Starton Therapeutics has announced the successful delivery of its low-dose lenalidomide formulation, STAR-LLD, using BD's on-body injector technology. This innovative approach offers a continuous subcutaneous delivery method as an alternative to the traditional oral pill form, Revlimid (lenalidomide). The company is gearing up for Phase II trials in chronic lymphocytic leukemia (CLL) and multiple myeloma in 2025, building on positive early trial results.
On-Body Injector Technology
The on-body injector is a wearable device designed to administer medication continuously under the skin via a small needle. This allows patients to receive controlled doses of medication over time while maintaining their daily routines. Starton's successful demonstration of this technology confirms its ability to deliver STAR-LLD at a consistent, low dose.
Phase Ib Trial Results
Earlier this year, Starton reported positive early results from its Phase Ib trial (NCT06087653) involving patients with multiple myeloma. The trial evaluated the efficacy and safety of STAR-LLD continuous subcutaneous delivery compared to once-daily Revlimid oral delivery. The study met all primary and secondary endpoints, indicating the potential for improved patient outcomes with the on-body injector method.
Future Clinical Trials
Building on the success of the Phase Ib trial, Starton is planning larger Phase II trials for chronic lymphocytic leukemia (CLL) and multiple myeloma in 2025. These trials aim to further validate the benefits of STAR-LLD and the on-body delivery system in a larger patient population.
Management Perspective
Starton’s CEO, Pedro Lichtinger, stated, “The positive results from this study enable us to expand the use of STAR-LLD, which is expected to lead to improved quality of life for patients undergoing lenalidomide treatment. We believe the on-body technology provides the convenience, comfortability, and patient/oncologist acceptability for significantly increasing the number of patients that can benefit from STAR-LLD.”
Transdermal Drug Delivery Landscape
Founded in 2017, Starton focuses on transdermal technology to enhance the efficacy and tolerability of approved drugs, potentially expanding their use to other indications. GlobalData analysis identifies Starton as a key player in the active development of transdermal drug delivery. Other notable companies in this space include Medherant, which is developing a testosterone patch for postmenopausal women, as well as 4P Therapeutics, MEDRx, Nemaura Pharma, Sinsin Pharmaceutical, and Icure Pharmaceutical.
