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Drug & Device Pipeline News
This week’s Pipeline features a phase 1/2 trial approval for geographic atrophy, a phase 3 trial start for PSMA+ metastatic castration-resistant prostate cancer, and an FDA approval for a chikungunya virus vaccine.
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| Trials Authorized | |||
| Inflammasome Therapeutics | Kamuvudines | Geographic atrophy | IND for a phase 1/2 trial approved by the FDA |
| Artax Biopharma | AX-158 | Mild-to-moderate plaque psoriasis | Approval for a phase 2a trial granted by the UK’s regulatory authority |
| IntelGenx | Montelukast VersaFilm | Parkinson’s disease | Approval for a phase 2 trial granted by Sweden’s regulatory authority |
| Tenax Therapeutics | TNX-103 (oral levosimendan) | Pulmonary hypertension with heart failure with preserved ejection fraction | IND for a phase 3 trial approved by the FDA |
| Awakn Life Sciences | AWKN-P001 (ketamine plus psycho-social support) | Severe alcohol use disorder | Approval for a phase 3 trial granted by the UK’s regulatory authority |
| Trials Initiated | |||
| Orionis Biosciences | ORB-011 | Advanced solid tumors | Initiation of a phase 1 trial |
| Incendia Therapeutics | PRTH-101 | Advanced/ metastatic solid tumors | Initiation of a phase 1b trial |
| Alentis Therapeutics | ALE.C04 | CLDN1+ head and neck tumors | Initiation of a phase 1/2 trial |
| Ocugen | OCU410ST gene therapy | Stargardt disease | Initiation of a phase 1/2 trial |
| Vaxcyte | VAX-31 31-valent pneumococcal conjugate vaccine | Invasive pneumococcal disease in adults | Initiation of a phase 1/2 trial |
| JCR Pharmaceuticals | JR‑441 | Mucopolysaccharidosis type IIIA | Initiation of a phase 1/2 trial |
| Carmot Therapeutics | CT-868 | Overweight or obese adults with type 1 diabetes | Initiation of a phase 2 trial |
| Cerevance | CVN424 | Early-stage Parkinson’s disease | Initiation of a phase 2 trial |
| Trishula Therapeutics | TTX-030 plus chemotherapy with and without budigalimab | Metastatic pancreatic ductal adenocarcinoma | Initiation of a phase 2 trial |
| Senhwa Biosciences | Silmitasertib (CX-4945) | Treatment of adults hospitalized with COVID-19 | Initiation of a phase 2 trial in Taiwan |
| SciSparc | SCI-110 | Tourette syndrome | Initiation of a phase 2b trial |
| Bayer | Asundexian (BAY2433334) | Treatments of patients age 65 or older with atrial fibrillation at high risk for stroke or systemic embolism who are ineligible for oral anticoagulant treatment | Initiation of a phase 3 trial |
| Telix Pharmaceuticals | TLX591 (177Lu-rosopatamab tetraxetan) plus standard of care | PSMA+ metastatic castration-resistant prostate cancer | Initiation of a phase 3 trial |
| Approvals | |||
| Bristol Myers Squib | Augtyro (repotrectinib) | Locally advanced/ metastatic ROS1+ non-small cell lung cancer | Approved by the FDA |
| Takeda Pharmaceuticals | Adzynma (ADAMTS13, recombinant-krhn) | Congenital thrombotic thrombocytopenic purpura | Approved by the FDA |
| Valneva Austria | Ixchiq (chikungunya vaccine, live) | Chikungunya virus | Approved by the FDA |
| Ipsen Medison Pharma |
Bylvay (odevixibat) | Pruritus in patients age 6 months or older with progressive familial intrahepatic cholestasis | Approved by Health Canada |
| CorMedix | DefenCath (taurolidine and heparin) catheter lock solution | Catheter-related bloodstream infections in adults with kidney failure receiving chronic hemodialysis through a central venous catheter | Approved by the FDA |
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