RegeneRx JV Updates RGN-259 Regulatory Progress for Dry Eye Syndrome
RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) provided an update on its joint venture, ReGenTree LLC, regarding progress towards a pre-BLA meeting with the FDA for RGN-259, targeting dry eye syndrome. The company is collaborating with a 3rd party FDA consulting firm to complete regulatory analysis and plans to submit a meeting request by Q3 2021. ReGenTree is optimistic about the meeting's approval based on clinical data and a regulatory package. If granted, a briefing document will be provided to the FDA 30 days before the meeting.
- Progress towards submitting a pre-BLA meeting request with the FDA for RGN-259.
- Gap analysis and regulatory work are reportedly on schedule.
- Company's confidence in the clinical data and regulatory package aiding in securing the pre-BLA meeting.
- No guarantees that the pre-BLA meeting will be granted or that any clinical trial will be successful.
ROCKVILLE, Md., July 14, 2021 /PRNewswire/ -- RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) ("RegeneRx"), a clinical-stage drug development company focused on tissue protection, repair and regeneration has released an update from its U.S. joint venture, ReGenTree LLC, regarding its progress and prospects of a pre-BLA (Biologics License Application) meeting with FDA.
As previously reported, ReGenTree is working with a 3rd party FDA consulting firm to complete a regulatory gap analysis and explore the prospects of a pre-BLA meeting. This includes a review of clinical studies, non-clinical studies, CMC requirements and previous meeting minutes between ReGenTree and FDA. The company plans to submit a pre-BLA meeting request to FDA within the third quarter of this year along with questions to be discussed at the meeting.
According to a ReGenTree official, the gap analysis is proceeding well and the company believes there is a possibility of a pre-BLA meeting being granted based on its clinical data and regulatory package, within the targeted timeline. ReGenTree intends to officially confirm when the meeting request is granted by FDA.
The purpose of a pre-BLA meeting is to discuss with FDA the format, content, and acceptability of the anticipated BLA application. If the meeting requested is granted, an applicant must provide the briefing document to the agency no later than 30 days before the scheduled date of the meeting. According to FDA's guidance regarding formal meetings, when the applicant submits a meeting request for the pre-BLA meeting, FDA may either deny the pre-BLA meeting or change it to a different type of meeting if either the provided information is premature for the stage of product development or the meeting package does not provide an adequate basis for the meeting discussion.
"We are pleased that the gap analysis and regulatory work is on schedule and we look forward to submitting the pre-BLA meeting request this quarter. We will update our investors and stockholders as soon as we receive a response to our meeting request or if there are any material changes to our current timetable or plans," stated J.J. Finkelstein, RegeneRx's president and chief executive.
About RegeneRx Biopharmaceuticals, Inc.
RegeneRx is focused on the development of novel therapeutic peptides, including Thymosin beta 4 (Tβ4) and its constituent fragments, for tissue and organ protection, repair, and regeneration. RegeneRx currently has three drug candidates in clinical development for ophthalmic, cardiac/neuro and dermal indications, four active strategic licensing agreements in the U.S., China, and Pan Asia (Korea, Japan, and Australia, among others), and the EU, and has patents and patent applications covering its products in many countries throughout the world.
About ReGenTree, LLC
ReGenTree is a U.S. joint venture company owned by GtreeBNT Co., Ltd, and RegeneRx Biopharmaceuticals, Inc., specifically to develop RGN-259 in both the U.S. and Canada for ophthalmic indications. ReGenTree licensed the rights to RGN-259 from RegeneRx in 2015. Thus far, ReGenTree has sponsored three Phase 3 studies in the U.S. for dry eye, which are ARISE-1 (Phase 2b/3), ARISE-2 (Phase 3), and the recently completed ARISE-3 (Phase 3) for dry eye. In addition to dry eye, the Company completed a Phase 3 study (SEER-1) for neurotrophic keratopathy (NK), an orphan indication in ophthalmology. For additional information about ReGenTree, please visit www.regentreellc.com.
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. Forward-looking statements in this press release include, but are not limited to, information on phase 3 trial results, competitive products, statements from us, or our U.S. joint venture partner, GtreeBNT, status of clinical trials and regulatory submissions, the development and value of our drug candidates, and the use of our drug candidates to treat various conditions. All forward-looking statements are expectations and estimates based upon information obtained and/or calculated by the Company or its joint venture partner and its affiliates at this time and are subject to change. Moreover, there is no guarantee any clinical trial will be successful or confirm previous clinical results. Please view these and other risks described in the Company's filings with the Securities and Exchange Commission ("SEC"), including those identified in the "Risk Factors" section of the annual report on Form 10-K for the year ended December 31, 2020, and subsequent quarterly reports filed on Form 10-Q, as well as other filings it makes with the SEC. Any forward-looking statements in this shareholder letter 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.
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SOURCE RegeneRx Biopharmaceuticals, Inc.
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