CID is a common and often debilitating toxicity affecting up to 90% of patients receiving chemotherapy. CID can cause dehydration, electrolyte imbalance, malnutrition, and infection, which may lead to hospitalization, cardiovascular compromise, and in some cases death. Prevention of moderate to severe CID often requires dose reduction. Treatment of CID may require interruption or even permanent discontinuation of chemotherapy, and potentially compromising the effectiveness of cancer therapy.

OQL051 – a first-in-disease, oral, gut-restricted CDK4/6 inhibitor – is designed to prevent the development of CID in patients receiving cytotoxic chemotherapies. The drug works by temporarily arresting the rapidly dividing intestinal mucosal cells in G1 phase. OQL051 locally targets cells of the digestive tract, transiently preventing cell division. This protects the intestinal lining from chemotherapy damage. Preclinical studies have demonstrated that OQL051, when given prior to chemotherapy, delays the onset and reduces the severity of CID without compromising the anti-tumor activity of chemotherapy agents.

"We are delighted to receive IND clearance for OQL051. This is a significant milestone for OnQuality and for patients suffering from CID," said Hong Tang, MD, FACP, Chief Medical Officer at OnQuality. "Prevention of CID is a major unmet medical need. We believe that OQL051 has the potential to make a meaningful difference in the lives of patients who suffer from cancer and the toxic effects of cancer treatment."

"Along with the OQL036 (for the prophylaxis of capecitabine-induced hand-food syndrome in onco-dermatology) clinical clearance by FDA in April this year, the newly cleared OQL051 allows us to advance our drug development in onco-gastroenterology, the second pillar of OnQuality pipeline," added by Jacob Song, Global Regulatory Lead and Director.

OnQuality plans to initiate a Phase I/II clinical trial in coming months to evaluate the safety in healthy volunteers, as well as safety and preliminary efficacy of the drug in cancer patients who plan to receive fluorouracil (5-FU) and irinotecan-based chemotherapy.