group began more clinical trials last year than any other company, a new report from Citeline has found.
Lanreotide supply challenges could impact Cipla’s US revenues in the coming quarter, while the firm hopes it can seize emerging opportunities in the GLP-I segment in India, where Novo Nordisk and Eli Lilly are progressing filings for their blockbuster products.
Third quarter sales of the diabetes and obesity drug tirzepatide surpassed $4bn but missed analyst consensus estimates, triggering questions from investors.
Strides is to supply semaglutide and liraglutide to generics companies amid global capacity constraints and drug shortages, ahead of loss of exclusivity. An ability to make drug-device combinations has meant it has contracts for seven of the eight GLP-1 agonists, and counting