Wuhan Hiteck Biopharmaceutical Co., Ltd. reports that results from a Phase I clinical study of HT006.2.2, a recombinant human nerve growth factor ophthalmic formulation developed by the company, have been published in the European Journal of Pharmaceutical Sciences (EJPS), a Q1 peer reviewed scientific journal.

The study evaluated the safety and tolerability of HT006.2.2 in healthy adult volunteers. The results demonstrated a favorable safety and tolerability profile across all tested dose levels. These findings support the continued clinical development of HT006.2.2 for patients with neurotrophic keratitis.

Study Design and Key Results

The Phase I clinical study, registered under ChiCTR2500100332, was conducted at Beijing Tongren Hospital. It was designed to assess safety, tolerability, immunogenicity and pharmacokinetic characteristics of HT006.2.2 following ocular administration in healthy Chinese adults.

A total of 161 participants received HT006.2.2 across three study segments.

Key observations from the study include:

• HT006.2.2 demonstrated good tolerability at concentrations ranging from 5 to 120 micrograms per milliliter in both single administration and repeated administration cohorts
• No maximum tolerated dose was identified at the highest tested concentration of 120 micrograms per milliliter
• No clear relationship between dose level and the incidence of treatment emergent adverse events was observed
• The overall rate of treatment emergent adverse events in HT006.2.2 groups did not exceed that observed in the placebo group
• Most adverse events were mild in severity and resolved within a short period without intervention
• No systemic exposure was detected and no anti drug antibodies were identified at the evaluated dose levels

Scientific Background of rhNGF

Neurotrophic keratitis is a rare degenerative corneal disorder caused by impairment of corneal sensory innervation. The condition may lead to persistent epithelial defects and, in severe cases, corneal ulceration and vision loss. Current treatment options remain limited.

Recombinant human nerve growth factor has been investigated for its potential role in promoting corneal nerve regeneration and epithelial healing. However, existing rhNGF products face challenges related to storage conditions and patient access.

HT006.2.2 An Optimized rhNGF Formulation

HT006.2.2 is produced using a CHO S eukaryotic expression system, enabling post translational modifications that closely resemble those of endogenous human nerve growth factor. The formulation incorporates multiple optimization strategies, including:

• Storage stability
  HT006.2.2 can be stored at temperatures between 2 and 8 degrees Celsius for at least 24 months, reducing cold chain requirements during transportation and storage
• Ease of use
  The product is provided in a single dose disposable format, which supports convenient administration, reduces contamination risk and may improve patient adherence
• Cost efficiency
  Optimization of the production process and formulation design contributes to lower overall costs across manufacturing, transportation and storage, potentially improving treatment accessibility

These characteristics may help address several limitations associated with existing rhNGF therapies.

Future Development Plans

Based on the Phase I clinical data, Hiteck plans to advance HT006.2.2 into subsequent clinical studies. These programs are expected to include efficacy focused trials in patients with neurotrophic keratitis, as well as exploration of additional ocular surface and optic nerve related indications where rhNGF may provide clinical benefit.

Reference Press Release

A related international press release summarizing the study results was distributed through AP News.

Read the press release:
https://apnews.com/press-release/getnews/hitecks-rhngf-eye-drops-ht006-2-2-demonstrate-favorable-safety-in-first-in-human-study-published-in-ejps-68904a1eed647fd5743dc0a1949f51ec

About Hiteck

Wuhan Hiteck Biopharmaceutical Co., Ltd. is headquartered in Wuhan, China. The company focuses on the research, development and manufacturing of biologic therapies across ophthalmology, oncology and rare disease areas.

Hiteck’s pipeline includes HT006.2.2, an investigational recombinant human nerve growth factor ophthalmic formulation, as well as Aponermin for the treatment of hematologic malignancies.

Company: Wuhan Hiteck Biopharmaceutical Co., Ltd.
Website: https://www.hiteckpharma.com
Contact: 4001881552
Email: Hiteck2000@163.com
Address: Hiteck Science and Technology Park, Wuhan Economic and Technological Development Zone, Wuhan, Hubei Province, China