Mimetogen Pharmaceuticals Inc. (“Mimetogen”), a clinical-stage biopharmaceutical company focused on the development of tavilermide, a first-in-class nerve growth factor (NGF) mimetic for the treatment of dry eye disease, today announced that it completed enrollment of its 600-patient MIM-728 Phase 3 clinical trial for tavilermide ophthalmic solution.
The MIM-728 trial is a multicenter, randomized, double-masked, placebo-controlled, parallel-group study comparing the efficacy of 5% tavilermide and 1% tavilermide ophthalmic solutions to vehicle (placebo), each dosed two times a day (BID) for 12 weeks. Subjects who meet initial screening and inclusion/exclusion criteria undergo a two-week run-in period with vehicle. Subjects who continue to meet inclusion/exclusion criteria after the run-in are randomized to receive either tavilermide or vehicle. Change in Eye Dryness Score as measured by the visual analog scale (VAS) and change in total Corneal Fluorescein staining are primary endpoints.
“We are excited with our MIM-728 trial design,” said Karen Meerovitch PhD, Vice President of Clinical Development at Mimetogen. “We are confident that the specific modifications made to the inclusion/exclusion criteria from Mimetogen’s previous trials and the inclusion of the 5% tavilermide dose concentration will increase the likelihood of patient improvement when taking tavilermide”.
“It is encouraging to see Mimetogen pursuing development of tavilermide, a small-molecule peptidomimetic of NGF, with a multifactorial mechanism of action that addresses many underlying pathologies of dry eye disease. Demonstration of a significant improvement in signs and symptoms would represent a major advancement for this novel therapy for dry eye disease,” said Dr. Edward Holland, Professor of Ophthalmology, University of Cincinnati.
Mimetogen also wants to express its sincere appreciation to patients, investigators and CRO for their continued participation and commitment to ensuring patient safety and data integrity during this unprecedented global Covid-19 crisis.
Mimetogen expects that the results from this trial will be available in the last quarter of 2020.
About Tavilermide (MIM-D3)
Tavilermide is a small cyclic peptidomimetic drug that mimics nerve growth factor (NGF). Preclinical studies showed that tavilermide is a partial TrkA receptor agonist, activating and potentiating the effects of NGF, which is an essential growth factor for the health and healing of the ocular surface. Tavilermide is differentiated from other investigational therapies in the dry eye pipeline because it addresses some of the multifactorial mechanisms of DED by facilitating protein secretions from the conjunctival glands which line the inside of the eye-lids that help keep the ocular surface lubricated under normal conditions. Tavilermide is a preservative-free aqueous, sterile ophthalmic solution and has been previously tested in Phase 2 and Phase 3 DED clinical trials, where reproducible safety and efficacy has been demonstrated.
About Dry Eye Disease
Dry eye disease (DED) is a disease of the tears and ocular surface characterized by dysfunction of the lacrimal glands that could lead to poor tear quality or insufficient tear levels due to inadequate production or excessive tear evaporation. If untreated, DED has a negative effect on visual function and patient eye comfort making it more difficult to perform common activities such as reading or using a computer or reading for an extended period of time. DED is a large growing market, with approved treatment options in North America limited to anti-inflammatory medications.