Zhaoke Ophthalmology Limited ("Zhaoke Ophthalmology" or the "Company") successfully recruited its first patient for a Phase II clinical trial in China for ZKY001, a potential first-in-class eye drop targeting corneal epithelial defects ("CED"), through anti-inflammatory effects plus stimulation of epithelial cell migration, in a Phase II clinical trial in China on 24 December 2020.
The ongoing Phase II clinical trial is a multi-center, randomized, double-masked, placebo-controlled study to evaluate the safety and efficacy of ZKY001 for the treatment of CED after endothelial keratoplasty, a cornea transplant surgery to restore vision when the inner cell layer of the cornea stops working properly. Such surgery inevitably damages the corneal epithelium. This trial also aims to assess the dosage of ZKY001 for future development.
The clinical trial is designed to enroll a total of 105 subjects, who will receive 0.002% ZKY001 (n=35), 0.004% ZKY001 (n=35) or placebo (n=35) four times daily for a 14±2-day dosing period. The administration will begin on day 1 after surgery. The primary endpoint of this trial is the average area of repaired cornea on day 3. The key secondary endpoints include improvement of signs and symptoms of CED from baseline on day 3, 6 and 15, and the average area of repaired cornea on day 2, 4 and 5.
Compared to widely prescribed growth factor therapies, such as rh-EGF and rb-bFGF drugs, which stimulate angiogenesis and may cause edema and inflammation, ZKY001 showed better in vivo efficacy in reducing corneal swelling and suppressing abnormal ocular vessel growth in preclinical animal models. ZKY001 also has a favorable safety profile, well tolerated at all concentrations in one of its Phase I clinical trials. It is believed that ZKY001 has the potential to be a foundational therapy for a broad range of corneal epithelial diseases.
ABOUT ZKY001
ZKY001, one of the core products of the Company, is a potential first-in-class eye drop targeting CED, the partial or complete loss of the epithelial cells in the cornea. ZKY001 is based on a peptide composed of seven amino acids, LQ-7, which is the functional fragment of Thymosin ß4 that binds with actin, a type of protein that plays a central role in cell structure and movement. Through its regulation of actin, LQ-7 is able to accelerate corneal epithelial wound repair and enhance epithelial cell migration.
CED is the partial or complete loss of the epithelial cells in the cornea, which could lead to inflammatory responses on the ocular surface, or even stromal keratopathy, a serious corneal condition that may cause permanent vision loss. CED may be caused by mechanical traumas, infections and inflammation on the ocular surface due to diseases such as diabetes and dry eye disease. CED may also be caused by neurotrophic abnormalities that lead to decreased production of tears, post-surgery corneal damages and side effects from preservatives in ophthalmic drugs. It is usually associated with pain, tearing and foreign body sensation of the affected eye, and patients may also experience blurry vision, redness, photophobia, pain with blinking and eye movement.
Currently ZKY001 is the only clinical-stage CED drug candidate in China. It is not a growth factor and does not cause angiogenesis. It employs an innovative mechanism for CED treatment through anti-inflammatory effects plus stimulation of epithelial cell migration. The Company had completed two preclinical studies to evaluate ZKY001’s efficacy for the treatment of CED and a Phase I clinical trial to evaluate ZKY001’s safety, tolerability and systemic pharmacokinetics in healthy subjects. Subsequent to the completion of the first Phase I clinical trial, the Company consulted the Center for Drug Evaluation (“CDE”) of National Medical Products Administration for initiating its Phase II clinical trial. According to the Company’s correspondence with the CDE, it is understood that the CDE is of the view that the currently available safety data (including the preclinical studies and the completed Phase I clinical trial) have provided sufficient support to the safety profile of ZKY001 to proceed to subsequent trials.
