Clinical Trial News

Bayer's Kerendia and Nubeqa Drive Strong Pharmaceutical Growth, Q2 Sales Hit €11.1 Billion

10 months ago

Bayer reports robust Q2 performance with pharmaceutical sales reaching €4.61 billion, driven by 73% growth in Kerendia and 90% growth in Nubeqa.
Under new CEO Bill Anderson's leadership, Bayer advances cost-saving initiatives, achieving 3,200 job reductions and targeting €2 billion in savings by 2026.
Despite generic competition impacting Xarelto sales, Bayer upgrades its pharmaceutical division forecast to 0%-3% growth for the year, joining other European pharma companies in positive outlook revisions.

10 months ago

George Medicines has filed an NDA with the FDA for GMRx2, a triple combination single pill for hypertension, based on positive Phase III trial results.
GMRx2 combines telmisartan, amlodipine, and indapamide in low doses, demonstrating efficacy and safety compared to dual therapy and placebo.
The therapy targets the large uncontrolled hypertension population in the US, where only a quarter of affected adults have their condition managed.
GMRx2 offers a novel approach to hypertension management with potential for improved blood pressure control, tolerability, and patient adherence.

10 months ago

Abivax's Phase 3 ABTECT trial, evaluating obefazimod for ulcerative colitis, has surpassed 600 patients enrolled, marking a significant milestone.
The trial is on track to achieve full enrollment in early Q1 2025, reinforcing the company's timeline for this pivotal study.
Baseline characteristics of participants align with observations from the Phase 2b trial, suggesting consistency in patient population.
Obefazimod, an oral small molecule, aims to enhance miR-124 expression and is also planned for a Phase 2b trial in Crohn's disease.

10 months ago

Shanton Pharma has completed enrollment of 87 patients across 21 US sites for its Phase 2b study of SAP-001, a potential breakthrough treatment for refractory and tophaceous gout.
The six-month clinical trial targets patients who don't respond to maximum tolerable doses of conventional Xanthine Oxidase Inhibitors, with topline data expected in Q1 2025.
SAP-001, designed for once-daily oral administration, demonstrated promising efficacy and safety in earlier Phase 1 and 2a studies, positioning it as a potential best-in-class treatment for severe gout.

10 months ago

Turn Therapeutics' GX-03 demonstrated significant inhibition of IL-31, IL-36α, and IL-36γ in a preclinical eczema model, suggesting potential efficacy in atopic dermatitis.
The study showed a 67.7% reduction in IL-31 levels compared to placebo (p < 0.000001), highlighting GX-03's ability to modulate key cytokines involved in eczema pathogenesis.
GX-03 pretreatment led to a significant reduction in ISGA score, indicating a shift from mild-moderate eczema to clear or almost clear skin compared to placebo.
With a well-established safety profile, Turn Therapeutics plans to advance GX-03, a non-steroid, non-injectable asset, into clinical trials for atopic dermatitis.

10 months ago

University of Sheffield researchers have developed a new nanoparticle-based immunotherapy that significantly delays resistance to androgen deprivation therapy (ADT) in prostate cancer patients.
The innovative approach targets macrophages around blood vessels in prostate tumors, causing them to release interferon-beta which activates T cells to attack cancer cells.
This breakthrough could potentially extend the effectiveness of hormone therapy for thousands of men, addressing a critical gap as traditional immunotherapies have historically shown limited success in prostate cancer.

10 months ago

Longeveron's Lomecel-B, an allogeneic medicinal signaling cell therapy, has shown promise in Phase IIa trials by slowing disease progression in Alzheimer's patients.
Lexeo Therapeutics is developing gene therapies targeting APOE alleles, with LX1001 in Phase I/II trials, focusing on the 40-50% of Alzheimer's patients with APOE4.
Early-stage companies like Regeneration Biomedical are also exploring stem cell therapies, showing cognitive improvements in late-stage Alzheimer's patients in Phase I trials.
Cell and gene therapies offer a potential advantage over existing treatments by potentially reducing adverse events, though scalability and trial complexities remain challenges.

10 months ago

The FDA has approved Ocugen's expanded access program (EAP) for OCU400, a modifier gene therapy, for adults with retinitis pigmentosa (RP).
The EAP will allow eligible RP patients with unmet medical needs to access OCU400 outside of the ongoing Phase 3 liMeliGhT clinical trial.
OCU400 targets multiple gene mutations associated with RP by resetting dysfunctional gene networks in retinal cells to restore cellular homeostasis.
Ocugen anticipates potential BLA and MAA approval for OCU400 in 2026, with Phase 3 trial enrollment expanded to include diverse RP gene mutations.

NCT06388200RecruitingPhase 3

Ocugen

Posted 6/18/2024

10 months ago

Innovent and SanegeneBio have dosed the first participant in a Phase 1 clinical trial of IBI3016, an siRNA drug for hypertension.
IBI3016 targets angiotensinogen (AGT) to reduce blood pressure, showing promise in preclinical studies with sustained efficacy and safety.
The Phase 1 trial will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of IBI3016 in healthy volunteers and patients with mild hypertension.
This collaboration leverages SanegeneBio's siRNA technology and Innovent's clinical expertise to address the unmet need for effective hypertension treatments.

NCT06501586RecruitingPhase 1

Suzhou Sanegene Bio Inc.

Posted 7/31/2024

10 months ago

The FDA's Genetic Metabolic Diseases Advisory Committee voted favorably (11-5) on the effectiveness of arimoclomol for treating Niemann-Pick Disease Type C (NPC).
The committee's decision was based on pivotal trial data, long-term open-label extension study results, and expanded access programs, indicating arimoclomol's clinical benefit.
Arimoclomol, developed by Zevra Therapeutics, has a PDUFA action date of September 21, 2024, for potential FDA approval as a treatment for NPC.
NPC is an ultra-rare, progressive, neurodegenerative lysosomal storage disorder, and arimoclomol has received multiple designations, including Orphan Drug and Breakthrough Therapy designations.

ZevraDenmark