Hallux Release: Clinical Research Study In Toenail Fungus Open For Enrollment In Mesa, Arizona

LAGUNA HILLS, Calif.--(BUSINESS WIRE)--Hallux, Incorporated, a pharmaceutical company focused on developing a new treatment for toenail fungus (onychomycosis), is now accepting patients into a new clinical research study led by Dr. Lewis Freed at the OrthoArizona East Valley Foot and Ankle Clinic in Mesa, Arizona.

“Results from the pilot studies were encouraging. We are excited about the potential of this targeted, localized drug delivery technique and the ability to leverage the power of terbinafine without the concerns of systemic therapy.”

The trial will test a new method of delivering terbinafine, a known drug for treating toenail fungus, directly to the site of the infection in the toe. Qualified trial participants will receive the investigational medication at no cost and will be monitored for 48 weeks. You can schedule a free evaluation by calling 480-433-0281 or emailing toenail@prgresearch.com.

Toenail fungus, clinically known as onychomycosis, is characterized by toes that become yellow, thick, cracked, and crusty. This is caused by fungus that gets under the toenail, into the nail bed, and then begins to spread, causing the nail to become yellow, thick, and ugly.

Dr. Freed said, “Toenail fungus is common. Over 35 million Americans have this disease which makes their toes look ugly and unhealthy. In an area like Phoenix, where the weather is good and we can wear sandals and open-toed shoes year around, fungus-infested yellow toenails do not look very good. Onychomycosis is currently treated using oral drugs that can cause liver toxicity and other systemic safety issues or topical products where very little of the drug actually gets through the hard nail plate to the toenail bed where the fungus resides and thrives. In this study, we will deliver the drug directly to the nail bed and plate where the fungus is located.”

Dr. Freed, a noted researcher and clinician, is the principal investigator of the HTS-519 Micro-Insert developed by Hallux, a pharmaceutical company focused on the treatment of onychomycosis. Dr. Freed will be evaluating candidates and treating patients in his Mesa-area office.

Henk-André Kroon, MD, MBA, Hallux Executive VP & Chief Medical Officer, said, “We are thankful to have a foot and ankle expert of Dr. Freed’s caliber participating with us to evaluate this exciting new method of treating toenail fungus that affects so many people. Our goal in treating the disease directly in the toenail bed is to provide a safe way of delivering the maximum amount of fungus-killing medication to the toenail bed without the side-effects of oral medications – pills.”

Dr. Freed added, “Results from the pilot studies were encouraging. We are excited about the potential of this targeted, localized drug delivery technique and the ability to leverage the power of terbinafine without the concerns of systemic therapy.”

About Dr. Lewis Freed, DPM

Dr. Freed is a Phoenix-area podiatrist and the senior partner in OrthoArizona East Valley Foot & Ankle Specialists. He has offices in Mesa, Gilbert, Scottsdale, Queen Creek, and Globe. Dr. Freed is a Fellow of the American College of Foot and Ankle Surgeons and past-president of the Arizona Podiatric Medicine Association. In addition, he is a frequent lecturer on foot and ankle disease and injuries and has worked with numerous technology companies to develop procedures and products that are used to treat thousands of people each year. His phone number is 480-433-0281 and the clinical research website is www.prgresearch.com.

About Onychomycosis

Onychomycosis is a fungal infection of the nail bed and plate caused predominately by dermatophyte fungi. The infection typically begins as a small white or yellow spot beneath the nail, causing nail discoloration, thickening, and splitting of the nail and detachment of the nail plate from the nail bed. The damage to the nails can result in pain and difficulty walking, wearing shoes, and social embarrassment due to the unsightly appearance of the nails. Untreated onychomycosis may lead to other serious complications for diabetics and other immune-compromised patients and patients with poor circulation.

Topical products have difficulty penetrating the nail plate and reaching the nail bed at sufficient concentrations, while drug interactions and safety concerns have limited oral treatments for onychomycosis. About 35 million people in the U.S. have onychomycosis but treatments have been limited and the infection undertreated with 85% of patients not treated.

About Hallux

Hallux is a clinical-stage pharmaceutical company focused on developing a new dosage form and route of administration for treating onychomycosis (toenail fungus). Hallux’s goal is to provide high effectiveness and safety for chronic onychomycosis patients. The company’s flagship technology, the HTS-519 subungual Micro-Insert, is biodegradable and delivers high concentrations of terbinafine hydrochloride directly and selectively to the site of the infection with minimal exposure of the body to the drug. You can contact Hallux at www.HalluxInc.com.