Starton Therapeutics Announces FDA Clearance of IND Application

Starton Therapeutics Inc. recently announced the US FDA has cleared an investigational new drug (IND) application for STAR-OLZ in Chemotherapy Induced Nausea and Vomiting (CINV). STAR-OLZ is a multi-day transdermal delivery system (TDS) of olanzapine, covering the standard 5-day CINV treatment period. Independent double blinded studies have shown olanzapine to be a powerful antiemetic, with superiority in the control of nausea compared to other standard of care treatments, including NK1 receptor antagonists. Olanzapine is not approved for any nausea or vomiting indications.

The clinical development program is scheduled to advance in late 2022 with the launch of TROPIC-I, a Phase 2 dose-optimization study in HEC comparing STAR-OLZ an NK1-based triple-regimen with or without STAR-OLZ for CINV in approximately 120 cancer patients receiving highly emetogenic chemotherapy. The study is expected to enroll at an estimated 20+ clinical sites in the US. The study will assess STAR-OLZ superiority in Total Control (defined as no nausea, no vomiting, and no use of rescue medications) and no difference in the control of vomiting compared to the current treatment with combinations containing a 5-HT3, dexamethasone and NK1 antagonist.

“STAR-OLZ represents the first product to be developed for FDA approval using the Total Control primary endpoint, potentially improving outcomes and quality of life for patients,” said Dr. Jamie Oliver, Chief Medical Officer. “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 the need for rescue medications.”

STAR-OLZ has previously completed Phase 1 in-human bioavailability (BA) studies, which demonstrated the transdermal patch has acceptable local tolerability over the 5-day dosing interval and delivers approximately 60% less drug than the oral form.

Olanzapine has been shown to be a powerful antiemetic but is not approved for any nausea or vomiting indications. STAR-OLZ, a multi-day TDS delivery system of olanzapine has been evaluated using a disease-model challenge study to confirm the efficacious blood levels of the drug in nausea and vomiting and a healthy human volunteer study assessed the pharmacokinetics of TDS. STAR-OLZ is in development for two nausea and vomiting indications: CINV and PARP-inhibitor induced nausea and vomiting (PIINV).

CINV is among the most debilitating and feared side-effects of cancer treatment. Current guidelines recommend a three or four drug regimen to prevent CINV for the million people receiving highly emetogenic chemotherapy (HEC) each year in the US (American Cancer Society 2021); however, 60% to 70% still struggle with nausea (Chow 2021).

Starton licensed the rights to develop and commercialize STAR-OLZ in Mainland China to Haisco Pharmaceutical Group. The company intends to retain the rights in the US and is exploring partnerships in the rest of the world.

A clinical-stage biotechnology company focused on transforming standard of care therapies with proprietary continuous delivery technology, so people with cancer can receive continuous treatment to live better, longer. Starton’s proprietary transdermal technology is intended to increase efficacy of approved drugs, to make them more tolerable and expand their potential use. For more information, visit www.startontx.com.