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Clinical Trial News

Aligos Therapeutics Strengthens CMC Leadership with Industry Veteran Ahead of Phase 2 Trial

  • Aligos Therapeutics has appointed Kieron Wesson, PhD as Vice President, Head of Chemistry Manufacturing Controls (CMC), bringing over 20 years of pharmaceutical development experience to the company.
  • The appointment comes at a strategic time as Aligos prepares to begin its Phase 2 study of ALG-000184 in mid-2025 for liver and viral diseases.
  • Dr. Wesson previously led CMC operations at Kezar Life Sciences and AN2 Therapeutics, and supported the approval and commercial launches of Kerydin® and Eucrisa® at Anacor Pharmaceuticals.
  • The hire reinforces Aligos' commitment to advancing its pipeline of therapeutics targeting chronic hepatitis B virus infection, metabolic dysfunction-associated steatohepatitis (MASH), and coronaviruses.

AbbVie's Atogepant Demonstrates Superior Tolerability and Efficacy Over Topiramate in Phase 3 Migraine Prevention Trial

  • AbbVie's Phase 3 TEMPLE study shows atogepant (QULIPTA/AQUIPTA) achieved significantly fewer treatment discontinuations due to adverse events compared to topiramate for migraine prevention.
  • The study met all primary and secondary endpoints, with 64.1% of atogepant patients achieving ≥50% reduction in monthly migraine days versus 39.3% on topiramate.
  • Results support CGRP pathway inhibitors as first-line preventive treatment options for migraine, addressing significant unmet medical needs in this debilitating neurological condition.

Comparative Study of Oral Atogepant Versus Oral Topiramate to Assess Adverse Events in Adult Participants With Migraine

NCT05748483Active, Not RecruitingPhase 3
AbbVie
Posted 10/7/2023

A Study of Eptinezumab in Participants With Migraine and Medication Overuse Headache

NCT05452239CompletedPhase 4
H. Lundbeck A/S
Posted 7/1/2022

Draig Therapeutics Emerges from Stealth with $140M to Advance Novel Neuropsychiatric Therapies

  • Draig Therapeutics launched with $140 million in Series A funding to develop next-generation treatments for neuropsychiatric disorders, marking the largest commercial investment in Welsh research to date.
  • The company's lead candidate DT-101, an AMPA receptor positive allosteric modulator for major depressive disorder, will enter Phase 2 trials in 2025 following successful Phase 1 results in over 60 subjects.
  • Founded by Cardiff University professors targeting glutamate and GABA neurotransmitter pathways, Draig aims to address significant unmet medical needs in neuropsychiatric conditions with improved safety profiles.
  • The funding round was led by Access Biotechnology with participation from major investors including Canaan Partners, SR One, and Sanofi Ventures, supporting advancement of multiple pipeline candidates.

SK Biopharmaceuticals Partners with PhnyX Lab to Deploy AI-Powered Drug Development Platform

AI
  • SK Biopharmaceuticals signed a strategic agreement with AI startup PhnyX Lab to establish an AI-powered drug development framework using the Cheiron generative AI platform.
  • The collaboration will automate key processes including literature searches, data analysis, and regulatory documentation for clinical trial initiation to reduce development time and costs.
  • The partnership represents what SK Biopharmaceuticals calls a "full-scale AI transformation" of its drug development workflow, building on its existing Huble AI platform.
  • Cheiron integrates with official regulatory databases from the FDA and Korea's Ministry of Food and Drug Safety to deliver high accuracy in pharmaceutical operations.

Senate Republicans Drop Orphan Drug Exemptions from Trump Tax Bill, Dealing Blow to Rare Disease Drug Development

Rare Disease
  • Senate Republicans excluded the Orphan Cures Act from their version of Trump's "One Big Beautiful Bill Act," removing provisions that would have exempted multi-indication orphan drugs from Medicare price negotiations.
  • The bipartisan Orphan Cures Act aimed to address concerns that current Inflation Reduction Act provisions discourage rare disease drug development, with data showing a 48% drop in drugs receiving second orphan designations post-IRA.
  • Patient advocacy groups celebrated the Senate's decision, arguing the act was an industry attempt to evade necessary drug price negotiations and maintain lower costs for Medicare beneficiaries.
  • The Senate's departure from the House version indicates further legislative revisions are likely before Republicans' July 4 target deadline for final passage.

