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Clinical Trial News

Vera Therapeutics Completes Enrollment for Atacicept Phase 3 ORIGIN 3 Trial in IgAN

  • Vera Therapeutics has completed enrollment for the primary endpoint in its pivotal Phase 3 ORIGIN 3 trial of atacicept for IgAN patients.
  • The ORIGIN 3 trial is a global, multicenter, randomized, double-blind, placebo-controlled study evaluating atacicept's safety and efficacy.
  • Topline data from the ORIGIN 3 trial, which enrolled 200 participants, is expected in Q2 2025, supporting regulatory submission.
  • Vera anticipates presenting 96-week data from the ORIGIN Phase 2b clinical trial of atacicept in IgAN in Q4 2024.

Atacicept in Subjects With IgA Nephropathy

NCT04716231Active, Not RecruitingPhase 3
Vera Therapeutics, Inc.
Posted 5/23/2023

Richmond Clinical Trials Seeks Volunteers for RSV and Norovirus Vaccine Studies

  • Richmond Clinical Trials is recruiting participants aged 19 and older with managed conditions like asthma, COPD, or diabetes for vaccine studies.
  • The trials aim to develop a combination vaccine for RSV and hMPV, viruses impacting lung health, and a vaccine against Norovirus, a highly contagious gastrointestinal virus.
  • Participants will contribute crucial data to assess vaccine safety and efficacy, with reimbursement provided for their time in the clinical trials.
  • These trials highlight the critical role of volunteers in advancing medical knowledge and developing effective treatments for prevalent viral diseases.

Three Biotech Firms Secure $700M in Major IPO Wave, Signaling Market Momentum

• Bicara Therapeutics leads the IPO surge with a $315 million raise for its cancer therapeutics program, marking the third-largest biotech IPO of 2024.
• Zenas BioPharma successfully raised $225 million to advance its immunology pipeline, while MBX Biosciences secured $163 million for endocrine and metabolic disease research.
• The triple IPO event represents a significant milestone in 2024's biotech market, though overall IPO activity remains below pre-pandemic levels with 18 biotechs going public this year.

FDA Approves Arthroscopic Delivery for MACI Knee Cartilage Repair

  • The FDA has approved a supplemental Biologics License Application for arthroscopic delivery of MACI, an autologous cultured chondrocytes on a porcine collagen membrane, for knee cartilage repair.
  • This approval expands MACI's delivery options, offering a less invasive arthroscopic approach for repairing symptomatic cartilage defects up to 4 cm2.
  • MACI Arthro is the only restorative biologic cartilage repair product approved for arthroscopic administration, potentially increasing market penetration.
  • Vericel Corporation anticipates that MACI Arthro will support sustained revenue growth by addressing a larger segment of the treatable market.

Trimodal Therapy Shows Promise for Recurrent High-Grade T1 Bladder Cancer

  • A phase 2 trial indicates trimodal therapy as a potential alternative to radical cystectomy for recurrent high-grade T1 bladder cancer after BCG failure.
  • At a median follow-up of 5.1 years, 88% of patients avoided radical cystectomy 3 years post-trimodal therapy.
  • The 3-year and 5-year overall survival rates were 69% and 56%, respectively, with distant metastasis rates of 12% and 19%.
  • While the study was limited by a small cohort, results suggest trimodal therapy offers high bladder salvage rates comparable to cystectomy.

Lenacapavir Shows High Efficacy in HIV Prevention, Faces Cost Accessibility Concerns

• Lenacapavir, a long-acting injectable HIV prevention drug, demonstrated 89% higher efficacy than daily oral medication in a key clinical trial. • Gilead Sciences' lenacapavir, dosed every six months, showed 100% efficacy in cisgender women, marking it as a potential game-changer. • Despite promising results, the high cost of lenacapavir raises concerns about equitable access and potential widening of racial disparities. • Gilead plans to seek FDA approval for lenacapavir as PrEP by year-end, with potential market availability by mid-to-late 2025.

Mepolizumab Reduces COPD Exacerbations in Phase III MATINEE Trial

  • Mepolizumab significantly reduced moderate to severe exacerbations in COPD patients with type 2 inflammation in the Phase III MATINEE trial.
  • The study involved 806 participants aged 40 and older, who received either mepolizumab or placebo in addition to standard care.
  • Mepolizumab, an interleukin-5 antagonist monoclonal antibody, demonstrated a clinically meaningful reduction in exacerbation rates over 104 weeks.
  • The safety profile of mepolizumab in the MATINEE trial was consistent with previous clinical trials, supporting its potential use in COPD.

Mepolizumab as Add-on Treatment IN Participants With COPD Characterized by Frequent Exacerbations and Eosinophil Level

NCT04133909CompletedPhase 3
GlaxoSmithKline
Posted 10/30/2019

HighTide Therapeutics' HTD1801 Shows Promise in Type 2 Diabetes and MASH

• HighTide Therapeutics presented Phase 2 data on HTD1801 at EASD 2024, demonstrating benefits in both Chinese and Western patients with type 2 diabetes mellitus (T2DM). • HTD1801, a berberine ursodeoxycholate formulation, improved glycemic control, cardiometabolic parameters, and liver health in T2DM patients, irrespective of ethnicity. • The data suggests HTD1801 may offer a unique therapeutic approach for patients with metabolic diseases and severe insulin resistance by enhancing glucose and fat utilization. • Phase 3 trials of HTD1801 in T2DM are fully enrolled, with results expected in 2025, potentially offering a new treatment option for this patient population.

Effects of Berberine Ursodeoxycholate (HTD1801) Versus Dapagliflozin in Patients with Type 2 Diabetes Inadequately Controlled with Metformin

NCT06415773Active, Not RecruitingPhase 3
HighTide Biopharma Pty Ltd
Posted 6/4/2024

Efficacy and Safety of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes

NCT06350890Active, Not RecruitingPhase 3
HighTide Biopharma Pty Ltd
Posted 11/5/2023

TC BioPharm's TCB008 Shows Promising Safety Profile in ACHIEVE Trial for AML/MDS

  • TC BioPharm announced the first patient completed the full dosing regimen of TCB008 in the ACHIEVE Phase 2b trial without drug-related adverse events.
  • The ACHIEVE trial is evaluating TCB008's efficacy in patients with refractory or relapsed AML or MDS/AML.
  • Preliminary data suggests TCB008 is well-tolerated at the 5mL dose, supporting the trial's safety objectives.
  • The company anticipates releasing a full data set, including primary and secondary endpoints, in the first half of 2025.

High Adderall Doses Linked to Increased Psychosis Risk, Study Finds

  • A new study links high doses of Adderall (above 40mg) to a fivefold increased risk of first-time psychosis or mania episodes, particularly in young adults.
  • Researchers at McLean Hospital analyzed electronic health records, finding an 81% attributable risk of psychosis or mania in high-dose amphetamine users.
  • The study suggests careful dose consideration when prescribing stimulants, especially for patients with psychosis or mania risk factors, while methylphenidate showed no significant risk increase.
  • The findings highlight the need for cautious prescribing practices and monitoring of patients on stimulant medications, balancing benefits against potential psychiatric risks.

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