TearSolutions, Inc. announced two major FDA designations—and a phase 2 clinical trial initiation—for lacripep, its investigational ophthalmic therapeutic for the treatment of neurotrophic keratitis (NK).
First up: this company.
The privately-held biopharmaceutical company was originally formed in 2013 as a spin-off from the University of Virginia, based on National Eye Institute (NEI)-funded research into tear composition.
- That research was led by TearSolutions co-founder and Chief Scientific Officer Gordon W. Laurie, PhD, FARVO, a professor of cell biology and ophthalmology.
Its scientific approach: Stems from the discovery of lacritin, a naturally occurring protein in human tears that’s also selectively deficient in most forms of ocular surface disease (OSD)—including dry eye and corneal disease (such as NK).
And where does that candidate come in?
This scientific discovery of lacritin led to the subsequent identification of a key bioactive fragment within the protein that serves as the basis for TearSolutions’ lead candidate: lacripep.
Tell me about it.
Lacripep is a first-in-class peptide therapy derived from that aforementioned deficiency of the lactrin protein (more specifically: it’s a synthetic 10-amino acid fragment of the protein).
Its purpose: Is to act as a replacement for lacritin by restoring homeostasis to the ocular surface.
How it does this: Via topical administration (as an eye drop) and a mechanism of action (MOA) that involves repairing the corneal epithelium’s barrier function and restoring the normal function of sensory nerves.
And the intended result?
The thought is that by repairing and restoring, the therapeutic should (ideally) re-establish the natural production of all three tear film layers: aqueous, lipid, and mucin.
- Read up on how tear film instability within these layers is a key driver behind OSD development.
Also worth noting: The clinical data on lacripep so far looks promising.
Before we talk clinical research, let's get into these new designations.
But of course. The FDA has granted lacripep the following for its NK indication:
- Orphan Drug designation
- Fast Track designation
- Expedites the development and regulatory review process of investigational therapeutics intended to treat serious medical conditions with unmet needs
- See here for advantages accompanying this status (most prominently: priority review and rolling submission of a future new drug application [NDA] submission)
Nice! Now talk about lacripep’s clinical performance thus far.
Starting with its preliminary data: When administered topically in animal models, lacripep restored basal tearing without irritation and healed the eye’s corneal surface.
And more recently: Lacripep was evaluated in a (now completed) first-in-human (FIH) phase 1/2 clinical trial for primary Sjögren’s Syndrome, with the results finding a rapid improvement in corneal health
- The results appeared as early as 2 weeks via a rapid improvement in corneal health and reduction in symptoms.
… and what about that phase 2 trial mentioned earlier?
Officially kicked off earlier this year, this is a multicenter, randomized, vehicle-controlled, double-masked-to-open-label study (NCT07568730) being conducted at three clinical site locations across the United States.
Its purpose: To evaluate lacripep’s safety and effect on the ocular surface, visual function, corneal sensitivity, and quality of life (QOL) among patients with stage 1 NK.
Give me more on these participants
Per Clinical Trials, the study is enrolling an estimated 54 patients (aged 18+) diagnosed with Stage 1 NK based on the following criteria (which must be present in at least one eye):
- Grade 3 corneal fluorescein staining (cCFS) using the NEI scale (0-3 in one-point increments)Corneal sensitivity ≤4 cm in the central zone, as measured by Cochet-Bonnet aesthesiometer
- Best-corrected distance visual acuity (BCDVA) +0.2 to +1.0 logarithm of the minimum angle of resolution (logMAR) (Snellen equivalent 20/32 to 20/200)
- Intraocular pressure (IOP) ≤21 mmHg
See here for exclusion criteria.
And the setup?
In general: Lacripep (as a 4 μM ophthalmic solution) will be compared to a vehicle ophthalmic solution.
But more specifically:
- Patients will first enter a 2-week run-in period with the open-label vehicle.
- At baseline, eligible patients will be randomized to either lacripep or the vehicle
- The dosing for each will be three times a day (TID) in both eyes (OU) for 8 weeks
- Clinic visits will be at Weeks 2, 4, and 8.
What happens at week 8?
The study won’t be done yet. At the Week 8 visit, patients will be assigned to open-label treatment with lacripep for 4 weeks (through Week 12), continuing with TID in both eyes.
- The reason for this: To explore the “potential effects of both a shorter and longer treatment period,” with:
- 4 weeks of active treatment for subjects originally randomized to vehicle
- 12 total weeks of active treatment for subjects originally randomized to lacripep
Got it. And what are the outcome measures?
Measured from baseline to Week 8:
- Primary efficacy: change in cCFS in the study eye
- Secondary efficacy: change in central corneal sensitivity in the study eye
Lastly: When is the study expected to conclude?
The primary and secondary completion dates are estimated for February and March 2027, respectively.