Micrograph of keloid. Credit: Department of Pathology, Calicut Medical College.

miRagen Therapeutics has commenced a Phase ll clinical trial to investigate MRG-201 to treat patients with a predisposition for keloid formation.

The double-blinded, randomised trial aims to enrol around 12 patients who are historically predisposed to keloid formation after trauma to the skin at several sites in the US.

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Under the trial, the patients will receive small, matching excisional wounds that will be sutured and then injected with either MRG-201 or placebo.

This process is set to allow the patients to take control of their own situation, thereby increasing the statistical powering of the trial.

The trial will monitor the lesions for up to 12 months to determine presence or absence of keloid formation.

“The lesions can be disfiguring and are often itchy and painful, which can lead to decreased quality of life for patients.”

miRagen Therapeutics president and CEO William Marshall said: “We believe advancing MRG-201 into a Phase ll clinical trial in subjects with a predisposition for keloid formation is an exciting opportunity to build on the Phase l data in induced cutaneous fibrosis, where MRG-201 reduced scar tissue deposition in healthy human volunteers.

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“Keloids are benign growths that form when scar tissue grows excessively after skin is injured.

“The lesions can be disfiguring and are often itchy and painful, which can lead to decreased quality of life for patients.”

miRagen has developed the MRG-201 to mimic the activity of microRNA-29 and decrease the expression of several proteins involved in fibrous scar formation.

The company believes that MRG-201 could provide support for the therapeutic approach in various types of pathological fibrotic conditions.