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Clinical Trial News

Acelyrin's Izokibep Fails to Meet Primary Endpoint in Phase 2b/3 Psoriasis Trial, Stock Plummets

• Acelyrin's stock price plummeted after its investigational drug, izokibep, failed to achieve the primary endpoint in a Phase 2b/3 clinical trial for moderate-to-severe psoriasis. • The trial results were described as "painfully disappointing" by analysts, leading to a significant reduction in the company's price target by Jefferies. • Despite the setback, all five analysts covering Acelyrin maintain a "strong buy" rating, though the consensus price target is now significantly higher than the current stock price. • Izokibep, a potentially best-in-class IL-17A inhibitor, showed promise in previous trials, but this outcome raises concerns about its efficacy in psoriasis.

Acelyrin's Izokibep Fails to Meet Primary Endpoint in Phase 2b/3 Hidradenitis Suppurativa Trial

• Acelyrin's izokibep, an IL-17A inhibitor, did not meet the primary endpoint of HiSCR75 in a Phase 2b/3 trial for hidradenitis suppurativa (HS). • The HiSCR75 response rate at week 16 was 39% for izokibep (160 mg weekly) and 29% for placebo, failing to demonstrate a statistically significant treatment effect (p=0.3278). • Despite the primary endpoint failure, post-hoc analyses showed stronger efficacy signals related to HiSCR100, indicating potential for complete disease resolution. • Acelyrin is continuing to investigate izokibep in an ongoing Phase 3 trial for HS, based on observed HiSCR100 results and previous psoriatic arthritis data.

Hidradenitis Suppurativa Study of Izokibep

NCT05905783TerminatedPhase 3
ACELYRIN Inc.
Posted 6/22/2023

Hidradenitis Suppurativa Phase 2b Pivotal Study of Izokibep

NCT05355805CompletedPhase 2
ACELYRIN Inc.
Posted 5/5/2022

SKYRIZI® (risankizumab) Demonstrates Superiority Over STELARA® (ustekinumab) in Crohn's Disease Head-to-Head Trial

  • Risankizumab met the primary endpoint of non-inferiority for clinical remission at week 24 compared to ustekinumab in Crohn's disease patients who failed anti-TNF therapy.
  • The study also met the primary endpoint of superiority in endoscopic remission at week 48 with risankizumab compared to ustekinumab.
  • All secondary endpoints achieved statistical significance for superiority with risankizumab versus ustekinumab, reinforcing SKYRIZI's effectiveness.
  • The safety profile of risankizumab was consistent with previous studies, with no new safety risks identified in the SEQUENCE trial.

Study Comparing Intravenous (IV)/Subcutaneous (SC) Risankizumab to IV/SC Ustekinumab to Assess Change in Crohn's Disease Activity Index (CDAI) in Adult Participants With Moderate to Severe Crohn's Disease (CD)

NCT04524611Active, Not RecruitingPhase 3
AbbVie
Posted 9/30/2020

A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(Ies)

NCT03671148Active, Not RecruitingPhase 3
AbbVie
Posted 3/7/2019

A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis

NCT03398148CompletedPhase 2
AbbVie
Posted 3/7/2018

Acelyrin's Izokibep Fails to Meet Primary Endpoint in Phase 2b Hidradenitis Suppurativa Trial

• Acelyrin's izokibep did not meet the primary endpoint of HiSCR75 at week 16 in a Phase 2b trial for moderate-to-severe Hidradenitis Suppurativa (HS). • The trial showed early HiSCR100 responses and a dose-effect favoring 160mg weekly dosing, with no safety or tolerability limitations observed. • Despite the setback, analysts remain bullish about Acelyrin's stock, maintaining a consensus rating of Strong Buy with unanimous Buys. • Acelyrin plans to continue evaluating 160 mg QW dosing in HS and other indications, including uveitis and Psoriatic Arthritis (PsA).

