Starton Therapeutics products

STAR-LLD is in development in two continuous delivery systems: subcutaneous and transdermal. STAR-LLD is being developed to establish the only IMiD (immunomodulatory drug) approved for CLL. CLL is the most common form of leukemia. Lenalidomide has been shown to be efficacious and well tolerated in CLL previous randomized controlled trials did not obtain an indication for the product. Even in the absence of a formal approval, NCCN guidelines recommend lenalidomide for the maintenance treatment of CLL. Flattening the plasma concentration curve by reducing the Cmax and increasing the Cmin during a dose interval, continuous delivery is expected to improve tolerability.

STAR-OLZ is a 7-day transdermal patch in development as the first product indicated for PARP inhibitor (PARPi) induced nausea and vomiting (PIINV). PARP inhibitors are a rapidly growing class of cancer therapies currently used in ovarian and breast cancer maintenance therapy, and expected to expand into prostate, pancreatic, lung, and other solid tumors. Nausea and vomiting occur in 77 and 36% of patients respectively, existing antiemetics are contraindicated for use with PARP inhibitors or are not suited for long-term use. Olanzapine is a proven antiemetic, but currently available forms have not been widely adopted in the PARP inhibitor treatment setting due to fear of side effects. STAR-OLZ is designed to improve quality of life and outcomes by controlling PIINV without significant side effects.

STAR-LLD is in development in two continuous delivery systems: subcutaneous and transdermal. STAR-LLD is in development for new multiple myeloma indications for lenalidomide and achievement of superiority versus oral lenalidomide in maintenance treatment of multiple myeloma. The STAR-LLD delivery system is expected to provide significant reductions in discontinuations and treatment abandonment by reducing area under the curve (AUC) by more than 50%+. Lenalidomide is standard of care in multiple myeloma but can have poor tolerability from dose-dependent side effects. Up to 30% of multiple myeloma maintenance patients do not respond to first-line maintenance treatment with lenalidomide (LLD-intolerant due to myelosuppression, adverse events). Flattening the plasma concentration curve by reducing the Cmax and increasing the Cmin during a dose interval, continuous delivery is expected to improve tolerability.

STAR-OLZ is a 5-day transdermal patch in development for the treatment of chemotherapy induced nausea and vomiting (CINV). STAR-OLZ successfully completed Phase 1 human bioavailability studies and is now preparing to advance to a Phase 2 clinical trial. Starton Therapeutics Phase 2 TROPIC-I clinical study will be first to use total control (TC) primary endpoint in superiority study. Total Control is a measure of no nausea, no vomiting, and no rescue medications; existing antiemetics have been approved using a Complete Response (CR) endpoint which only measures vomiting and rescue medications. The standard of care antiemetic regimen for patients treated with highly emetogenic chemotherapy (HEC) results in breakthrough nausea in up to 72% of patients and breakthrough vomiting in up to 50% of patients.

Our continuous dermal delivery systems use an adhesive patch to deliver medicine through the skin. The delivery is a controlled, sustained release over multiple days. Starton uses proven transdermal and subcutaneous technologies to transform approved medicines – establishing superiority or new indications. Starton is focused on flattening the plasma concentration curve to reduce dose-limiting toxicity and deliver improved efficacy.