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Clinical Trial News

SAB Biotherapeutics' SAB-142 Shows Promising Safety Profile in Type 1 Diabetes Trial

  • SAB Biotherapeutics' SAB-142 completes Phase 1 enrollment in healthy volunteers, advancing to enroll patients with type 1 diabetes (T1D).
  • The Phase 1 trial of SAB-142 demonstrates no serum sickness at the target dose of 2.5mg/kg, a key differentiator from rabbit anti-thymocyte globulin.
  • SAB-142, a human anti-thymocyte immunoglobulin, aims to delay the onset and progression of T1D by preserving insulin-producing beta cells.
  • Topline Phase 1 data readout for SAB-142 is expected by the end of the year, with plans for a Phase 2 SAFEGUARD study in new-onset T1D patients.

Akero Therapeutics Doses First Patient in Phase 3 SYNCHRONY Outcomes Trial for MASH Cirrhosis

• Akero Therapeutics has dosed the first patient in its Phase 3 SYNCHRONY Outcomes trial evaluating Efruxifermin (EFX) for compensated cirrhosis (F4) due to MASH. • The SYNCHRONY program includes two other ongoing trials: SYNCHRONY Histology (pre-cirrhotic MASH, F2-F3) and SYNCHRONY Real-World (non-invasively diagnosed MASLD/MASH, F1-F4). • Efruxifermin (EFX) is a novel Fc-FGF21 fusion protein designed to reduce liver fat and inflammation, reverse fibrosis, and improve insulin sensitivity and lipid metabolism. • Topline results from the Phase 2b SYMMETRY study of EFX in compensated cirrhosis due to MASH (F4) are expected in the first quarter of 2025.

Inaxaplin Shows Promise in Addressing APOL1-Mediated Kidney Disease Disparity in Black Americans

• A clinical trial of inaxaplin, a novel drug targeting the APOL1 protein, demonstrated a significant reduction in protein leakage in the urine of patients with serious kidney disease. • The study focused exclusively on African American participants with APOL1 gene variants (G1 and G2) linked to a higher risk of renal failure, addressing a significant racial health disparity. • Vertex Pharmaceuticals is conducting a larger Phase 2/3 trial to investigate inaxaplin's efficacy across multiple kidney disease types in individuals with two APOL1 gene variants. • Insights into APOL1 may also refine kidney transplant policies by using APOL1 genotype instead of race to assess donor kidney viability, potentially increasing the number of available kidneys.

Revolo Bio's '1104 Shows Promise in Resetting Immune Response in Allergic Diseases

  • Revolo Biotherapeutics' '1104 targets antigen-presenting cells, shifting the immune system from a pro-inflammatory to a homeostatic state, potentially inducing remission in allergic conditions.
  • Preclinical and clinical studies validate '1104's mechanism, demonstrating effectiveness in reducing inflammatory cell infiltration and cytokine release in Th2 allergic diseases like eosinophilic esophagitis.
  • '1104's upstream intervention in the inflammatory cascade offers a more durable disease control and improved patient outcomes compared to traditional therapies targeting downstream effects.
  • The antigen-agnostic nature of '1104 suggests potential in addressing unmet needs in various allergic diseases beyond EoE, asthma, and atopic dermatitis, such as food allergies.

Ifinatamab Deruxtecan Shows Promise in Extensive-Stage Small Cell Lung Cancer

• Interim data from the IDeate-Lung01 trial reveal a 54.8% objective response rate with ifinatamab deruxtecan (I-DXd) at 12 mg/kg in patients with extensive-stage small cell lung cancer (ES-SCLC). • The disease control rate (DCR) reached 90.5% in the 12 mg/kg arm, indicating a substantial proportion of patients experienced disease stabilization. • The 12 mg/kg dose of I-DXd has been selected for further evaluation in the second part of the IDeate-Lung01 trial and the phase 3 IDeate-Lung02 study. • Further research is needed to fully assess the toxicity profile of I-DXd and to analyze the complete data from the IDeate-Lung01 study.