FDA Approves Updated COVID-19 Vaccines from Pfizer and Moderna Targeting XBB.1.5 Omicron Variant

  • The FDA has approved updated COVID-19 vaccines from Pfizer and Moderna, targeting the Omicron subvariant XBB.1.5, for individuals 12 years and older, with emergency use authorization for children aged 6 months to 11 years.
  • These updated vaccines are poised for imminent distribution across the U.S. following a CDC advisory panel recommendation, amidst rising COVID-19 hospitalizations, offering reassurance as cases increase.
  • While the updated vaccines do not specifically target currently dominant variants like EG.5 (Eris), manufacturers assert they will still provide protection against these strains as the school year commences and temperatures drop.
  • Health officials are encouraging individuals to receive the updated COVID-19 vaccine alongside their annual flu shot, as hospitalizations have increased for seven consecutive weeks, rising over 15% in late August.

Advances in Alzheimer's Disease Treatment: A Focus on Disease-Modifying Therapies

This article explores the latest advancements in Alzheimer's Disease (AD) treatment, emphasizing disease-modifying therapies (DMTs) and non-pharmacological interventions. It highlights the challenges in AD drug development, the potential of monoclonal antibodies (mAbs) targeting amyloid-beta (Aβ) and tau proteins, and the importance of early detection through biomarkers. The article also discusses ongoing clinical trials, the role of small molecules, and the emerging field of stem cell therapy in AD treatment.

GV1001 Subcutaneous for the Treatment of Moderate to Severe Alzheimer's Disease(AD)

NCT05303701Not Yet RecruitingPhase 3
Samsung Pharmaceutical Co., Ltd.
Posted 5/1/2025

A Research Study Investigating Semaglutide in People With Early Alzheimer's Disease (EVOKE Plus)

NCT04777409Active, Not RecruitingPhase 3
Novo Nordisk A/S
Posted 5/18/2021

Masitinib in Patients With Mild to Moderate Alzheimer's Disease

NCT01872598CompletedPhase 3
AB Science
Posted 1/1/2012

Study of AGB101 in Mild Cognitive Impairment Due to Alzheimer's Disease

NCT03486938CompletedPhase 2
AgeneBio
Posted 12/13/2018

Masitinib in Patients With Mild to Moderate Alzheimer's Disease

NCT05564169Not Yet RecruitingPhase 3
AB Science
Posted 1/1/2024

A Study to Verify the Clinical Benefit of Aducanumab in Participants With Early Alzheimer's Disease

NCT05310071TerminatedPhase 3
Biogen
Posted 6/2/2022

Insulin-Sensitizing Anti-Inflammatory Small Molecule for Investigative Treatment of Dementia

NCT05227820CompletedPhase 2
Neurological Associates of West Los Angeles
Posted 1/19/2022

AHEAD 3-45 Study: A Study to Evaluate Efficacy and Safety of Treatment With Lecanemab in Participants With Preclinical Alzheimer's Disease and Elevated Amyloid and Also in Participants With Early Preclinical Alzheimer's Disease and Intermediate Amyloid

NCT04468659Active, Not RecruitingPhase 3
Eisai Inc.
Posted 7/14/2020

A Study to Evaluate the Safety, Tolerability, and Efficacy of Long-Term Gantenerumab Administration in Participants With Alzheimer's Disease (AD)

NCT04374253TerminatedPhase 3
Hoffmann-La Roche
Posted 1/26/2021

Effect of Hydralazine on Alzheimer's Disease

NCT04842552Unknown StatusPhase 3
Shahid Sadoughi University of Medical Sciences and Health Services
Posted 8/2/2021

Preventing Alzheimer's With Cognitive Training

NCT03848312RecruitingPhase 3
University of South Florida
Posted 2/19/2019

A Study to Evaluate the Efficacy and Safety of Gantenerumab in Participants at Risk for or at the Earliest Stages of Alzheimer's Disease (AD)

NCT05256134TerminatedPhase 3
Hoffmann-La Roche
Posted 4/19/2022

Allogeneic Human Mesenchymal Stem Cells for Alzheimer's Disease

NCT02833792RecruitingPhase 2
Stemedica Cell Technologies, Inc.
Posted 6/1/2016

Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Individuals at Risk for or With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation. Master Protocol DIAN-TU-001

NCT01760005RecruitingPhase 2
Washington University School of Medicine
Posted 12/1/2012

Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Individuals With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation (DIAN-TU)

NCT05269394Active, Not RecruitingPhase 2
Washington University School of Medicine
Posted 12/22/2021

A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5)

NCT05508789RecruitingPhase 3
Eli Lilly and Company
Posted 10/10/2022

A Study of Potential Disease Modifying Treatments in Individuals at Risk for or With a Type of Early Onset AD Caused by a Genetic Mutation

NCT05552157RecruitingPhase 2
Washington University School of Medicine
Posted 11/22/2024

Open-label Extension for Phase 3 Clinical Trials of Simufilam

NCT05575076TerminatedPhase 3
Cassava Sciences, Inc.
Posted 11/7/2022

A Phase 3 Study of NE3107 in Probable Alzheimer's Disease

NCT04669028CompletedPhase 3
BioVie Inc.
Posted 8/5/2021

Piromelatine 20 mg in Participants With Mild Dementia Due to Alzheimer's Disease

NCT05267535Active, Not RecruitingPhase 2
Neurim Pharmaceuticals Ltd.
Posted 5/12/2022

A Study of Remternetug (LY3372993) in Participants With Alzheimer's Disease (TRAILRUNNER-ALZ 1)

NCT05463731Active, Not RecruitingPhase 3
Eli Lilly and Company
Posted 8/1/2022

A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease

NCT03887455Active, Not RecruitingPhase 3
Eisai Inc.
Posted 3/27/2019

A Pivotal Study of LIPUS-Brain in Patients With Early Alzheimer's Disease

NCT05983575Active, Not RecruitingPhase 3
Sound Wave Innovation CO., LTD.
Posted 10/31/2023

Safety and Efficacy of TRx0237 in Subjects With Alzheimer's Disease Followed by Open-Label Treatment

NCT03446001CompletedPhase 3
TauRx Therapeutics Ltd
Posted 1/10/2018

A Research Study Investigating Semaglutide in People With Early Alzheimer's Disease (EVOKE)

NCT04777396Active, Not RecruitingPhase 3
Novo Nordisk A/S
Posted 5/18/2021

Precision Medicine Approach for Early Dementia & Mild Cognitive Impairment

NCT05894954Active, Not RecruitingPhase 3
Alzheimer's Prevention and Reversal Project, Inc.
Posted 7/31/2023

ATH-1017 for Treatment of Mild to Moderate Alzheimer's Disease

NCT04488419CompletedPhase 2
Athira Pharma
Posted 9/28/2020

OLE of Phase 2b/3 Study ANAVEX2-73-AD-004

NCT04314934CompletedPhase 2
Anavex Life Sciences Corp.
Posted 10/10/2019

Clinical Trial of Solanezumab for Older Individuals Who May be at Risk for Memory Loss

NCT02008357CompletedPhase 3
Eli Lilly and Company
Posted 2/28/2014

Simufilam 100 mg for Mild-to-Moderate Alzheimer's Disease

NCT04994483CompletedPhase 3
Cassava Sciences, Inc.
Posted 11/3/2021

Simufilam 50 mg or 100 mg for Mild-to-Moderate Alzheimer's Disease

NCT05026177TerminatedPhase 3
Cassava Sciences, Inc.
Posted 11/18/2021

Brain Amyloid and Vascular Effects of Eicosapentaenoic Acid

NCT02719327CompletedPhase 2
VA Office of Research and Development
Posted 6/8/2017

A Study to Evaluate Safety and Tolerability of Aducanumab in Participants With Alzheimer's Disease Who Had Previously Participated in the Aducanumab Studies 221AD103, 221AD301, 221AD302 and 221AD205

