- Company announces positive clinical data of FDA-Designated Breakthrough Therapy TMB-001 demonstrating safety, efficacy and quality of life improvements in congenital ichthyosis patients will be presented in seven abstracts -
BASKING RIDGE, NJ, Aug. 29, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire – Timber Pharmaceuticals, Inc. ("Timber" or the “Company”) (NYSE American: TMBR), a clinical-stage biopharmaceutical company focused on the development and commercialization of treatments for rare and orphan dermatologic diseases, today announced that seven abstracts detailing positive clinical data from the completed Phase 2b CONTROL study of TMB-001 were accepted for e-poster presentation at the 31st European Academy of Dermatology and Venerology (EADV) Congress, which will be held in Milan, Italy and virtually from September 7-10, 2022. TMB-001 is a topical isotretinoin formulation in development based on the Company’s patented IPEG™ delivery system for the treatment of moderate to severe forms of congenital ichthyosis (CI), a group of rare genetic keratinization disorders that lead to dry, thickened, and scaling skin. In May 2022, the FDA designated TMB-001 as a breakthrough therapy for the treatment of CI.
Details of the e-poster presentations at the 31st EADV Congress are as follows:
Poster Presentations
Title: Characteristics of patients with congenital ichthyosis achieving greater than 50% reduction in Visual Index for Ichthyosis Severity scaling score relative to baseline after topical isotretinoin formulation TMB-001: CONTROL study results
Presenting Author: Christopher G. Bunick, MD, PhD, Yale University School of Medicine
Poster Number: P1003
Title: Change in quality-of-life measurements after treatment with topical isotretinoin formulation (TMB-001) at 12 weeks in patients with congenital ichthyosis at baseline: Phase 2b CONTROL study results
Presenting Author: Leslie Castelo-Soccio, MD, PhD, Perelman School of Medicine, University of Pennsylvania and Children’s Hospital of Philadelphia
Poster Number: P1004
Title: Effect of topical isotretinoin formulation (TMB-001) concentration on incidence of local skin reactions in patients with congenital ichthyosis: Phase 2b CONTROL study results
Presenting Author: Joyce M. C. Teng, MD, PhD, School of Medicine, Stanford University
Poster Number: P1005
Title: Effect of topical isotretinoin (TMB-001) treatment on laboratory parameters in patients with congenital ichthyosis: CONTROL study results
Presenting Author: Alan M. Mendelsohn, MD, Timber Pharmaceuticals
Poster Number: P1006
Title: Efficacy and safety of topical isotretinoin (TMB-001) treatment in patients with X-linked recessive or autosomal recessive lamellar congenital ichthyosis: CONTROL study results
Presenting Author: Joyce M. C. Teng, MD, PhD, School of Medicine, Stanford University
Poster Number: P1007
Title: Efficacy of topical isotretinoin TMB-001 in children and adults with congenital ichthyosis: Phase 2b CONTROL study results
Presenting Author: Joyce M. C. Teng, MD, PhD, School of Medicine, Stanford University
Poster Number: P1008
Title: Congenital ichthyosis subtype analysis of primary efficacy of a novel topical isotretinoin formulation (TMB-001): Results from the Phase 2b CONTROL study in patients with recessive X-linked and autosomal recessive lamellar congenital ichthyosis
Presenting Author: Dédée F. Murrell, MA, BMBCh, FAAD, MD, FACD, School of Medicine, University of New South Wales
Poster Number: P1009
About Timber Pharmaceuticals, Inc.
Timber Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of treatments for rare and orphan dermatologic diseases. The Company's investigational therapies have proven mechanisms-of-action backed by decades of clinical experience and well-established CMC (chemistry, manufacturing, and control) and safety profiles. The Company is initially focused on developing non-systemic treatments for rare dermatologic diseases including congenital ichthyosis (CI) and other sclerotic skin diseases. For more information, visit www.timberpharma.com.
Forward-Looking Statements
This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company's product development, clinical and regulatory timelines, market opportunity, competitive position, intellectual property rights, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management's current beliefs and assumptions.
These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential, "predict," "project," "should," "would" and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company's Annual Report on Form 10-K for the year ended December 31, 2021 as well as other documents filed by the Company from time to time thereafter with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
For more information, contact:
Timber Pharmaceuticals, Inc.
John Koconis
Chairman and Chief Executive Officer
jkoconis@timberpharma.com
Investor Relations:
Stephanie Prince
PCG Advisory
(646) 863-6341
sprince@pcgadvisory.com
Media Relations:
Adam Daley
Berry & Company Public Relations
(212) 253-8881
adaley@berrypr.com
