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Drug & Device Pipeline News
September 25, 2023
This week’s Pipeline features approval of an IDE for a study of an atrioventricular interval modulation therapy, two cancer drug approvals from the European Commission and initiation of a phase 1 trial for an HIV vaccine.
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| Trials Authorized | |||
| Hepagene Therapeutics | HPG7233 | Non-alcoholic steatohepatitis and dyslipidemia | IND for a phase 1 trial approved by the FDA |
| LAPIX Therapeutics | LPX-TI641 | Multiple sclerosis | IND for a phase 1 trial approved by the FDA |
| Osmol Therapeutics | OSM-0205 | Chemotherapy-induced peripheral neuropathy | IND for a phase 1 trial approved by the FDA |
| Innocare Pharma | ICP-189 plus furmonertinib | Non-small cell lung cancer | IND for a phase 1 trial approved by China’s regulatory authorities |
| Oscotec ADEL |
ADEL-Y01 | Alzheimer's disease | IND for a phase 1a/1b trial approved by the FDA |
| Creative Medical Technology | StemSpine using AlloStem (CELZ-201-DDT) | Chronic lower back pain | Approval for a phase 1/2 trial granted by the FDA |
| Pulmatrix | PUR3100 (dihydroergotamine mesylate inhalation powder) | Acute migraine | IND for a phase 2 trial approved by the FDA |
| Orchestra BioMed | BackBeat CNT (atrioventricular interval modulation therapy) | Hypertensive patients who are indicated for a dual-chamber cardiac pacemaker | IDE for a pivotal trial approved by the FDA |
| CELL Technologies | Stem cell treatment | Pain and osteoarthritis | No Objection letter issued by Canada’s regulatory authorities for a clinical trial |
| Trials Initiated | |||
| Cerevance | CVN293 | Amyotrophic lateral sclerosis and Alzheimer’s disease | Initiation of a phase 1 trial |
| Drug Pharm | DF-003 | Cardio-renal diseases and ROSAH syndrome | Initiation of a phase 1 trial |
| Vir Biotechnology | VIR-1388 vaccine | HIV vaccine | Initiation of a phase 1 trial |
| Revolution Medicine | RMC-9805 | Cancers with the KRASG12D mutation | Initiation of a phase 1/1b trial |
| ESSA Pharma | Masofaniten plus enzalutamide | Metastatic castration-resistant prostate cancer | Initiation of phase 2 portion of a phase 1/2 trial |
| ImmPACT Bio | IMPT-314 | Relapsed or refractory aggressive B-cell lymphoma | Initiation of a phase 1/2 trial |
| LinKinVax | CD40HVac (HPV vaccine) | HPV-positive oropharyngeal cancer | Initiation of a phase 1/2a trial |
| Protara Therapeutics | TARA-002 intravesical instillation | High-grade nonmuscle invasive bladder cancer in patients with Bacillus Calmette-Guérin (BCG)-naïve and BCG-unresponsive carcinoma in situ | Initiation of a phase 1b/2 trial |
| Cantex Pharmacueticals | Azeliragon | Newly diagnosed unmethylated glioblastoma | Initiation of a phase 2 trial |
| NeuroBo Pharmaceuticals | DA-1241 | Non-alcoholic steatohepatitis | Initiation of a phase 2a trial |
| AffaMed Therapeutics | Dextenza (0.4 mg dexamethasone ophthalmic insert) | Ocular inflammation and pain following ophthalmic surgery | Initiation of a phase 3 trial in China |
| Approvals | |||
| GSK | Ojjaara (momelotinib) | Intermediate or high-risk myelofibrosis patients with anemia | Approved by the FDA |
| Redhill Biopharma | Talicia (amoxicillin, rifabutin and omeprazole) | H. pylori infection | Approved by the FDA for new dosing regimen |
| BeiGene | Tevimbra (tislelizumab) | Previously treated advanced or metastatic esophageal squamous cell carcinoma | Approved by the European Commission |
| Otsuka Pharmaceuticals Astex Pharmaceuticals |
Inaqovi (oral decitabine and cedazuridine) | Adults with newly diagnosed acute myeloid leukemia | Approved by the European Commission |
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