Lenus Therapeutics Announces the Result of Complete Wound Healing on the Index Lesion of the First Subject in an Ongoing Single-Masked Phase 2 Trial with RGN-137 Dermal Gel for Epidermolysis Bullosa

PRINCETON, N.J., Aug 5, 2019 /PRNewswire/ -- Lenus Therapeutics, LLC (the 'Company'), a US-based joint venture between GtreeBNT ('Gtree') and Yuyang DNU ('Yuyang') in Korea, announced that it has confirmed complete wound healing of the index lesion of the first subject enrolled in its ongoing single-masked Phase 2 clinical trial with RGN-137 dermal gel for Epidermolysis Bullosa (EB).

The Company, which is developing a new drug called RGN-137 for the treatment of EB, a rare incurable disease with severe symptoms, announced that the ongoing Phase 2 clinical trial in the US is proceeding well at five hospitals specializing in EB.

EB is a rare hereditary disease where the patients suffer from skin fragility. The skin is easily blistered due to gene mutations in proteins important in epidermal and dermal integrity, resulting in severe pain in both the skin and mucous membranes. There are approximately 500,000 patients worldwide with the US and European countries having approximately 50,000 patients. No specific treatment is available beyond supportive care, such as sterile dressing and antibiotics.

The ongoing clinical trial is a single-masked study where two wounds are selected from each patient with one wound treated with placebo and the other with RGN-137 dermal gel. The design is an open study where the results can be confirmed for each patient in parallel with the clinical progression. "The first patient was enrolled, treated, and then confirmed the effect of complete wound healing in one wound but not in the other," said an official at the Company.

The new drug "RGN-137", which is being developed by the Company, aims to be the first approved product for EB treatment based on its multiple mechanisms of actions, such as promotion of wound healing, cell protection, cell migration, and tissue integrity.

"The achievement of the complete healing in the first enrolled patient is very significant as the upcoming Phase 3 study design will be based on the results of the current ongoing open study. The experiences and findings in the present study will provide the information for defining the clinical study design for the phase 3 study. Thus, RGN-137 will potentially relieve the suffering related to the non-healed wounds of EB pediatric patients," stated an official at the Company.

About Lenus Therapeutics, LLC

Lenus Therapeutics, LLC ('Lenus') is a US joint venture company owned by both GtreeBNT Co., Ltd ('Gtree'), and Yuyang DNU Co., Ltd. specifically to develop RGN-137 in the US, Canada, Europe, Korea, Japan, and Australia for dermal indications. Gtree licensed the rights to RGN-137 from RegeneRx Biopharmaceuticals, Inc. in 2014 and all rights to were assigned to Lenus. Currently, Lenus is conducting a Phase 2 trial in the US for epidermolysis bullosa, a rare disease prior to entering into a Phase 3 trial. For additional information about Lenus, please contact [email protected].

Forward-Looking Statements

Any statements in this press release that are not historical facts are forward-looking statements made under the provisions of the Private Securities Litigation Reform Act of 1995. Any forward-looking statements involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. There can be no assurance that any current or future clinical trials will result in approved products or future value. There can also be no assurance that the Company will apply for an NDA in the future or that if the Company applies for an NDA, that it will be accepted by the FDA and/or that the product candidate will be approved for marketing in the U.S. Any forward-looking statements in this press release represent the Company's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date.  The Company specifically disclaims any obligation to update this information as a result of future events or otherwise, except as required by applicable law.

SOURCE Lenus Therapeutics, LLC