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Timber Pharmaceuticals Announces 50% Enrollment in Phase 2b CONTROL Study in Congenital Ichthyosis

– Study is Evaluating TMB-001 (Topical Isotretinoin) in Subtypes of Rare Genetic Keratinization Disorder 

– Company Awarded Final Tranche of $1.5 million FDA Orphan Products Clinical Trials Grant   

WOODCLIFF LAKE, NJ – (NewMediaWire) – March 15, 2021 – Timber Pharmaceuticals, Inc. (“Timber” or the “Company”) (NYSE American: TMBR), a biopharmaceutical company focused on the development and commercialization of treatments for rare and orphan dermatologic diseases, today announced that 50 percent of patients in the Phase 2b CONTROL study evaluating TMB-001 (topical isotretinoin) in patients with moderate to severe congenital ichthyosis (CI) have now been randomized. The Company also announced it has been awarded the final tranche of a $1.5 million grant from the U.S. Food & Drug Administration (FDA) Office of Orphan Products Development (OOPD) Orphan Products Clinical Trials Grants Program based on clinical milestones in the development of TMB-001.

“There are many rare dermatologic diseases that do not have any approved therapies and we are committed to advancing research focused on novel topical treatments that may enable targeted delivery to the epidermis and dermis while minimizing systemic absorption,” said Alan Mendelsohn, M.D., Chief Medical Officer of Timber. “People living with CI face many significant challenges in everyday life, not just physically but also with psychological well-being and self-esteem. Our success with enrolling the CONTROL study is a testament to the tremendous need for new treatment options. We are grateful to the patients who are participating and organizations like the Foundation for Ichthyosis & Related Skin Types (FIRST) that are helping raise awareness of this study amidst all the difficulties of the COVID-19 pandemic.” 

CI is a group of rare genetic keratinization disorders that leads to dry, thickened, and scaling skin. People living with CI may have limited range of motion, chronic itching, an inability to sweat normally, high risk of secondary infections, and impaired eyesight or hearing. Moderate to severe subtypes of CI, including X-linked ichthyosis and lamellar ichthyosis, affect about 80,000 people in the U.S. and more than 1.5 million globally.

The Phase 2b CONTROL study is a randomized, parallel, double-blind, vehicle-controlled study to assess the efficacy and safety of two concentrations of TMB-001 for the treatment of moderate to severe subtypes of CI. The study is targeting enrollment of 45 patients aged nine years old and older. 

“We hope that by formulating isotretinoin into a proprietary topical we might be able to allow for chronic use on up to 90 percent of body surface area without eliciting the side effect profile of systemic isotretinoin preparations,” added Dr. Mendelsohn. 

For more information about the Phase 2b CONTROL study, visit https://ichthyosistrial.com/

About Timber Pharmaceuticals, Inc.

Timber Pharmaceuticals, Inc. is a 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), facial angiofibromas (FAs) in tuberous sclerosis complex (TSC), and scleroderma. 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 Form 10-Q filed on August 18, 2020 and its other filings 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 
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

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