Ifinatamab Deruxtecan (I-DXd) in Subjects With Pretreated Extensive-Stage Small Cell Lung Cancer (ES-SCLC)

NCT05280470Active, Not RecruitingPhase 2
Daiichi Sankyo
Posted 3/9/2022

A Phase 3 Study of I-DXd in Subjects with Relapsed SCLC

2023-509628-16-00RecruitingPhase 3
Daiichi Sankyo Inc.
Posted 5/21/2024

Fosun Pharma and MingMed Achieve Key Regulatory Milestones for Novel Therapies

  • Fosun Pharma's subsidiary, Jisimei Pharmaceutical, has received marketing approval in China for its Oxaliplatin Injection, a chemotherapeutic agent developed for cancer treatment.
  • MingMed Biotechnology's subsidiary, Claruvis Pharmaceutical, has secured FDA IND approval for YY003, a liquid formulation of recombinant Botulinum Toxin Type A (BoNT/A).
  • YY003, presented in a pre-filled syringe, is intended for treating glabellar lines and offers a potentially safer and more convenient option for BoNT/A users.

U-Ploid Launches Novel Technology to Combat Age-Related Infertility

  • U-Ploid Biotechnologies introduces a new platform aimed at enhancing egg cell quality, addressing a key factor in the success of in vitro fertilization (IVF).
  • The technology targets the accumulated damage in older eggs, seeking to improve their viability and increase the likelihood of successful pregnancies.
  • Clinical studies are planned to validate the efficacy and safety of U-Ploid's platform, with the goal of widespread adoption in fertility clinics.
  • U-Ploid envisions becoming a global leader in reproductive medicine by providing effective and accessible solutions to age-related fertility decline.

EMA Approves Pre-filled Syringe for Eylea 8 mg, Enhancing AMD and DME Treatment

• The European Medicines Agency (EMA) has approved a pre-filled syringe for administering Eylea 8 mg in the EU, streamlining treatment for eye conditions. • The OcuClick syringe allows ophthalmologists to accurately administer the 70-microliter dose of Eylea 8 mg for neovascular AMD and diabetic macular edema. • Germany will be among the first markets to launch the pre-filled syringe, offering a simpler and more precise application method for healthcare professionals. • Eylea 8 mg has been approved in over 40 markets for treating nAMD and DME, with ongoing applications for further regulatory approvals.

AstraZeneca Completes Clinical Program for Low Global Warming Potential Inhaler

  • AstraZeneca has completed clinical studies for Breztri/Trixeo Aerosphere, transitioning to a next-generation propellant with 99.9% lower Global Warming Potential.
  • Regulatory submissions in Europe, the UK, and China are expected before the end of 2024, marking a significant step in reducing the carbon footprint of pMDIs.
  • The new propellant, HFO-1234ze, developed in collaboration with Honeywell, supports AstraZeneca's Ambition Zero Carbon strategy for emissions reduction.
  • Clinical data confirms the new propellant's bioequivalence and efficacy, ensuring optimal patient outcomes for COPD treatment with the reformulated Breztri.

A Study to Assess the Lung Exposure Bioequivalence of Budesonide, Glycopyrronium, & Formoterol (BGF) Metered Dose Inhaler (MDI) With a Next-generation Propellant (NGP) With a Spacer, BGF MDI Hydrofluoroalkane (HFA) With a Spacer, as Well as BGF MDI NGP Without a Spacer

NCT06340581WithdrawnPhase 1
AstraZeneca
Posted 10/17/2024

Immunovant's Batoclimab Shows Promise in Graves' Disease Phase II Trial; IMVT-1402 Pivotal Trial Planned

  • Immunovant's batoclimab demonstrated a 76% response rate in Graves' disease patients uncontrolled on antithyroid drugs (ATDs) after 12 weeks of high-dose treatment.
  • A 56% ATD-free response rate was achieved with high-dose batoclimab, indicating potential for patients to taper off their existing medication.
  • Immunovant plans to initiate a pivotal trial for IMVT-1402 in Graves' disease by the end of the year, following FDA clearance of the IND application.
  • Analysis suggests 25-30% of Graves’ disease patients remain uncontrolled on ATDs, representing a significant commercial opportunity.

A Proof-of-Concept Study to Assess Batoclimab in Participants With Graves' Disease

NCT05907668Active, Not RecruitingPhase 2
Immunovant Sciences GmbH
Posted 5/15/2023

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