Turn Therapeutics Reports Interim Analysis Findings and Adaptive Optimization Strategy from Phase 2 GX-03 Trial in Moderate-to-Severe Atopic Dermatitis
92.6% of GX-03-treated subjects achieved a 50% reduction in eczema severity in 4 weeks (
Interim analysis informed refinement of enrollment criteria, endpoint hierarchy, and overall trial optimization strategy
No treatment-related serious adverse events observed in either treatment group; no treatment-related tolerability issues or discontinuations reported during the interim analysis period
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The interim review was conducted under the study’s established independent data monitoring committee (“IDMC”) framework. Upon the advice of the Company’s independent statisticians and clinical and regulatory advisors, including former
Within the completed interim cohort, 92.6% of GX-03-treated subjects achieved at least a 50% reduction in overall eczema severity within 4 weeks (
There were no observed or reported treatment-related serious adverse events during the interim analysis period, no treatment-related tolerability concerns reported by subjects, and no treatment-related discontinuations, with GX-03 continuing to demonstrate a favorable safety and tolerability profile.
“What became increasingly apparent during the interim review was the speed with which responses emerged,” said
Skin and inflammatory disease expert Dr.
The Company is now strategically utilizing the interim findings to optimize the remainder of the trial, including refinement of enrollment criteria to better control for baseline
About GX-03
GX-03 is an investigational extended-release topical formulation designed to provide sustained localized exposure to polyhexanide at the skin surface. GX-03 is being developed as a targeted, localized therapy for inflammatory skin diseases.
About Turn Therapeutics
Turn Therapeutics is a clinical-stage biotechnology company focused on developing targeted, localized therapies for inflammatory and infectious skin diseases.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, contained in this press release are forward-looking statements, including statements regarding clinical development plans, optimization of enrollment criteria and endpoints, interpretation of interim clinical observations, expected trial timing, regulatory interactions, and the therapeutic potential of GX-03. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “suggest,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Turn’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict, including risks related to the success of development programs, the availability of additional financing, and the Company’s ability to execute its strategic plan. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. For a further discussion of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Turn Therapeutics in general, see the risk disclosures in the Company’s filings with the SEC. All such forward-looking statements speak only as of the date they are made, and Turn undertakes no obligation to update or revise these statements, whether as a result of new information, future events, or otherwise.
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Investor Relations / Media Contact
Sasha Damouni
Damouni Group LLC
Sasha@damounigroup.com
Source: Turn Therapeutics Inc.