OnQuality Pharmaceuticals Announces Completion of Part 1 of NOVA-II Trial

- Top-line readout of clinical study results anticipated by the end of 2021

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Sep 07, 2021, 08:00 ET

SEATTLE, Sept. 7, 2021 /PRNewswire/ -- OnQuality Pharmaceuticals ("OnQuality"), a targeted cancer supportive care company developing medications to address specific side effects and improve quality of life for patients receiving cancer medications, today announced the completion of part 1 of the NOVA-II Phase 2 trial evaluating OQL011, a topical ointment to treat cancer therapy-induced skin toxicities.

The trial was designed to allow an analysis of the Part 1 data prior to the initiation of Part 2. OnQuality will seek cooperation with the U.S. Food and Drug Administration (FDA) on the designs of future studies. The company will present its findings from Part 1 at a future conference.

"We are pleased with the completion of the first part of the study, which is an important milestone for the company," said Hong Tang, M.D., Chief Medical Officer and co-founder of OnQuality Pharmaceuticals. "The study further validates the unmet need for innovative new approaches to cancer supportive care. We remain focused on analyzing the data and look forward to sharing them soon."

NOVA-II is a multicenter, randomized, double-blinded, placebo-controlled, dose-ranging Phase II clinical trial of OQL011, designed to assess the safety and efficacy of OQL011 as a topical ointment in treating Hand-Foot Skin Reaction (HFSR) for patients currently receiving VEGFR inhibitor-based anticancer therapy (monotherapy or combination therapy), and whose HFSR severity (per NCI CTCAE v5.0 grading of palmer-plantar erythrodysesthesia) is grade 2 or higher.

Key objectives in the study included determining the efficacy, safety, pharmacokinetics of OQL011, and improvement in patient-reported outcomes including pain. Please refer to www.clinicaltrials.gov (NCT04088318) for additional details.

About OQL011

OQL011 is a proprietary ointment that activates VEGF downstream signaling pathways. VEGFR inhibitors impair the vascular repair mechanisms especially in areas exposed to high pressure and repetitive force, such as the palms and soles, where blood vessels are more likely to be damaged and more in need of intact vascular repair mechanisms. OQL011 improves or restores VEGF signaling in cell viability and functionality with VEGFR inhibitors.

About Hand-Foot Skin Reaction

Hand-Foot Skin Reaction (HFSR) commonly occurs with tyrosine kinase inhibitors such as vascular endothelial growth factor receptor (VEGFR) inhibitors. It is characterized by redness, swelling, discomfort or pain, and even blistering in the palms of the hands or the soles of the feet. Depending on the inhibitor used, incident rates can exceed 50% of patients treated.

Current treatment strategies are focusing on symptom relief using moisturizing cream, cold packs,
urea cream or topical steroids. In cases of severe HFSR, dose reduction or discontinuation is required. There is currently no FDA-approved therapy for the treatment of HFSR.

About OnQuality Pharmaceuticals

OnQuality Pharmaceuticals is dedicated to pioneering the discovery and development of targeted cancer supportive care therapies that address treatment-related toxicities at their molecular source. OnQuality's targeted cancer supportive care therapies may have the potential to improve both quality-of-life and outcomes for cancer patients. By treating on-target toxicities of the anti-cancer treatments, we believe OnQuality's targeted supportive care candidates have the potential to reduce the severity and incidence of adverse events while sustaining the efficacy of the cancer treatments. OnQuality is advancing several oncodermatology and oncogastroenterology pipeline products to address leading skin and gastrointestinal toxicities such as VEGFR inhibitor-induced Hand-Foot Skin Reaction, capecitabine-induced Hand-Foot Syndrome, epidermal growth factor receptor (EGFR) inhibitor-induce skin rash and chemotherapy-induced diarrhea. For more information about OnQuality Pharmaceuticals, please visit www.onqualityrx.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements that are often identified by the words "may", "might", "believes", "thinks", "anticipates", "plans", "expects", "intends" or other similar expressions. In addition, expressions of our strategies, intentions or plans are also forward-looking statements. Although forward-looking statements contained herein are based on what OnQuality Pharmaceuticals believes are reasonable assumptions, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. OnQuality undertakes no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements.