OnQuality Pharmaceuticals Announces the Enrollment of the First Patient in Part 2 of the NOVA-II Phase 2 Clinical Trial

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Nov 08, 2022, 08:00 ET

SEATTLE, Nov. 8, 2022 /PRNewswire/ -- OnQuality Pharmaceuticals ("OnQuality"), a targeted oncology supportive therapy company developing innovative medications to address unmet needs in oncodermatology and oncogastroenterology (cancer therapy-induced side effects occurring in the skin and gastrointestinal tract) and to improve quality of life for patients receiving anticancer medications, today announced the enrollment of the first patient in Part 2 of the NOVA-II Phase 2 clinical trial. NOVA-II trial is evaluating OQL011, a topical ointment for the management of Hand-Foot Skin Reaction (HFSR) in cancer patients receiving vascular endothelial growth factor receptor inhibitor(s) (VEGFRi) as part of their treatment.

"Our team is delighted to start Part 2 of the NOVA-II clinical trial to address the unmet need of cancer-therapy-induced skin toxicities," commented Chief Medical Officer and Co-Founder of OnQuality Pharmaceuticals, Hong Tang, M.D. "OQL011 generated positive initial findings in Part 1 of the Phase 2 study and we look forward to advancing the Part 2 study to determine the optimal dosage of OQL011 for Phase 3."

NOVA-II is a global multicenter, randomized, double-blinded, vehicle-controlled, dose-ranging Phase 2 clinical trial designed to assess the safety and efficacy of OQL011 as a topical ointment in treating VEGFR inhibitor-associated HFSR. Patients eligible for the NOVA-II study must be receiving VEGFR inhibitor-based anticancer therapy (monotherapy or combination therapy) and have HFSR severity (per IGA-HFSR) of grade 3 or higher. Initial findings from Part 1 of the Phase 2 trial showed OQL011 to be safe and well tolerated with no significant adverse events.

Key objectives in the study include evaluating the safety and efficacy of OQL011, identifying an optimal dosage for Phase 3, and exploring the pharmacokinetics profile of OQL011 in HSFR patients. Please refer to www.clinicaltrials.gov (NCT04088318) for additional details.

About Hand-Foot Skin Reaction and OQL011
Hand-Foot Skin Reaction (HFSR) is a common side effect of tyrosine kinase inhibitors, including vascular endothelial growth factor receptor (VEGFR) inhibitors, used to treat cancer. VEGFR inhibitors impair vascular repair mechanisms, which are especially important in areas exposed to high pressure and repetitive force, such as the palms and soles.

VEGFR inhibitor associated HFSR is characterized by redness, swelling, discomfort or pain, and blistering in the palms of the hands or the soles of the feet. Incident rates can exceed 50% of patients treated depending on the inhibitor used. In cases of severe HFSR, dose reduction or discontinuation is required. There is currently no FDA-approved therapy for the treatment of HFSR and the effectiveness of current symptom relief strategies remains limited.

OQL011 is a proprietary ointment that targets the key pathway of VEGFR inhibitor-associated HFSR and may improve or restore VEGF signaling and potentially alleviate HFSR symptoms. By addressing side effects, OnQuality aims to keep patients in cancer treatment and improve their quality of life.

IGA-HFSR: It is an investigator global assessment scale developed by OnQuality in collaboration with key oncodematologists and oncologists for the evaluation of treatment efficacy for VEGFRi-associated HFSR.

About OnQuality Pharmaceuticals
OnQuality Pharmaceuticals is dedicated to pioneering the discovery and development of targeted supportive oncology therapies that address treatment-related toxicities at their molecular source. By treating on-target toxicities of the anticancer treatments, OnQuality's targeted supportive therapy candidates have the potential to reduce the severity and incidence of adverse events while sustaining the efficacy of the cancer treatments. OnQuality's targeted therapies, therefore, can potentially improve both the quality of life and outcomes for cancer patients.

OnQuality is leveraging its proprietary, AI-enabled CARE platform to identify targets and drug candidates to develop first-in-disease targeted supportive therapies addressing unmet medical needs in the emerging areas of oncodermatology and oncogastroenterology. This includes VEGFR inhibitor-induced Hand-Foot Skin Reaction, capecitabine-induced Hand-Foot Syndrome, epidermal growth factor receptor (EGFR) inhibitor-induced skin toxicity, chemotherapy-induced diarrhea, and the gastrointestinal side effects of immunotherapies. For more information about OnQuality Pharmaceuticals, please visit www.onqualityrx.com.

SOURCE OnQuality Pharmaceuticals