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Clinical Trial News

EMA Backs Wegovy for Obesity-Related Heart Failure, Expanding Therapeutic Uses

  • The European Medicines Agency (EMA) has endorsed Novo Nordisk's Wegovy for treating heart failure in obese patients, marking its second supported use beyond weight loss.
  • Clinical trials demonstrated that Wegovy reduces heart failure-related symptoms and improves physical limitations and exercise function in patients with obesity-related HFpEF.
  • The EMA's decision reinforces Novo Nordisk's position on Wegovy's versatile health benefits, with a label update expected shortly to reflect these expanded uses.
  • Novo Nordisk plans to resubmit data to the FDA in 2025 regarding Wegovy's effectiveness in treating heart failure associated with obesity.

FDA Approves 420-mg Dosage of Trastuzumab-strf Biosimilar for HER2-Overexpressing Cancers

• The FDA has approved the 420-mg strength of trastuzumab-strf (Hercessi), a biosimilar to trastuzumab (Herceptin), for HER2-overexpressing cancers. • This approval expands the availability of trastuzumab-strf, which was initially approved in a 150-mg dose in April 2024. • Trastuzumab-strf is now approved for metastatic breast and gastric/gastroesophageal junction cancers that overexpress HER2. • The approval is based on data from pharmacokinetic similarity trials and a phase 3 trial demonstrating comparable safety and efficacy to the reference product.

Compare Efficacy, Safety and Immunogenicity of HLX02 and Herceptin in Previously Untreated HER2 +Overexpressing Metastatic Breast Cancer

NCT03084237CompletedPhase 3
Shanghai Henlius Biotech
Posted 11/1/2016

Elanco's Zenrelia (Ilunocitinib) Receives FDA Approval for Canine Dermatitis

  • Elanco's Zenrelia (ilunocitinib) has gained FDA approval as a once-daily oral treatment for pruritus associated with allergic dermatitis and atopic dermatitis in dogs.
  • A randomized, double-blind study demonstrated Zenrelia's noninferiority to a market-leading JAK inhibitor in relieving itch and skin lesions in dogs with atopic dermatitis.
  • Zenrelia is priced competitively, offering a potentially more affordable option for pet owners, with a consistent once-daily dosing regimen.
  • The drug's label includes a boxed warning regarding vaccine administration, advising discontinuation before and after vaccination due to potential risks.

FDA Cancels Advisory Committee Meeting for Applied Therapeutics' Govorestat, Boosting Approval Prospects

• The FDA has canceled the advisory committee meeting for govorestat, Applied Therapeutics' drug for classic galactosemia, signaling potential approval by the November 28 PDUFA date. • Analysts are optimistic about govorestat's approval and commercial potential, with Leerink Partners raising the probability of success (PoS) for both galactosemia and SORD deficiency. • Govorestat, a CNS penetrant aldose reductase inhibitor, targets rare neurological diseases by blocking glucose conversion to sorbitol, with peak sales estimated at $870 million for galactosemia alone. • Applied Therapeutics' stock price surged following the announcement, reflecting investor confidence in govorestat's prospects and the company's broader pipeline.

ATL001 in Patients With Advanced Unresectable or Metastatic NSCLC

NCT04032847TerminatedPhase 1
Achilles Therapeutics UK Limited
Posted 7/8/2019

A Safety, Pharmacokinetic and Clinical Activity Study of NUC-7738 in Patients With Advanced Solid Tumours and Lymphoma

NCT03829254RecruitingPhase 1
NuCana plc
Posted 6/17/2019

ATL001 in Patients With Metastatic or Recurrent Melanoma

NCT03997474TerminatedPhase 1
Achilles Therapeutics UK Limited
Posted 8/15/2019

A phase 2/3 study to evaluate efficacy and clinical benefit of AT-007 with Sorbitol Dehydrogenase (SORD) Deficiency

2024-518250-16-00Active, Not RecruitingPhase 2/3
Applied Therapeutics Inc.

Safety and Pharmacokinetics of AT-007 in Healthy Subjects and in Adult Subjects With Classic Galactosemia

NCT04117711CompletedPhase 1
Applied Therapeutics, Inc.
Posted 6/21/2019

A Study of EDG-7500 in Healthy Adults

NCT06011317CompletedPhase 1
Edgewise Therapeutics, Inc.
Posted 8/14/2023

A Study of EDG-7500 in Adults With Hypertrophic Cardiomyopathy (CIRRUS-HCM)

NCT06347159RecruitingPhase 2
Edgewise Therapeutics, Inc.
Posted 4/11/2024

FDA Issues Liver Injury Warning for Fezolinetant (Veozah) Used to Treat Menopausal Hot Flashes

  • The FDA has issued a warning regarding the use of fezolinetant (Veozah) due to rare but serious liver injury reported in a patient.
  • Fezolinetant received FDA approval in May 2023 as a nonhormonal treatment option for managing menopausal hot flashes.
  • Despite the warning, experts emphasize that liver injury is rare and reversible upon discontinuation, advising women not to be discouraged from using this effective therapy.

