Setara Biosciences has launched with $90 million to advance a drug candidate aimed at Charcot-Marie-Tooth disease type 2C, a rare neuromuscular disorder, while also pursuing development for overactive bladder. The San Diego-based company’s lead program, STAR-0871, is in early clinical development.
The startup was created from rare-disease assets associated with Actio Biosciences after Jazz Pharmaceuticals acquired Actio for its epilepsy drug candidate. The companies had said Actio’s rare-disease programs would be separated into a new business. STAR-0871 was previously known as ABS-0871.
A drug candidate inherited from Actio
STAR-0871 is a small-molecule inhibitor of TRPV4, an ion-channel protein expressed throughout the body. Actio used a human-genetics platform to identify possible drug targets and study their role in disease. In Charcot-Marie-Tooth disease type 2C, mutations in the TRPV4 gene cause abnormally active ion channels that contribute to peripheral nerve damage.
Setara is developing STAR-0871 to selectively inhibit TRPV4 and address the biological mechanism linked to the disorder. Charcot-Marie-Tooth disease type 2C currently has no FDA-approved therapies, according to MedCity News. The drug’s potential use in overactive bladder comes from TRPV4’s role in detecting bladder fullness. The condition affects millions of people, while the available treatment options have limited efficacy, the publication reported.
Clinical development plans
A Phase 1 study of the TRPV4 inhibitor was already underway when Jazz announced its acquisition of Actio in August. Setara said the portion involving healthy volunteers has been completed. The company plans to expand that work into a Phase 1b study with patients who have Charcot-Marie-Tooth disease next year.
| Program | Indication | Development status |
|---|---|---|
| STAR-0871 | Charcot-Marie-Tooth disease type 2C | Phase 1 healthy-volunteer portion complete; Phase 1b planned |
| STAR-0871 | Overactive bladder | Separate Phase 2a trial planned |
In parallel, Setara plans a separate Phase 2a trial in overactive bladder. Those studies are planned stages of development, not evidence that the drug is effective or safe for either condition. The available clinical information describes the study progression but does not provide efficacy results or establish whether STAR-0871 will receive regulatory approval.
Additional programs remain earlier stage
Setara also holds discovery-stage programs inherited from Actio for epilepsy and migraine. The targets for those programs have not been disclosed. Actio’s most advanced research program beyond the lead asset was a small-molecule inhibitor of KCNT1 ion channels, according to MedCity News.
- Financing: Setara launched backed by $90 million.
- Lead asset: STAR-0871 is a TRPV4 inhibitor for Charcot-Marie-Tooth disease type 2C and overactive bladder.
- Next clinical steps: Patient testing in a Phase 1b study is planned for Charcot-Marie-Tooth disease, alongside a planned Phase 2a study in overactive bladder.
