Our focus is on delivering meaningful patient outcomes by leveraging the untapped potential of continuous delivery and dermal technology.
Continuous delivery platform allows for lower AUC, Cmax, and overall drug exposure.
Potential for improved efficacy and tolerability, and the pursuit of new indications or superiority in existing indications.
STAR-LLD in MM
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).
A Phase 1 clinical study successfully evaluated the pharmacokinetics (PK) and safety of STAR-LLD, meeting all primary and secondary endpoints. A Phase 1b study is currently ongoing evaluating the safety, efficacy, and PK of continuous subcutaneous administration of low-dose STAR-LLD in patients with multiple myeloma.
STAR-LLD in CLL
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.
A Phase 1 clinical study successfully evaluated the pharmacokinetics (PK) and safety of STAR-LLD, meeting all primary and secondary endpoints. The product will be further evaluated in a randomized Phase 1b/2 study in patients with CLL.
STAR-OLZ in CINV
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.
STAR-OLZ technology allows for sustained release efficacy protection for at least five days. The product is in development to substitute NK1 receptor antagonists in the guideline-recommended CINV prophylaxis regimen.
STAR-OLZ in PIINV
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.
Platform Dermal Technology
Our strategic platform provides 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.
- Deliver between 50% to 90% lower AUC with equal or better tumor control vs oral
- Avoidance of toxicity due to the lower AUC may allow patients to continue treatment with the avoidance of withdrawals and dose-limiting toxicity, inherently leading to longer progression-free survival (PFS)
- Eliminate periods of subtherapeutic dosing due to short half-life
With each program, we establish an AUC target to identify the blood level (mcg/L) point estimate with oral administration where half of the dose interval is above the point estimate and half of the dose interval is below the point estimate. Using this mid-point method, the total AUC is lower than that observed with oral daily dosing which may reduce the toxicity observed with a higher AUC while maintaining efficacy.