NCT04241068TerminatedPhase 3
Biogen
Posted 3/2/2020

An Efficacy and Safety Study of ALZ-801 in APOE4/4 Early AD Subjects

NCT04770220CompletedPhase 3
Alzheon Inc.
Posted 5/19/2021

Evaluating the Efficacy and Safety of Nilotinib BE in Subjects With Early Alzheimer's Disease

NCT05143528Not Yet RecruitingPhase 3
KeifeRx, LLC
Posted 2/1/2022

Lomecel-B Effects on Alzheimer's Disease

NCT05233774CompletedPhase 2
Longeveron Inc.
Posted 12/28/2021

A Study to Evaluate the Safety and Tolerability of Long-term Administration of Gantenerumab in Participants With Alzheimer's Disease (AD)

NCT04339413TerminatedPhase 3
Hoffmann-La Roche
Posted 5/22/2020

A Donanemab (LY3002813) Study in Participants With Preclinical Alzheimer's Disease (TRAILBLAZER-ALZ 3)

NCT05026866RecruitingPhase 3
Eli Lilly and Company
Posted 8/27/2021

Study to Evaluate the Safety and Efficacy of AstroStem in Treatment of Alzheimer's Disease

NCT04482413Not Yet RecruitingPhase 2
Nature Cell Co. Ltd.
Posted 2/1/2023

Vir Biotechnology Faces Setbacks in HBV and Influenza Trials, Stock Downgraded

• Vir Biotechnology's stock declined 54% year-to-date due to lackluster results from influenza A and hepatitis B (HBV) trials, leading to a downgrade by Bank of America. • Upcoming results in Q4 2023 for the triple combination treatment of Vir-2218, Vir-3434, and PEG-INF in HBV are crucial, requiring functional cure rates over 40-50% for commercial viability. • Key data that could potentially drive a re-rating of Vir shares is not expected until Q2 2024, including functional cure data from the triple combo with 24 weeks of treatment. • Despite recent challenges, Vir continues to develop a next-generation flu antibody and has multiple HBV trial results expected, offering potential future catalysts for stock improvement.

Ariceum Therapeutics Doses First Patient in Phase Ib Study for Small Cell Lung Cancer Treatment

Ariceum Therapeutics has dosed the first patient in its Phase Ib study using satoreotide, a first-in-class targeted radiopharmaceutical drug, for the treatment of extensive stage small cell lung cancer. The study aims to evaluate the safety and tolerability of the theranostic pair of 68Ga-Satoreotide Trizoxetan and 177Lu-satoreotide tetraxetan, with the goal of establishing a recommended Phase 2 dose.

EMA Reviews Givinostat for Duchenne Muscular Dystrophy

  • The European Medicines Agency (EMA) is reviewing Italfarmaco's application to market givinostat for Duchenne muscular dystrophy (DMD).
  • The application is based on the Phase 3 EPIDYS trial, which demonstrated that givinostat significantly slowed motor function decline in boys with DMD.
  • Givinostat, an HDAC inhibitor, aims to improve muscle mass and repair by blocking histone deacetylases, which are overly active in DMD patients.
  • The FDA has also granted priority review to givinostat, potentially expediting its approval in the United States.

Clinical Study to Evaluate the Efficacy and Safety of Givinostat in Ambulant Patients With Duchenne Muscular Dystrophy

NCT02851797CompletedPhase 3
Italfarmaco
Posted 6/6/2017

Spectral Medical Closes C$6.1 Million Financing to Advance Tigris Septic Shock Trial

  • Spectral Medical has closed a C$6.1 million bought deal private placement of convertible notes to fund its Tigris study for endotoxic septic shock.
  • The financing included participation from strategic investors Baxter International Inc. and Pinnacle Island LP, demonstrating confidence in Spectral's strategy.
  • The Tigris study, evaluating the PMX product, has enrolled 72 patients and is on track to reach 90 patients by the end of 2023.
  • Proceeds will support the Phase III registration trial for PMX and general corporate purposes, as Spectral seeks FDA approval for its septic shock treatment.

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