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Mimetogen Announces Initiation of a Phase 3 Clinical Trial with MIM-D3

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Mimetogen Pharmaceuticals Inc. has announced that the initial patients have been enrolled in the company's first pivotal Phase 3 clinical study of MIM-D3 ophthalmic solution for the treatment of dry eye syndrome.

MIM-D3 is the first in a class of molecules called TrkA agonists. MIM-D3 stimulates the production of mucin, which plays a critical role in the protection and overall health of the ocular surface.

Mucins are essential for lubrication; the removal of allergen, pathogens, and debris; and corneal epithelial healing to reduce ocular surface damage.

In addition, MIM-D3 may have additional benefits than currently available dry eye therapies, including the potential to improve neural function, which may improve corneal sensitivity and integrity.

The pivotal trial will further evaluate the safety and efficacy of MIM-D3 in the treatment of dry eye syndrome. Approximately 400 patients will be randomized to receive 1% MIM-D3 ophthalmic solution or placebo twice daily over an 8 week period.

The primary endpoints of the study are corneal fluorescein staining score in the CAESM and ocular dryness. The safety and comfort of MIM-D3 compared to placebo will also be evaluated.

"It is very exciting to see MIM-D3 entering Phase 3 clinical trials for dry eye," says Eric Donnenfeld, MD., of Ophthalmic Consultants of Long Island. "This drug has a unique mechanism with a broad spectrum of effects on the ocular surface that should be of benefit to a wide range of dry eye patients. Dry eye is an extremely common condition that continues to grow as the population ages. Current treatments have limited effectiveness for many patients and there is an increasing need for new therapies for dry eye. With its novel mechanism of action MIM-D3 could provide an exciting option for the treatment of dry eye."

"This pivotal Phase 3 study aims to build upon the positive results observed in the Phase 2 dry eye trial, which demonstrated significant improvements in both signs and symptoms after 14 and 28 days of dosing," said Garth Cumberlidge, PhD, Chief Executive Officer.

"The commencement of patient enrollment in our Phase 3 trial represents yet another significant milestone for Mimetogen on the road to our ultimate goal of making this novel therapy available to millions of dry eye patients."

“We look forward to confirming the therapeutic potential of MIM-D3 which targets an underlying cause of dry eye through a novel mechanism,” said George Ousler, Vice President of Dry Eye at Ora, Inc. “MIM-D3 will be studied using Ora’s Dry Eye System which addresses the challenges of studying dry eye disease, such as environmental and seasonal variability, through a combination of scientific and operational methods."

Bausch + Lomb, the global eye health company, and Mimetogen Pharmaceuticals Inc. previously announced that Bausch + Lomb has acquired an option to license MIM-D3 for dry eye.

Should Bausch + Lomb choose to pursue development based on the Phase 3 study results, the company will assume all development responsibilities and costs, and also will pay development milestones, sales milestones and royalty fees to Mimetogen.