OLX301A / OliX Pharma, Thea Laboratories - LARVOL DELTA

Daeshin Securities announced on June 23rd that OliX Pharmaceuticals (KOSDAQ: 226950) is broadening its therapeutic ambitions… (KBI Intelligence) - "Phase 1 trials have concluded, and OliX expects to receive the clinical study report (CSR) between August and October. Phase 2 enrolment and the associated milestone payments from Eli Lilly are then anticipated to follow...OLX501A, has produced encouraging early results. In a single-dose primate study, it reduced target messenger RNA by as much as 84%. More strikingly, when combined with tirzepatide (sold as Zepbound) at just one-tenth of the standard high dose, the drug maintained its fat-reduction effect while also blunting the weight rebound typically seen after treatment is stopped...Full data are scheduled to be disclosed at an R&D day on July 14th. The company is seeking to license the asset to a partner before initiating clinical trials....OliX is advancing a treatment for age-related macular degeneration, OLX301A...company plans to file an investigational new drug (IND) application for a multi-country phase 2 trial in the second half of this year..."

IND • New P2 trial • P1 data • Preclinical • Trial status • Age-related Macular Degeneration • Metabolic Dysfunction-Associated Steatohepatitis • Obesity

Cell-penetrating asymmetric siRNA targeting MyD88 suppresses inflammasome-driven ocular degeneration and angiogenesis. (PubMed, Mol Ther) - "Topical administration further ameliorated corneal epithelial injury and inflammatory cytokine expression in a benzalkonium chloride-induced DED model. A phase 1 clinical trial of intravitreal OLX10212 in patients with neovascular AMD is ongoing, and phase 2 studies are planned."

Journal • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Dry Eye Disease • Inflammation • Macular Degeneration • Ocular Inflammation • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration • MYD88 • NLRP3

Results of Phase 1 Trial of Intravitreal siRNA Targeting MyD88 (OLX10212) in Previously Treated Neovascular AMD Patients. (ARVO 2026) - P1 | "In Part B, 2/6 patients (33%) gained >/= 5 letters at wk 10. Conclusions OLX10212 was safe and well-tolerated in previously treated wet AMD, showing positive visual function results (a sign of safety adn potentially efficacy) supporting further clinical development."

Clinical • P1 data • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration • MYD88

Evaluation of OLX10212 in Patients With Neovascular Age-related Macular Degeneration (clinicaltrials.gov) - P1 | N=21 | Completed | Sponsor: Olix Pharmaceuticals, Inc. | Recruiting ➔ Completed | N=42 ➔ 21 | Trial completion date: Dec 2024 ➔ Nov 2025

Enrollment change • Trial completion • Trial completion date • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Gene Therapy for Non-Hereditary Retinal Disease: Age-Related Macular Degeneration, Diabetic Retinopathy, and Beyond. (PubMed, Genes (Basel)) - "This manuscript reviews ongoing gene therapy clinical trials for these disorders, including ABBV-RGX-314, ixoberogene soroparvovec (ixo-vec), and 4D-150. ABBV-RGX-314 utilizes an adeno-associated virus (AAV) vector to deliver a transgene encoding a ranibizumab-like anti-VEGF antibody fragment, demonstrating promising results in Phase 1/2a and ongoing Phase 2b/3 trials...Other therapies reviewed include EXG102-031, FT-003, KH631, OLX10212, JNJ-1887, 4D-175, and OCU410. These therapies offer potential advantages of reduced treatment frequency and enhanced safety profiles, representing a paradigm shift in management towards durable and efficacious cellular-based biofactories. These advancements in gene therapy hold promise for improving outcomes in AMD and addressing the complex challenges of DME and DR, providing new avenues for the treatment of diabetic eye diseases."

Gene therapy • Journal • Review • Age-related Macular Degeneration • Diabetic Macular Edema • Diabetic Retinopathy • Gene Therapies • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration • VEGFC