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Inotek Pharmaceuticals Initiates Dosing of MATRx-1, the First Pivotal Phase 3 Clinical Trial of Trabodenoson, a Novel Treatment for Glaucoma

LEXINGTON, Mass.--(BUSINESS WIRE)--

Inotek Pharmaceuticals Corporation (ITEK) (the “Company” or “Inotek”), a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of therapies for ocular diseases, today announced that dosing of patients has commenced in MATRx-1, the first pivotal Phase 3 trial of trabodenoson for the treatment of glaucoma. Trabodenoson, the Company’s lead clinical candidate, is a first-in-class selective adenosine mimetic under investigation for reduction of intraocular pressure.

MATRx-1 is a Phase 3 randomized, double-masked, placebo-controlled trial of trabodenoson in approximately 335 patients diagnosed with primary open-angle glaucoma (POAG) or ocular hypertension (OHT). MATRx-1 will assess the efficacy, safety and tolerability of trabodenoson over three months of treatment. The primary endpoint will be the reduction of intraocular pressure (IOP) as compared to the placebo treatment arm. In addition, the study will contain a timolol 0.5% arm to validate the sensitivity of the patient population. Intraocular pressure (IOP) will be measured at four timepoints during the day, 8AM, 10AM, 12PM, and 4PM on days 14, 28, 42, and 84. Three doses of trabodenoson will be administered: 1000 mcg once daily, 1500 mcg twice daily, and 2000 mcg once daily. These doses were selected to assess efficacy in intraocular pressure lowering, while maintaining the tolerability and safety profile observed in Phase 2 trials. The trial will enroll patients with IOP greater than or equal to 24 mm Hg and less...


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