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Clinical Trial News

Acelyrin's Lonigutamab Shows Promise in Thyroid Eye Disease Phase 1/2 Trial

• Acelyrin's lonigutamab, a subcutaneous anti-IGF-1R antibody, demonstrated clinical responses in patients with thyroid eye disease (TED) in a Phase 1/2 trial. • The trial (NCT05683496) evaluated the safety and efficacy of lonigutamab in three cohorts with active TED, using varying dosing regimens. • Lonigutamab binds to a distinct IGF-1R epitope, leading to receptor internalization and potentially improved clinical response durability. • The data were presented at the Endocrine Society’s Annual Meeting (ENDO 2024) as a late-breaking oral presentation.

Efficacy and Safety of Lonigutamab in Subjects With Thyroid Eye Disease (TED)

NCT05683496CompletedPhase 1
ACELYRIN Inc.
Posted 2/14/2023

FDA Panel Supports MRD as Endpoint for Accelerated Approval in Multiple Myeloma

  • The FDA's Oncologic Drugs Advisory Committee supports using minimal residual disease (MRD) as an endpoint for accelerated approval of multiple myeloma treatments.
  • This decision addresses the significant unmet need for early endpoints that predict long-term clinical benefits in myeloma patients.
  • Using MRD could drastically reduce drug development timelines, potentially accelerating access to effective therapies for patients.
  • The approach offers the opportunity to develop potentially curative therapies, crucial given the lack of curative treatments currently available.

CDC Updates Guidelines on Doxycycline Post-Exposure Prophylaxis for STIs

• The CDC recommends doxycycline post-exposure prophylaxis (doxy PEP) for MSM and TGW with a recent history of bacterial STIs to reduce infection risk. • Doxy PEP involves taking 200 mg of doxycycline within 72 hours after sex, but it should be part of a comprehensive sexual health strategy. • Clinical trials have demonstrated significant reductions in chlamydia, syphilis, and gonorrhea among MSM and TGW using doxy PEP. • Potential harms, including antimicrobial resistance, necessitate ongoing monitoring and further research to assess long-term effects.

Spineart Receives FDA 510(k) Clearance for SCARLET AC-Ti Anterior Cervical Cage with Advanced Ti-LIFE Technology

  • Spineart announced FDA 510(k) clearance for its SCARLET AC-Ti secured anterior cervical cage, building on a decade of experience with the SCARLET system.
  • The device features MIMETIX morphometric profile developed with digital vertebrae models to optimize implant-endplate contact surface and allows fixation with screws and anchors.
  • SCARLET AC-Ti utilizes Spineart's proprietary Ti-LIFE additive manufacturing technology, creating a porous structure that closely mimics trabecular bone architecture.
  • The approval represents Spineart's commitment to innovation and continuous evolution of their most successful spinal surgery products.

FDA Grants Accelerated Approval to Krazati Plus Cetuximab for KRAS G12C-Mutated Colorectal Cancer

Drug ApprovalPrecision MedicineTargeted Therapy
  • The FDA granted accelerated approval to Krazati (adagrasib) plus cetuximab for adults with KRAS G12C-mutated locally advanced or metastatic colorectal cancer who have received prior standard chemotherapy treatments.
  • The combination therapy targets a specific genetic mutation and is approved for patients whose tumors are determined to have the KRAS G12C mutation by an FDA-approved test.
  • The most common adverse reactions include rash, nausea, diarrhea, vomiting, fatigue, and musculoskeletal pain, occurring in at least 20% of patients.
  • This approval represents a significant advancement in precision medicine for colorectal cancer patients with this specific genetic alteration.

Johnson & Johnson to Acquire Yellow Jersey Therapeutics for $1.25 Billion, Bolstering Atopic Dermatitis Pipeline

  • Johnson & Johnson will acquire Yellow Jersey Therapeutics for $1.25 billion, gaining rights to NM26, a Phase 2-ready bispecific antibody for atopic dermatitis.
  • NM26 targets both IL-4Rα and IL-31, addressing inflammation and itch, potentially offering advantages over existing treatments like Dupixent.
  • The acquisition aligns with J&J's strategy to expand its immunology portfolio with differentiated bispecifics, following recent deals in oncology and immunology.
  • Numab Therapeutics' MATCH™ technology platform, used to develop NM26, is validated by this deal, highlighting its potential for creating novel multi-specific antibodies.

Rosacea Pipeline Analysis 2024: Insights into Therapeutics Development

The 2024 Rosacea Pipeline Analysis report by DelveInsight highlights the ongoing clinical development activities and growth prospects in the Rosacea Therapeutics Market. It details the involvement of over 25 key pharma and biotech companies, including Sol-Gel Technologies, in developing more than 25 pipeline drugs. The report covers various stages of clinical development, mechanisms of action, and molecule types, offering a comprehensive overview of the current and future landscape of Rosacea treatment.

RemeGen's Telitacicept Receives Priority Review for Myasthenia Gravis Treatment Following Successful Phase III Trial

Orphan Drug
  • RemeGen's Telitacicept received priority review from China's NMPA for treating generalized myasthenia gravis after achieving its primary endpoint in a Phase III clinical trial.
  • The dual-target fusion protein demonstrated favorable efficacy and safety profiles with continuous reduction of clinical symptoms in gMG patients compared to placebo.
  • Myasthenia gravis affects approximately 1.146 million individuals worldwide, with around 217,000 in China, and currently has no definitive treatment available.
  • Telitacicept has already received breakthrough therapy designation from China's NMPA and orphan drug plus fast track designations from the US FDA.

Pneumagen's Neumifil Shows Promising Results in Phase 2 Influenza Prevention Trial

  • Pneumagen's intranasal antiviral drug Neumifil demonstrated clinically significant reductions in both incidence and severity of symptomatic influenza infections in a Phase 2 controlled human infection model study.
  • The broad-spectrum antiviral, developed using proprietary GlycoTarge technology, works by directly binding to viral pathogens and preventing their entry into host cells.
  • Based on these positive results presented at the American Thoracic Society meeting, Pneumagen plans to advance Neumifil into further clinical studies, including evaluation for reducing COPD exacerbations in high-risk patients.

EMA Validates Marketing Applications for HLX14 Denosumab Biosimilar in Osteoporosis Treatment

Monoclonal Antibody
  • The European Medicines Agency has validated marketing authorization applications for HLX14, an investigational biosimilar to denosumab (Prolia/Xgeva) developed by Shanghai Henlius Biotech and Organon for osteoporosis treatment.
  • The applications are supported by positive phase 3 trial data showing HLX14 met both primary efficacy and pharmacodynamic endpoints when compared to reference denosumab in postmenopausal women with osteoporosis.
  • With an estimated 32 million Europeans aged 50 or above having osteoporosis in 2019, including 25.5 million women, this biosimilar could provide expanded treatment access for this significant patient population.

A Study to Evaluate the Efficacy and Safety of HLX14 vs. Denosumab Prolia® in Postmenopausal Women With Osteoporosis at High Risk of Fracture

NCT05352516Active, Not RecruitingPhase 3
Shanghai Henlius Biotech
Posted 6/17/2022

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