Mimetogen Pharmaceuticals Inc. (“Mimetogen”) today announced positive top line data from its second clinical study (Study Designation MIM-725) with MIM-D3, its lead drug for the treatment of dry eye syndrome. The trial demonstrated significant improvements in both signs and symptoms with 1% MIM-D3 versus placebo, together with excellent safety, comfort and tolerability profiles.
Mimetogen has completed its initial analysis of the data and met with the FDA in order to confirm the outstanding requirements for the remainder of the clinical development plan. “These clinical results further support the data generated in our first clinical trial (Study Designation MIM-724) and are promising for the use of MIM-D3 for the treatment of dry eye syndrome. Following our meeting with the FDA, we have begun preparations for the next clinical and non-clinical studies”, said Garth Cumberlidge, President and CEO of Mimetogen, adding: “MIM-D3, a novel growth factor mimetic, represents a potential first-in-class therapy for the estimated $3 billion US market”.
The 403-patient study (ClinicalTrials.gov Identifier: NCT01960010) utilized Ora’s Controlled Adverse Environment (CAESM) chamber to measure dry eye patients' ability to withstand a stressful drying environment on the eye, and patient diaries to measure the severity of their dry eye symptoms over the course of the study. In the study, MIM-D3 successfully demonstrated superiority over placebo in the pre-specified endpoints of both central and total corneal fluorescein staining (change from pre to post CAE) at week 8 (p = 0.0134 and p = 0.0500, respectively) as measured via the Ora Calibra™ Scale. MIM-D3 also significantly improved common vision-related function symptoms of dry eye disease as measured via the OSDI® questionnaire. The mean blurred vision, reading and watching TV scores were lower in the MIM-D3 group than in the respective placebo groups at week 8 (p = 0.0393, p = 0.0433 and p = 0.0046, respectively).
MIM-D3 was comfortable, well tolerated and there were no unexpected or serious ocular adverse events. The most commonly reported ocular adverse events were reduction of visual acuity (MIM-D3, 3%; Placebo, 3%); instillation site pain (MIM-D3 1%; placebo, 1.5%) and eye irritation (MIM-D3, 0%; Placebo, 1.5%). All adverse ocular events were mild and transient in nature.
“Demonstrating significant improvements in central corneal staining in both Phase II and III studies is a very encouraging finding for patients suffering from dry eye, as this is the region most apt to cause the visual fluctuations that are common in this disease” says Dr Edward Holland, Director of Cornea Services at Cincinnati Eye Institute. “The improvements seen with patient-reported blurriness and poor vision in this study are consistent with the findings on central corneal staining and suggest that MIM-D3 may be an important therapy for addressing one of the key issues in dry eye.”
George Ousler, VP of Dry Eye at Ora, Inc., indicated that “MIM-D3 is differentiated from other investigational therapies in the dry eye pipeline because it addresses an underlying cause of this disease and works upstream of the resultant inflammation.”
About Dry Eye Syndrome
Dry eye occurs when the eye does not produce enough tears, or when the tears are not of the correct consistency and evaporate too quickly. Inflammation of the surface of the eye may also occur. If left untreated, the condition can lead to pain, ulcers, or scars on the cornea, and some loss of vision, although permanent loss of vision from dry eye is uncommon. Dry eye can also have a significant impact on quality of life, making it more difficult to perform activities such as using a computer or reading for an extended period of time.
About Mimetogen Pharmaceuticals
Mimetogen Pharmaceuticals Inc. is a private company focused on developing the use of peptidomimetics as a novel approach to treating ophthalmic diseases with high unmet medical needs. The underlying technology was developed at McGill University and the Lady Davis Institute for Medical Research in Montreal. The company is currently developing novel therapeutic approaches for indications including dry eye disease, glaucoma and other degenerative diseases of the retina.
About Ora, Inc.
Ora is the world’s leading independent, full-service ophthalmic CRO and product development firm with offices in the United States and Japan. Over the past 30 years, we helped our clients earn 37 FDA approvals. Ora’s Dry Eye System addresses the challenges of evaluating treatments for dry eye disease, such as environmental and seasonal variability, through a combination of scientific and operational methods. Ora’s Dry Eye System integrates highly trained site-level operations support, mobile and stationary CAESM chambers, validated Ora Calibra™ Scales and a subject recruiting program that allows for high-density block enrollment across Ora’s network of clinical investigator sites (OraNET).