Mimetogen is focusing on the development of tavilermide, a first-in-class synthetic neurotrophin mimetic of nerve growth factor (NGF). The clinical development program for our lead drug, tavilermide (previously known as MIM-D3), is focused on dry eye disease (DED). By activating the NGF receptor, TrkA, tavilermide represents a novel mechanism for promoting ocular surface healing and improvement of tear quality in DED. We believe that tavilermide is a well-positioned entrant for the DED market, due to its novel mechanism of action and outstanding target product profile. A number of clinical trials were initially focused on selecting the appropriate concentration of tavilermide ophthalmic solution (1% or 5%) to demonstrate statistically significant and clinically relevant activity. These studies are summarized below. Tavilermide ophthalmic solution 1% and 5% has been studied in over 900 patients thus far with no observed safety concerns.
Mimetogen is advancing 5% tavilermide ophthalmic solution for the treatment of DED.
Tavilermide 1% and 5% Phase 2 Study
In a Phase 2 study, 150 subjects with dry eye were randomized to 1% tavilermide, 5% tavilermide, or placebo (vehicle) topically instilled in both eyes, twice a day, for 28 days. Key eligibility criteria included moderate signs and symptoms of dry eye plus a demonstration of exacerbation in corneal fluorescein staining and ocular discomfort after exposure to a Controlled Adverse Environment (CAESM). The trial demonstrated significant improvements (p<0.05) for 1% and 5% tavilermide in a number of key approvable signs and symptoms in the intent to treat (ITT) population together with excellent safety and tolerability profiles1.
Tavilermide 1% Phase 3 Studies
Three Phase 3 clinical studies have been completed in collaboration with Bausch + Lomb and Allergan using the CAESM model to screen subjects with dry eye for inclusion to the studies. In each of the three studies approximately 400 subjects with dry eye were randomized to 1% tavilermide or placebo (vehicle) dosed in both eyes, twice a day, for 8 weeks. Data generated from these studies showed small, but significant (p<0.05) treatment effects of 1% tavilermide compared to vehicle in reducing the signs and symptoms of dry eye, in secondary and exploratory endpoints, with excellent safety and tolerability profiles.
Tavilermide 5% Phase 3 Study
In 2020 Mimetogen completed the first Phase 3 environmental study to evaluate the safety and efficacy of 5% tavilermide dosed in both eyes, twice a day with a treatment period of 12 weeks. In the Phase 3 study, approximately 500 subjects with dry eye were randomized 1:1 to 5% tavilermide or placebo (vehicle). The trial demonstrated statistically significant and clinically relevant improvement in the pre-specified primary sign endpoint (corneal fluorescein staining) at 12 weeks, with significant onset of effect observed at 8 weeks. Significant improvements for 5% tavilermide were also observed as early as 2 weeks, and with continued improvement out to 12 weeks, for the pre-specified primary symptom endpoint (ocular dryness) in a meaningful subgroup analysis. 5% tavilermide demonstrated excellent safety and tolerability profiles. This study demonstrated significant improvements in signs and symptoms of dry eye driven by the neurotropic mechanism of action of 5% tavilermide on the ocular surface and establishes 5% tavilermide as a safe and well tolerated ophthalmic product for use in dry eye.
- Meerovitch et. al., Clinical Ophthalmology 2013; 7:1275-1285.