The Sponsor is developing KB801, a replication-defective, non-integrating herpes simplex virus type 1 (HSV-1)-derived vector engineered to deliver functional full-length human nerve growth factor (NGF) to the corneas of people with Stage 2 or 3 neurotrophic keratitis (NK) via topical application. This is a Phase 1/2, multicenter, double-masked, placebo-controlled study to evaluate the safety, tolerability, and preliminary efficacy of KB801 in these subjects.
The subject must have read, understood, and signed an Institutional Review Board (IRB) approved Informed Consent Form and must be willing and able to comply with study procedures and instructions.
Aged ≥ 18 years at the time of informed consent.
Diagnosis of Stage 2 or Stage 3 NK, as defined by the Mackie criteria.
Persistent corneal epithelial defect (PCED) between Screening 1 and Screening 2 without clinical improvement during that time. PCED is defined as a focal loss of the cornea's outermost cell layer and can include involvement of the deeper stromal layers (i.e., corneal ulcer).
An active ocular infection (bacterial, viral, fungal or protozoal) or active ocular inflammation not related to NK in the study eye as assessed by Investigator at Screening 1 or 2.
Use of any prohibited therapies at Screening or anticipated need for topical treatments other than the investigational product or products allowed per protocol in the study eye from Screening through the study Treatment Period
Anticipated use of therapeutic contact lenses or contact lens wear for refractive correction during the study Treatment Period in the study eye.
Evidence of corneal ulceration involving the posterior third of the corneal stroma, corneal melting, descemetocele, impending or perforation in the study eye at the time of Screening 1 or 2.
Parallel
KB801
Biological/VaccineOphthalmic suspension of replication-defective, non-integrating herpes simplex virus type 1 (HSV-1)-based vector delivering functional, full-length human nerve growth factor (NGF)
Placebo
DrugVehicle
To evaluate safety and tolerability of KB801 based upon assessment of adverse events (frequency, severity, relatedness).
Number of subjects with treatment related adverse events as assessed by CTCAE v5.
To evaluate the effect of KB801 on complete healing of the Persistent Corneal Epithelial Defect (PCED) in subjects with Stage 2 or Stage 3 NK
Proportion of subjects receiving KB801 exhibiting complete PCED closure at Week 8 compared to those receiving placebo.
To evaluate the effect of KB801 on complete healing of the PCED in subjects with Stage 2 or 3 NK
Proportion of subjects receiving KB801 with complete PCED closure at Weeks 4, 6 and 10 compared to those receiving placebo.
To evaluate the effect of KB801 on conventional healing of the PCED in subjects with Stage 2 or 3 NK
Proportion of subjects receiving KB801 achieving \<0.5-mm lesion size at Weeks 4, 6, 8, and 10 compared to those receiving placebo.
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