October 3, 2024 - 🧬 [nGram] Today’s Neurology Scoop: Charles River & Lundbeck AI Drug Discovery, SetPoint MS Study

1. Charles River and Lundbeck enter agreement utilizing AI-powered Logica to advance the discovery of novel drugs for neurological disease

   • Charles River Laboratories and Lundbeck have partnered to use Logica, an AI-powered drug discovery solution, for neurological disease research.
   • Logica integrates Valo Health's AI-powered Opal Computational Platform with Charles River's drug discovery expertise.
   • The collaboration aims to create optimized small molecules for novel neurological therapies.
   • Lundbeck will leverage AI-driven approaches to address drug design challenges and accelerate the translation of targets into drug candidates.
   Read more
   
   

2. First patient dosed in phase 3 trial of UGN-103 for bladder cancer

   • UroGen Pharma has dosed the first patient in a Phase 3 trial for UGN-103, a mitomycin-based formulation for low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
   • The UTOPIA study is a single-arm, multicenter trial aiming to enroll 87 patients, assessing efficacy by complete response rate at three months.
   • UGN-103 uses UroGen’s RTGel technology, designed for sustained drug release, potentially improving therapeutic profiles.
   • The trial follows the potential FDA approval of UGN-102, with UGN-103 planned to launch subsequently.
   Read more
   
   

3. SetPoint Medical receives FDA IDE approval for pilot study in multiple sclerosis

   • SetPoint Medical has received FDA IDE approval to study its neuroimmune modulation platform in relapsing-remitting multiple sclerosis (RRMS).
   • The pilot study will be multicenter, randomized, double-blind, and sham-controlled, enrolling up to 60 patients in the U.S. starting in 2025.
   • The SetPoint System involves an implantable device that stimulates the vagus nerve to activate anti-inflammatory pathways.
   • The device has also been granted Breakthrough Device Designation and is part of the TPLC Advisory Program for RRMS treatment.
   Read more
   
   

4. Gilead signs licensing agreements to increase access to lenacapavir for HIV prevention

   • Gilead has signed royalty-free licensing agreements with six manufacturers to produce generic lenacapavir for 120 countries.
   • The agreements aim to provide access to lenacapavir for HIV prevention and treatment in resource-limited countries.
   • Gilead plans to begin regulatory filings for lenacapavir for PrEP by the end of 2024, following successful Phase 3 trials.
   • The company is prioritizing registration in 18 high-incidence countries to provide lenacapavir until generics are available.
   Read more