Bright Minds Biosciences Initiates Phase 2 Trial of BMB-101 for Drug-Resistant Epilepsy

  • Bright Minds Biosciences has commenced a Phase 2 clinical trial of BMB-101, targeting drug-resistant epilepsies, with detailed trial design to be discussed at an upcoming event.
  • The trial will explore BMB-101, a selective 5-HT2C receptor agonist, designed to exclusively target therapeutic pathways via G-protein signaling, potentially avoiding receptor desensitization.
  • Key Opinion Leaders (KOLs) in epilepsy research will provide insights into unmet needs and scientific innovations driving the BREAKTHROUGH clinical trial design on September 25th.
  • BMB-101 has demonstrated safety and target engagement in Phase 1 studies, showing a qEEG signature typical for anti-epileptic drugs and potential for improved cognition.

FDA Rejects Vanda Pharmaceuticals' Fanapt for Gastroparesis

  • The FDA has declined to approve Vanda Pharmaceuticals' supplemental New Drug Application (sNDA) for Fanapt (iloperidone) in treating gastroparesis, a stomach condition characterized by delayed gastric emptying.
  • This rejection marks a setback for Vanda, which sought to expand Fanapt's indication beyond its current approval for schizophrenia, addressing an unmet need in gastroparesis management.
  • The FDA's decision was based on a complete response letter (CRL), citing concerns that were not specified, but require further evaluation before potential approval.
  • Vanda Pharmaceuticals plans to review the FDA's feedback and determine the appropriate next steps, signaling continued commitment to finding solutions for gastroparesis patients.

Lutetium Lu 177 Vipivotide Tetraxetan Shows Promise in Prostate Cancer Treatment

• Lutetium Lu 177 vipivotide tetraxetan has emerged as a significant radioligand therapy for metastatic castration-resistant prostate cancer (mCRPC). • Studies indicate potential for earlier use of Lutetium Lu 177 vipivotide tetraxetan, before chemotherapy, offering improved tolerability and quality of life for patients. • Research explores combining Lutetium Lu 177 vipivotide tetraxetan with other therapies, such as androgen receptor pathway inhibitors, to enhance treatment synergy. • Ongoing trials are investigating novel targets and treatment strategies to address resistance and improve outcomes in advanced prostate cancer.

A Study of JNJ-69086420, an Actinium-225-Labeled Antibody Targeting Human Kallikrein-2 (hK2) for Advanced Prostate Cancer

NCT04644770RecruitingPhase 1
Janssen Research & Development, LLC
Posted 11/12/2020

Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer

NCT03511664CompletedPhase 3
Endocyte
Posted 5/29/2018

An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With SoC, Versus SoC Alone, in Adult Male Patients With mHSPC

NCT04720157Active, Not RecruitingPhase 3
Novartis Pharmaceuticals
Posted 6/9/2021

Apalutamide and Abiraterone Acetate in African American and Caucasian Men With Metastatic Castrate Resistant Prostate Cancer

NCT03098836CompletedPhase 2
Daniel George, MD
Posted 7/10/2017

Phase III Radium 223 mCRPC-PEACE III

NCT02194842Active, Not RecruitingPhase 3
European Organisation for Research and Treatment of Cancer - EORTC
Posted 10/1/2015

Darolutamide in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer

NCT02799602CompletedPhase 3
Bayer
Posted 11/30/2016

Study Evaluating mCRPC Treatment Using PSMA [Lu-177]-PNT2002 Therapy After Second-line Hormonal Treatment

NCT04647526Active, Not RecruitingPhase 3
POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company
Posted 2/25/2021

Enzalutamide With Lu PSMA-617 Versus Enzalutamide Alone in Men With Metastatic Castration-resistant Prostate Cancer

NCT04419402Active, Not RecruitingPhase 2
Australian and New Zealand Urogenital and Prostate Cancer Trials Group
Posted 8/17/2020

A Phase III Study for Patients With Metastatic Hormone-naïve Prostate Cancer

NCT01957436Active, Not RecruitingPhase 3
UNICANCER
Posted 11/13/2013

An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC.

NCT05939414RecruitingPhase 3
Novartis Pharmaceuticals
Posted 3/12/2024

177Lu-PSMA-617 vs. Androgen Receptor-directed Therapy in the Treatment of Progressive Metastatic Castrate Resistant Prostate Cancer

NCT04689828Active, Not RecruitingPhase 3
Novartis Pharmaceuticals
Posted 6/15/2021

EMA Approves Variation for Imvanex, Expanding Protection Against Monkeypox

  • The European Medicines Agency (EMA) has approved a variation to the marketing authorization for Imvanex.
  • This variation expands the use of the vaccine to include protection against monkeypox, in addition to smallpox.
  • Imvanex, manufactured using Modified Vaccinia Ankara (MVA) virus, offers a crucial preventative measure.
  • The approval marks a significant step in combating the spread of monkeypox within Europe.

Summit Therapeutics' Phase III Trial Bests Merck's Keytruda in Lung Cancer

  • Summit Therapeutics' SMT-i100 demonstrated superior efficacy compared to Keytruda in a Phase III trial for non-small cell lung cancer (NSCLC).
  • The study highlighted SMT-i100's potential as a novel therapeutic option, particularly in patients with PD-L1 negative or low expressing tumors.
  • These results suggest a significant advancement in lung cancer treatment, offering hope for improved outcomes in a challenging patient population.

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