Amylyx Pharmaceuticals’ Post

Novel pain relief drug enters Phase I trials The first participants have been enrolled in a first-in-human Phase I clinical trial for a nociceptin (NOP) receptor agonist, which it is hoped will treat chronic pain without the potential for abuse.  The trial will include 90 healthy volunteers and aims to demonstrate a favourable safety and tolerability profile and to confirm the pharmacokinetic characteristics of the compound after single and multiple ascending doses.  The results of the trial are expected in Q3 2025. https://lnkd.in/es8bTD_P #ClinicalTrials #DrugDiscovery #ChronicPain

In the pursuit of effective SARS-CoV-2 therapies, understanding the molecular interactions of antiviral drugs is critical. For this case study, the Qgen Lab interface begins by showcasing a 3D model of Lopinavir, a key antiviral drug. Users are then presented with a comprehensive list of drugs targeting the virus. Upon selecting Lopinavir, detailed insights are revealed, including both 2D and 3D structures, enabling a clear view of the drug’s molecular composition and its therapeutic relevance. #healthcaredesign #uxui #patientcare #medicalinnovation #userexperience #drugdiscovery

Novo Nordisk’s semaglutide has achieved positive outcomes in a Phase 3 trial for metabolic dysfunction-associated steatohepatitis (previously known as nonalcoholic steatohepatitis).   The Essence trial demonstrated significant improvements in liver fibrosis and resolution of steatohepatitis, successfully meeting primary endpoints. With this breakthrough, Novo Nordisk aims to file for regulatory approval in the U.S. and Europe by 2025.   These promising results highlight the expanding role of GLP-1 therapies in many indications, including this complex field, which has limited treatment options.   Read more here: https://lnkd.in/ed5bvzDk   Find the clinical evidence for semaglutide on DRUGDOCS®: https://lnkd.in/gjy4C8QW   #MASH #NAFLD #GLP1 #LiverDisease

In case you missed it, we have just launched our new advanced lung FMT assay 🫁 The advanced high-throughput high-sensitivity lung FMT assay facilitates customisable and rapid assessment of the efficacy of anti-fibrotic drug candidates. Building on the success of our existing FMT assay, this advanced version provides data at higher-resolution, with simultaneous assessment of four separate data outputs for more accurate selection and predictivity of drug effects on pulmonary fibrosis. Find out more 👉 https://lnkd.in/ePdxzcZm #Newcells #DrugDevelopment #FMT #LungAssay

This Friday an FDA advisory committee will meet to discuss the results of a new meta-analysis on the use of minimal residual disease (MRD) as an endpoint to support the accelerated approval of new drugs in multiple myeloma (MM). Currently, drugs in MM are approved based on clinical benefit endpoints, leading to lengthy clinical trials and drug approval timelines and ultimately delays in offering patients potentially beneficial treatments. MRD testing can measure a patients response to treatment by the use of sensitive technologies which measure the level of tumor cells in a patient’s blood. The use of MRD results as an endpoint for drug approval would allow MRD testing to be used to demonstrate drug efficacy instead of clinical response thus shortening clinical trial and drug development times. A recent Diaceutics report on the use and perceptions of MRD found the majority of hematoncologists were comfortable with the use of MRD as a surrogate endpoint in clinical trials. If implemented, this would represent a paradigm shift in the approval of novel therapies. While this discussion is currently limited to MM, the scope for using MRD in drug development and the management of patients is currently being investigated in multiple haematological and solid tumor indications. MRD has the potential to become routine clinical practice in the management of oncology indications and would enable the early detection of disease relapse and allow patient treatments to be adapted accordingly. View the Diaceutics report on MRD at https://lnkd.in/eKu4imxW

Breakthrough approach on MRD which could significantly impact timelines on getting new treatments to patients. If you have not accessed the Diaceutics report on MRD read more at the link below and get in touch. Dr Bob Holt #precisionmedicine #patients #FDA #MRD #cancer

Explore Our Novel PTK7 BsADC Asset: PTK7 x TROP2 BsADC (BCG033) Our novel PTK7 x TROP2 BsADC (BCG033) aims to improve the therapeutic window and efficacy for metastatic TNBC, addressing limitations seen with TRODELVY. This asset has demonstrated superior anti-tumor efficacy compared to benchmark ADCs in vivo. Development Stage: PCC. Partner with us to leverage the innovative therapeutic for your pipeline. #Biocytogen #PTK7 #TROP2 #bsADC #Immunotherapy #BiotechInnovation #DrugDiscovery #HealthcareInnovation

With the latest coming out of AAIC, follow FirstWord’s analysis of the prospects for GLP-1 agonists in Alzheimer’s disease (AD), how Eli Lilly is jostling for position against Biogen and Eisai, and the latest in novel strategies to take on neurodegeneration...

Preliminary results of ph IIB ORIGIN trial of placebo vs Atacicept (binds BAFF & APRIL)in 166 pts w/ IgA Nephropathy (Berger’s Dz) Gd-IgA1, hematuria, and UPCR (vs PBO) in the blinded 1st 36 weeks of the trial.

Phase III trial results of novel triple combination pill