Home » Drug & Device Pipeline News - Feb. 5, 2024
Drug & Device Pipeline News - Feb. 5, 2024
February 5, 2024
This week’s Pipeline features a phase 1 trial approval for Stargardt disease, a phase 1 trial start for rheumatoid arthritis and an FDA device approval for paroxysmal atrial fibrillation.
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| Trials Authorized | |||
| Vanda Pharmaceuticals | VTR-297 | Onychomycosis | IND for a phase 1 trial approved by the FDA |
| 23andMe | 23ME-01473 | Advanced solid tumors | IND for a phase 1 trial approved by the FDA |
| Gracell Biotechnologies | GC012F | Early-line treatment of relapsed/refractory multiple myeloma | IND for a phase 1 trial approved by the FDA |
| Jaguar Gene Therapy | JAG201 | A genetic form of autism spectrum disorder and Phelan-McDermid syndrome | IND for a phase 1 trial approved by the FDA |
| Ascidian Therapeutics | ACDN-01 | Stargardt disease and other ABCA4 retinopathies | IND for a phase 1/2 trial approved by the FDA |
| USGI Medical | POSE2.0 incisionless weight loss procedure | Primary obesity | IDE for a pivotal study approved by the FDA |
| Trials Initiated | |||
| Rise Therapeutics | R-2487 | Rheumatoid arthritis | Initiation of a phase 1 trial |
| Tharimmune | TH104 | Primary biliary cholangitis patients with moderate-to-severe chronic pruritus | Initiation of a phase 1 trial |
| Eilean Therapeutics | Eiletoclax | Hematologic and solid malignancies | Initiation of a phase 1 trial in Australia |
| Eilean Therapeutics | Lomonitinib | FLT3 mutated acute myeloid leukemia | Initiation of a phase 1 trial in Australia |
| Uvax Bio | UVAX-1107 and UVAX-1197 HIV-1 vaccine candidates | HIV-1 infection | Initiation of a phase 1 trial in Australia |
| EicOsis | EC5026 | Moderate-to- severe pain | Initiation of a phase 1b trial |
| Bio-Thera Solutions | BAT6026 | Atopic dermatitis | Initiation of a phase 1b/2a trial in China |
| Lixte Biotechnology | LB-100 plus dostarlimab-gxly | Ovarian clear cell carcinoma | Initiation of a phase 1b/2 trial |
| RS Oncology | RSO-021 | Mesothelioma | Initiation of phase 2 portion of a phase 1/2 trial in the UK |
| Kairos Pharma | ENV105 plus apalutamide | Castration-resistant prostate cancer | Initiation of a phase 2 trial |
| Ryvu Therapeutics | RVU120 plus venetoclax | Relapsed/refractory acute myeloid leukemia | Initiation of a phase 2 trial |
| RION | Purified Exosome Product (PEP) | Diabetic foot ulcers | Initiation of a phase 2a trial |
| Aviceda Therapeutics | AVD-104 | Geographic atrophy secondary to age-related macular degeneration | Initiation of phase 2 portion of a phase 2/3 trial |
| Approvals | |||
| Sanofi | Dupixent (dupilumab) | Eosinophilic esophagitis | Approved by the FDA for expanded age indication |
| Takeda | Hyqvia [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] | Maintenance therapy for chronic inflammatory demyelinating polyneuropathy | Approved by the European Commission |
| Hutchmed | Elunate (fruquintinib) | Metastatic colorectal cancer | Approved in China |
| Boston Scientific Corporation | FARAPULSE Pulsed Field Ablation System | Paroxysmal atrial fibrillation | Approved by the FDA |
| Gore Medical | GORE VIABAHN VBX Balloon Expandable Endoprosthesis (VBX stent graft) | Vascular disease | Approved by the FDA |
