MedPath

Clinical Trial News

Leo Pharma's Delgocitinib Filing Accepted in the US, Expanding JAK Inhibitor Market

  • Leo Pharma's delgocitinib, a JAK inhibitor, has been accepted for filing in the US, marking a significant step towards entering the American market.
  • The drug has already received approval in Europe, positioning it as a key growth driver for the Danish dermatology company.
  • Delgocitinib aims to address unmet needs in dermatology by offering a novel treatment option for relevant skin conditions.
  • This US filing represents Leo Pharma's strategic expansion and commitment to providing innovative therapies in major pharmaceutical markets.

ReAlta Life Sciences Doses First Patient in Phase 2 aGvHD Trial with RLS-0071

  • ReAlta Life Sciences has initiated a Phase 2 clinical trial of RLS-0071 for steroid-refractory acute graft-versus-host disease (aGvHD).
  • The open-label, dose-escalation study will evaluate the safety, tolerability, pharmacokinetics, and efficacy of RLS-0071 in hospitalized patients.
  • RLS-0071, an investigational EPICC peptide, modulates both complement and innate inflammatory pathways, offering a novel dual-targeting mechanism.
  • The FDA has granted Orphan Drug and Fast Track designations to RLS-0071 for the treatment of steroid-refractory aGvHD, highlighting its potential.

Safety, PK and PD Relationships of RLS-0071 in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease

NCT06175065Active, Not RecruitingPhase 2
ReAlta Life Sciences, Inc.
Posted 1/25/2024

Safety, PK, PD, Dosing, and Efficacy of RLS-0071for the Treatment of Hospitalized Patients with Steroid-Refractory Acute Graft-versus-Host Disease

NCT06343792RecruitingPhase 2
ReAlta Life Sciences, Inc.
Posted 8/31/2024

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of RLS-0071 in Newborns With Moderate or Severe Hypoxic-Ischemic Encephalopathy Undergoing Therapeutic Hypothermia

NCT05778188RecruitingPhase 2
ReAlta Life Sciences, Inc.
Posted 7/27/2023

LP-184 Receives FDA Rare Pediatric Disease Designations for Three Cancer Types

  • Lantern Pharma's LP-184 has been granted Rare Pediatric Disease Designations (RPDD) by the FDA for malignant rhabdoid tumors, rhabdomyosarcoma, and hepatoblastoma.
  • LP-184 now holds a total of four RPDDs, including a previous designation for atypical teratoid rhabdoid tumors (ATRT), highlighting its potential in treating rare childhood cancers.
  • Preclinical data demonstrated tumor regression and prolonged event-free survival in models developed under the National Cancer Institute's Pediatric Preclinical Testing Program.
  • The RPDD may qualify Lantern Pharma for a Priority Review Voucher upon FDA approval, potentially expediting future drug application reviews.

Study of LP-184 in Patients with Advanced Solid Tumors

NCT05933265RecruitingPhase 1
Lantern Pharma Inc.
Posted 6/9/2023

Mixed Results for Cancer and Neurological Drugs, Regulatory Scrutiny Intensifies for PBMs

  • Daiichi Sankyo and AstraZeneca's Dato-DXd failed to improve overall survival in the TROPION-Breast01 trial, despite earlier reports of delaying tumor progression in certain breast cancers.
  • Black Diamond Therapeutics reported a 42% tumor response rate for BDTX-1535 in EGFR-mutated non-small cell lung cancer resistant to Tagrisso.
  • Biohaven's troriluzole met its primary endpoint in a Phase 3 trial for spinocerebellar ataxia, with plans for FDA submission after a previous rejection.

Bonafide Health Launches Thermella, a Hormone-Free NK3R Antagonist for Menopause

  • Bonafide Health has launched Thermella, a hormone-free, prescription-free NK3R antagonist, to relieve hot flashes and night sweats associated with menopause.
  • Clinical trials showed that over 90% of participants experienced improvement in moderate to severe hot flashes within 12 weeks of using Thermella.
  • Thermella is formulated with curcumin extract, green tea extract, and spirulina extract, targeting the neurokinin B (NKB) pathway to rebalance the body's thermoregulatory center.
  • Studies suggest a favorable safety profile, with no serious adverse events reported and no estrogenic effects observed on breast cancer cell lines.

Herbal Nutraceutical Supplementation on Vasomotor Symptoms in Menopausal Women

NCT05813067CompletedNot Applicable
Bonafide Health
Posted 12/27/2022

Kazia Therapeutics' EVT801 Shows Promise in Ovarian Cancer Trial

  • Kazia Therapeutics presented Phase 1 data for EVT801, a VEGFR3 inhibitor, at the Ovarian Cancer Research Symposium, showcasing its potential in treating advanced ovarian cancer.
  • The Phase 1 trial of EVT801 met its primary objectives, establishing a maximum tolerated dose of 500mg BID and identifying 400mg BID as the recommended Phase 2 dose.
  • In heavily pretreated ovarian cancer patients, 46% achieved stable disease for at least three cycles, with one patient experiencing a partial response after two cycles of EVT801 therapy.
  • EVT801 was well-tolerated across all doses, with most toxicities being mild to moderate and transient, suggesting a favorable safety profile for further clinical development.

