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Clinical Trial News

Annovis Bio's Buntanetap Shows Cognitive Improvement in Parkinson's Subgroup

• Annovis Bio's buntanetap demonstrated significant cognitive improvements in Parkinson's patients diagnosed more than three years ago, according to Phase III trial subgroup analysis. • The study highlighted improvements in MDS-UPDRS Part II, Part III, and Phase II+III scores with the 20mg dose of buntanetap compared to placebo. • A separate subgroup analysis showed significant improvements in patients with postural instability and gait difficulty (PIGD), a subset linked to faster disease progression. • Annovis plans to advance buntanetap into a longer study to verify symptomatic improvements and explore its potential disease-modifying properties.

A Dose-ranging Study to Investigate Efficacy of Buntanetap in Mild to Moderate AD

NCT05686044CompletedPhase 2
Annovis Bio Inc.
Posted 4/1/2023

A Double-blind Study to Investigate Efficacy and Safety of Buntanetap Compared With Placebo in Participants With Early PD

NCT05357989CompletedPhase 3
Annovis Bio Inc.
Posted 8/3/2022

Twice-Yearly Lenacapavir Injections Show 100% Efficacy in Preventing HIV in Women

  • A clinical trial in South Africa and Uganda demonstrated that lenacapavir, administered via injection every six months, provided complete protection against HIV infection in young women.
  • The Purpose 1 trial compared lenacapavir to daily oral PrEP medications, Truvada (F/TDF) and Descovy (F/TAF), with lenacapavir showing significantly higher efficacy.
  • The trial's independent data safety monitoring board recommended halting the blinded phase due to the clear benefit of lenacapavir, offering all participants a choice of PrEP.
  • Gilead Sciences, the drug developer, plans to submit the trial results to regulatory bodies and the WHO, with hopes of incorporating lenacapavir into HIV prevention guidelines.

FDA Approves Lilly's Kisunla (donanemab-azbt) for Early Symptomatic Alzheimer's Disease

  • The FDA has approved Kisunla (donanemab-azbt) for treating early symptomatic Alzheimer's disease, including mild cognitive impairment and mild dementia stages.
  • Kisunla is the first amyloid plaque-targeting therapy allowing treatment cessation upon plaque removal, potentially reducing costs and infusion frequency.
  • Clinical trials showed Kisunla significantly slowed cognitive decline by 35% in early-stage patients and reduced amyloid plaques by up to 84% over 18 months.
  • Treatment with Kisunla carries potential side effects, including amyloid-related imaging abnormalities (ARIA) and infusion-related reactions, requiring careful monitoring.

FDA Approves New Endometrial Cancer Therapies, Expanding Treatment Options

The FDA has recently approved Imfinzi and Keytruda, both in combination with chemotherapy, for treating endometrial cancer, offering new hope and options for patients. These approvals are significant for patients with advanced or recurrent endometrial cancer, particularly those with mismatch repair deficient (dMMR) or proficient (pMMR) cancers. The article discusses the differences between these therapies and their potential impact on disease control and patient outcomes.

FDA Issues Draft Guidance on Diversity Action Plans for Clinical Studies

  • The FDA released draft guidance on Diversity Action Plans (DAPs) to boost enrollment of underrepresented groups in clinical trials, as mandated by FDORA 2022.
  • DAPs should detail sponsors' rationale and goals for enrollment by age, ethnicity, sex, and race, and describe strategies to meet these goals.
  • The guidance applies to Phase 3 and pivotal clinical studies for drugs, biologics, and certain devices, with implementation starting 180 days post-final guidance publication.
  • The FDA encourages sponsors to publicly share their DAP strategies and enrollment goals in accessible language to enhance transparency and public engagement.

FDA Accepts Vertex's NDA for Next-Gen Cystic Fibrosis Triple Therapy

  • The FDA has accepted Vertex's NDA for vanzacaftor/tezacaftor/deutivacaftor, a triple combination therapy for cystic fibrosis (CF) patients aged 6 and older.
  • This therapy targets those with at least one F508del mutation or another mutation responsive to the drug in the CFTR gene.
  • The FDA granted priority review, setting a PDUFA target action date for January 2, 2025, potentially expediting the availability of this treatment option.
  • Clinical trials suggest vanzacaftor could lower sweat chloride levels below the diagnostic threshold for CF, potentially improving patient outcomes.

FDA Approves First Bispecific T-Cell Engager for Solid Tumors and Expands Indications for Immunotherapies

• The FDA granted accelerated approval to tarlatamab (Imdelltra), the first bispecific T-cell engager for extensive-stage small cell lung cancer (ES-SCLC) that has progressed after chemotherapy. • Nogapendekin alfa inbakicept-pmln (Anktiva), a first-in-class IL-15 receptor agonist, was approved in combination with Bacillus Calmette-Guérin (BCG) for non-muscle invasive bladder cancer (NMIBC) unresponsive to BCG alone. • The FDA expanded the use of CAR T-cell therapies, approving lisocabtagene maraleucel (Breyanzi) for relapsed or refractory follicular lymphoma and mantle cell lymphoma after multiple lines of systemic therapy. • Several targeted therapies received new indications, including selpercatinib (Retevmo) for RET-mutated thyroid cancers in children and adagrasib (Krazati) with cetuximab for KRASG12C-mutated colorectal cancers.

Global Dementia Clinical Trial Landscape Analyzed in New Report

  • A new report analyzes the global landscape of clinical trials for dementia, providing an overview of trial numbers and average enrollment across top countries.
  • The report covers clinical trials by region, country (G7 & E7), phase, trial status, endpoint status, and sponsor type, offering a comprehensive view of the research efforts.
  • Key companies involved in dementia therapeutics clinical trials are highlighted, along with prominent drugs in ongoing trials, aiding in competitive strategy development.
  • The analysis includes unaccomplished trials (terminated, suspended, and withdrawn) with reasons for incompletion, offering insights into trial success rates and potential challenges.

Cilta-cel Demonstrates Overall Survival Benefit in Relapsed/Refractory Multiple Myeloma

  • Cilta-cel, a CAR T-cell therapy, significantly improved overall survival (OS) compared to standard-of-care regimens in patients with relapsed/refractory multiple myeloma.
  • The CARTITUDE-4 trial showed a statistically significant and clinically meaningful OS benefit in lenalidomide-refractory patients who had received 1-3 prior lines of therapy.
  • Safety data from the trial were consistent with the established safety profile of cilta-cel, with no new safety signals identified.
  • These results support potential label updates and reinforce cilta-cel's role as an effective treatment option in earlier lines of multiple myeloma therapy.

A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma

NCT04181827Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 6/12/2020

NIH Launches Phase 1 Trial of Nasal COVID-19 Vaccine MPV/S-2P

  • The NIH has initiated a Phase 1 clinical trial for MPV/S-2P, a novel nasal COVID-19 vaccine, across three U.S. sites, aiming for improved protection against emerging variants.
  • MPV/S-2P utilizes a live-weakened murine pneumonia virus (MPV) to deliver a stabilized spike protein, potentially inducing a more robust mucosal immune response in the respiratory tract.
  • The trial will involve 60 healthy adults who have already received at least three mRNA COVID-19 vaccine doses, evaluating the vaccine's safety and immune response at varying dosages.
  • Researchers suggest nasal vaccines could offer advantages over traditional injections, including enhanced acceptance, easier storage, and potentially superior protection against the virus.

Safety and Immunogenicity Trial of MPV/S-2P SARS-CoV-2 Vaccine in Adults

NCT06441968Active, Not RecruitingPhase 1
National Institute of Allergy and Infectious Diseases (NIAID)
Posted 7/1/2024

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