Wuhan Hiteck Biopharmaceutical Co., Ltd. announced that results from the first-in-human Phase I clinical study of its recombinant human nerve growth factor (rhNGF) ophthalmic formulation, HT006.2.2, were recently published in the European Journal of Pharmaceutical Sciences (EJPS), a Q1 peer-reviewed journal. The study demonstrated favorable safety and tolerability across all dose groups in healthy volunteers, supporting the continued advancement of the drug’s clinical development for patients with neurotrophic keratitis (NK).
Study Overview and Key Findings
The Phase I study (ChiCTR2500100332), conducted at Beijing Tongren Hospital, was a randomized, double-blind, placebo-controlled, dose-escalation trial designed to evaluate the safety, tolerability, immunogenicity and pharmacokinetics (PK) of HT006.2.2 in healthy Chinese adults.
A total of 161 participants received HT006.2.2 across three study parts.
∙ HT006.2.2 at doses ranging from 5 to 120 μg/mL exhibited favorable tolerance in both single-dose and multiple-dose cohorts.
∙ At the maximum tested dose of 120 μg/mL, no maximum tolerated dose (MTD) was attained.
∙ No discernible dose-response relationship was observed in the incidence of treatment-emergent adverse events (TEAEs) across dosage groups. Notably, the overall TEAE rate in HT006.2.2 groups did not exceed that of the placebo arm.
∙ The majority of adverse events (AEs) were grade 1 in severity and resolved spontaneously within a short period.
∙ No systemic exposure was detected, and no anti-drug antibodies (ADAs) were formed at the study doses.
Scientific and Clinical Context of rhNGF
Neurotrophic keratitis (NK) is a rare degenerative corneal disease caused by impaired corneal innervation, leading to persistent epithelial defects and, in severe cases, corneal ulceration. Approved treatments remain limited. rhNGF has shown potential in supporting corneal nerve regeneration and epithelial healing, but existing products face challenges related to storage requirements and patient accessibility.
HT006.2.2: An Optimized rhNGF Candidate
HT006.2.2 is an optimized rhNGF formulation expressed using a CHO-S eukaryotic expression system, which enables post-translational modifications closer to natural human NGF. The formulation incorporates structural stabilization enhancements, allowing:
∙ Stable Storage Characteristics: Can be stably stored at 2–8°C for at least 24 months, with lower requirements for cold chain transportation and storage.
∙ Excellent Usability: Adopts single-dose disposable packaging, which not only offers convenient use, but also minimizes the risk of contamination and effectively improves patient medication compliance.
∙ Significant Cost Value: Substantially reduces the comprehensive costs in production, transportation and storage links, thereby helping to enhance treatment accessibility.
These attributes may help address some of the access and convenience limitations of existing rhNGF products.
Future Development
Building on the Phase I results, Hiteck plans to advance HT006.2.2 into subsequent clinical studies, including efficacy-focused trials in patients with neurotrophic keratitis and other ocular surface or optic nerve disorders where rhNGF may demonstrate therapeutic potential.
FAQ
Q1: What is HT006.2.2?
HT006.2.2 is a recombinant human nerve growth factor (rhNGF) ophthalmic formulation independently developed by Wuhan Hiteck Biopharmaceutical Co., Ltd.
Q2: What disease is it intended for?
NGF has been investigated as a potential therapeutic strategy for a range of ocular conditions involving corneal, conjunctival, retinal, or optic nerve injury or degeneration. These include neurotrophic keratitis (NK), corneal ulcers, dry eye disease, retinitis pigmentosa, and glaucoma.
Q3: What were the key findings of the Phase I study?
The study demonstrated that HT006.2.2 eye drops exhibit favorable safety profiles, with no MTD reached, no systemic exposure observed, and no formation of ADAs detected at the study dose. Additionally, the pharmacokinetic characteristics of HT006.2.2 eye drops in tear fluid have been clarified. These findings collectively support the continued advancement of the drug’s clinical development for patients with NK.
Q4: How is HT006.2.2 different from existing rhNGF products?
HT006.2.2 is produced using a CHO-S expression system and incorporates formulation features designed to enhance stability. It remains stable at 2–8°C for at least 24 months and is provided in single-dose packaging to support convenient use and storage.
About Hiteck
Wuhan Hiteck Biopharmaceutical Co., Ltd. (“Hiteck”) is headquartered in Wuhan, China and focuses on the research, development, and manufacturing of biologic therapies, with programs spanning ophthalmology, oncology, and rare diseases. Its pipeline includes HT006.2.2, an investigational recombinant human nerve growth factor (rhNGF) ophthalmic formulation, and Aponermin for hematologic malignancies.
Media Contact
Company Name: Wuhan Hiteck Biopharmaceutical Co., Ltd.
Contact Person: Media Relations
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Phone: 4001881552
Address:Hiteck Science and Technology Park Wuhan Economic and Technological Development Zone
City: Wuhan
State: Hubei Province
Country: China
Website: https://www.Hiteck.com.cn/
