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news.Kala Pharmaceuticals has announced the initiation of two clinical trials with its nanotechnology-based loteprednol etabonate MPP (LE-MPP) program, KPI-121.
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Kala has initiated dosing in its Phase III trial (KPI-121-C-001) to evaluate the safety and efficacy of LE-MPP in managing inflammation and pain associated with cataract surgery. In addition, Kala has initiated a Phase II trial (KPI-121-C-002) with KPI-121 to investigate the safety and efficacy of low-dose LE-MPP in patients with dry eye disease.
Kala president and CEO Guillaume Pfefer said that the company is pleased to advance the clinical development of KPI-121, the first product candidate leveraging Kala’s proprietary MPP delivery platform.
"Our goal is to leverage the power of our Mucus Penetrating Particle technology to develop new and better treatments for multiple ocular diseases. We believe that nanotechnology has the potential to transform the treatment of eye diseases in much the same way it has already transformed other therapeutic areas," Pfefer added.
Kala’s proprietary MPP nanotechnology platform allows therapeutic agents to pass through the mucus layer of the tear film, facilitating penetration into deeper tissues of the eye, including the cornea, aqueous humor and retina.
In a Phase III, double-masked, randomized, controlled trial, Kala will investigate the efficacy and safety of 1% LE-MPP dosed two times daily and 0.25% LE-MPP dosed four times daily as compared to placebo in subjects who have undergone cataract surgery and who require treatment of postoperative anterior ocular inflammation. Kala aims to enroll approximately 375 patients in 25 centers in the US.
In preclinical studies, LE-MPP demonstrated a superior pharmacokinetics profile in target tissues compared to currently marketed loteprednol etabonate products. In head-to-head preclinical studies, LE-MPP delivered significantly greater levels of drug to the aqueous humor, as well as the cornea, conjunctiva and retina than either Lotemax® Suspension or Lotemax® Gel, with similar dosing regimens.
In a Phase II, double-masked, randomized, controlled study of LE-MPP, Kala will investigate the safety and efficacy of 0.25% LE-MPP compared to vehicle dosed four times daily in subjects who have a documented clinical diagnosis of dry eye disease. Kala aims to enroll approximately 150 patients in up to 10 centers in the U.S.
Later in 2014, Kala will initiate two additional clinical trials with LE-MPP. The first is a Phase II trial with 0.25% LE-MPP versus vehicle dosed four times daily in inflammatory meibomian gland disease (posterior blepharitis).
The second is an exploratory trial with 1% LE-MPP and 0.25% LE-MPP dosed four times daily in subjects diagnosed with diabetic macular edema or retinal vein occlusion to evaluate the ability to treat retinal diseases via topical administration. The company continues to advance its novel, small molecule receptor tyrosine kinase inhibitor (RTKi)-MPP program towards a development candidate selection.