OnQuality Pharmaceuticals Expands Part 2 of the NOVA-II Phase 2 Clinical Trial to China and India

SEATTLE, Jan. 5, 2023 /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, respectively) and to improve quality of life for patients receiving anticancer medications, today announced that regulatory authorities in China and India have approved Part 2 of the NOVA-II Phase 2 clinical trial, evaluating OQL011, a topical ointment for the management of Hand-Foot Skin Reaction (HFSR) in cancer patients receiving vascular endothelial growth factor receptor (VEGFR) inhibitor(s) (VEGFRi) as part of their anti-cancer treatment. VEGFRi-associated HFSR is a common treatment-related side effect that can cause treatment interruption or discontinuation and contribute to a declining quality of life for patients. There are no treatments with FDA-approved labeling for VEGFRi-associated HFSR. In September 2022, the first patient in Part 2 of the NOVA-II Phase 2 clinical trial was enrolled in the United States. With a multi-regional clinical trial (MRCT), currently with US, India, and China, OnQuality is leveraging its resources to harmonize a robust trial design and global operations across these regions to accelerate recruitment and improve demographic exposure for the target population.

 "The expansion of the Part 2 of the NOVA-II clinical trial to China and India allows patients to access OQL011 in the world's most populated countries," commented Chief Medical Officer and Co-Founder of OnQuality Pharmaceuticals, Hong Tang, M.D., "Data generated in Part 2 will further validate OQL011 and determine the optimal OQL011 dosage for a Phase 3 clinical trial."

 "Adding sites in China and India will increase the scale of NOVA-II Part 2 to a total of 31 clinical sites and help to accelerate the development of OQL011," said Michael McCullar, Chief Executive Officer of OnQuality, "We are excited to expand NOVA-II to a global scale and look forward to including additional countries in the Phase 3 study."

NOVA-II is a 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 VEGFRi-associated HFSR. Patients eligible for the NOVA-II study must be receiving VEGFRi-based anticancer therapy (monotherapy or combination therapy) and have HFSR severity (per IGA-HFSR) of grade 3 or higher (i.e., moderate to severe HFSR). 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.

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

VEGFRi-associated HFSR is characterized by redness, swelling, discomfort or pain, and blistering in the palms of the hands or the soles of the feet. Incidence 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 locally activates VEGF downstream signaling pathways to treat HFSR. OQL011 improves or restores VEGF signaling in cell viability and functionality to alleviate HFSR symptoms. By addressing side effects, OnQuality aims to keep patients in cancer treatment and to improve their quality of life. 

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

OnQuality Pharmaceuticals is dedicated to pioneering the discovery and development of targeted oncology supportive 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 supportive 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