Sanofi's Tzield Debuts in China as First FDA-Approved Therapy to Delay Type 1 Diabetes Onset

Drug Approval
  • Sanofi's Tzield, the world's first FDA-approved therapy for postponing type 1 diabetes onset, has been prescribed in Boao, Hainan province, marking its debut among the first batch in Asia.
  • The innovative treatment delays progression from stage 2 to stage 3 type 1 diabetes in patients aged 8 or older, with 14-day continuous usage capable of postponing onset by nearly three years.
  • This breakthrough represents a shift from passive treatment to active intervention for type 1 diabetes in China, protecting pancreatic islet function and allowing patients symptom-free time without insulin therapy.
  • China has approximately 600,000 type 1 diabetes patients, ranking third globally, with high incidence among children and adolescents aged 10-14.

INOVIQ's CAR-Exosome Therapy Achieves 88% Cancer Cell Kill Rate in Preclinical Study

  • INOVIQ's CAR-exosome therapy demonstrated 87.8% cell death in triple-negative breast cancer and non-small-cell lung cancer cells within 96 hours in vitro studies.
  • The therapy uses chimeric antigen receptor natural killer cells derived from extracellular vesicles, offering potential advantages over traditional CAR-T cell therapies for solid tumors.
  • The company plans to advance to in vivo mouse studies later this year, followed by human clinical trials, targeting cancers with limited current treatment options.

Mercalis and PharmaCord Merge to Form Valeris, Creating Integrated Therapy Commercialization Platform

  • Mercalis and PharmaCord have officially merged to form Valeris, a new entity focused on improving therapy delivery for life sciences companies.
  • The merger combines Mercalis's healthcare commercialization expertise with PharmaCord's patient support services and pharmaceutical distribution capabilities.
  • Valeris aims to streamline processes that help pharmaceutical companies navigate the complexities of bringing medical therapies from development to patients.
  • The integrated platform is expected to enhance solutions for therapy commercialization while maintaining focus on efficiency and accessibility.

Novartis and MSN Settle Entresto Patent Dispute, Boosting Divi's Laboratories Outlook

  • Novartis and MSN Laboratories have settled the '659 patent dispute regarding Entresto, a blockbuster heart failure drug generating $6 billion in annual sales for Novartis.
  • The legal battle now moves to the next patent expiring in November 2026, with regulatory exclusivity extending until May 2027, potentially delaying generic competition.
  • Divi's Laboratories, a key API supplier for Entresto, could earn ₹700 crore in FY26 if MSN launches generics in July 2025, or ₹1,000-1,200 crore if the launch is delayed.
  • The settlement could lead to upward revisions in Divi's financial estimates for FY26 and FY27, with shares gaining 1.7% following the news.

FDA Approves First Simultaneous Whole Exome and Transcriptome Cancer Test for Precision Oncology

FDA Approval
  • Caris Life Sciences received FDA approval for MI Cancer Seek, the first simultaneous whole exome and whole transcriptome sequencing-based companion diagnostic test for solid tumors.
  • The test demonstrates over 97% agreement with other FDA-approved diagnostic tools and can analyze both DNA and RNA from minimal tissue samples as small as 50 ng.
  • MI Cancer Seek includes companion diagnostic indications for multiple targeted therapies across breast, lung, colon, melanoma, and endometrial cancers for both adult and pediatric patients.
  • The comprehensive assay detects key biomarkers including PIK3CA, EGFR, BRAF, and KRAS/NRAS mutations while measuring tumor mutational burden and microsatellite instability.

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