Vistagen Initiates Phase 3 Trial of Fasedienol for Acute Social Anxiety Disorder Treatment

  • Vistagen has commenced the PALISADE-4 Phase 3 trial to assess fasedienol nasal spray for acute treatment of social anxiety disorder (SAD).
  • The trial will evaluate fasedienol's efficacy, safety, and tolerability in adults with SAD during induced anxiety in a clinical setting.
  • Fasedienol, a neuroactive pherine, offers a novel non-systemic approach, potentially transforming acute SAD treatment for over 30 million Americans.
  • The FDA has granted Fast Track designation for fasedienol, highlighting the unmet need for acute SAD treatments.

Immusoft's Engineered B Cell Therapy Shows Promise in Phase 1 MPS I Trial

  • Immusoft announced positive Phase 1 results for ISP-001, an engineered B cell therapy, in a patient with mucopolysaccharidosis type I (MPS I).
  • The trial, supported by an $8 million CIRM award, demonstrated pharmacodynamic and functional improvements nine months post-dosing with a single ISP-001 administration.
  • The therapy was well-tolerated, with no adverse events reported as of September 19, 2024, and did not require preconditioning regimens.
  • Initial data, to be presented on October 14, 2024, indicate potential improvements in quality of life, activities of daily living, and pain reduction associated with MPS I.

ISP-001: Sleeping Beauty Transposon-Engineered B Cells for MPS I

NCT05682144RecruitingPhase 1
Immusoft of CA, Inc.
Posted 4/12/2023

Rivus Pharmaceuticals' HU6 Shows Muscle-Sparing Weight Loss in HFpEF Trial

  • Rivus Pharmaceuticals' HU6 demonstrated statistically significant reductions in fat mass and visceral fat in obese patients with heart failure with preserved ejection fraction (HFpEF).
  • The Phase IIa HuMAIN trial showed that HU6 preserved lean body mass, a crucial benefit for HFpEF patients where muscle loss is linked to increased mortality.
  • HU6 also showed promise in improving systolic and diastolic blood pressure and markers of cardiovascular disease, according to trial data presented at HFSA 2024.
  • Rivus plans to engage with health authorities in 2025 to discuss a Phase 3 study of HU6 in obesity-related HFpEF, aiming to address the unmet need for targeted therapies.

Exploratory Ph 2A, Double-Blind, Placebo-Controlled Dose Escalation Study of Safety, Tolerability, PD, & PK of HU6 for Subjects With Obese HFpEF

NCT05284617CompletedPhase 2
Rivus Pharmaceuticals, Inc.
Posted 10/30/2022

Theriva Biologics Completes Enrollment in Phase 2b VIRAGE Trial of VCN-01 for Metastatic Pancreatic Cancer

  • Theriva Biologics has achieved target enrollment of 92 patients in its Phase 2b VIRAGE trial for metastatic pancreatic ductal adenocarcinoma (PDAC).
  • The VIRAGE trial evaluates VCN-01, an oncolytic adenovirus, in combination with gemcitabine/nab-paclitaxel as a first-line therapy for PDAC.
  • VCN-01 has received Orphan Drug and Fast Track designations from the FDA for the treatment of PDAC, highlighting its potential impact.
  • The company is planning regulatory discussions to determine the next steps for VCN-01's clinical development, including a possible interim data analysis.

Study to evaluate the impact of VCN-01 on the overall survival of patients with advanced pancreatic cancer treated with standard therapy.

2024-511290-30-00CompletedPhase 2
Theriva Biologics S.L., Theriva Biologics S.L.

Trending News

1

FDA Approves Streamlined Access for Bristol Myers Squibb CAR T Cell Therapies

2 days ago
2

UCB's Fenfluramine Achieves Positive Phase 3 Results in Ultra-Rare CDKL5 Deficiency Disorder

2 days ago
3

ProFound Therapeutics Partners with Novartis in $775M Cardiovascular Drug Discovery Deal

3 days ago
4

Lipocine Initiates Phase 3 Trial for Oral Brexanolone in Postpartum Depression

3 days ago
5

China Approves First Once-Daily Nebulized LAMA for COPD, Triggering $7.5M Milestone for Theravance

3 days ago
6

FDA Approves Gamifant as First Treatment for Macrophage Activation Syndrome in Still's Disease

2 days ago
7

Cellarity Initiates Phase 1 Trial of CLY-124, First-in-Class Oral Therapy for Sickle Cell Disease

3 days ago
8

Portable Gene Therapy Device Could Revolutionize On-Demand Personalized Medicine for Rare Diseases

3 days ago
9

Incyte Names Bill Meury as New CEO, Replacing 11-Year Veteran Hervé Hoppenot

3 days ago
10

First European Patient Receives Breakthrough Treatment for Ultra-Rare APDS Immune Disorder

2 days ago
Subscribe Icon

Daily Pharma Insights

Get curated, high-impact pharmaceutical news delivered to your inbox every morning.

  • Critical clinical trial updates & results
  • Regulatory approvals & strategic partnerships
  • Market access decisions & commercial developments
© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy