Timber Pharmaceuticals Surpasses 60% Enrollment for Pivotal Phase 3 Clinical Trial

Clinical stage biopharmaceutical company, Timber Pharmaceuticals (NYSE American: TMBR), has provided a business update and announced financial results for the first quarter of 2023.

Timber also announced it has enrolled over 60% of patients in its pivotal TMB-001 Phase 3 ASCEND clinical trial. TMB-001 has been awarded Breakthrough and Fast Track designations by the FDA. 


Timber’s pivotal trial is evaluating TMB-001, a topical isotretinoin formulated using the company’s patented IPEG™ delivery system, for the treatment of X-linked recessive ichthyosis (XLRI) and autosomal recessive congenital ichthyosis (ARCI).

The trial is expected to enroll more than 140 patients with moderate to severe CI at leading research centers in the U.S., Canada, Italy, France, and Germany.

In March 2023, a sub-analysis of data from the company’s Phase 2b CONTROL trial was published in Clinical and Experimental Dermatology, showing that treatment with TMB-001 could be effective regardless of the subtype of congenital ichthyosis (CI) studied.In February 2023, the European Commission (EC) granted orphan designation for TMB-001 for the treatment of XLRI. The EC previously granted TMB-001 orphan designation for the treatment of ARCI in October 2022.

As of March 31, 2023, Timber had approximately $5.2 million in cash and approximately 3.0 million shares of common stock outstanding.

About Timber Pharmaceuticals

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 currently focused on developing non-systemic treatments for rare dermatologic diseases including congenital ichthyosis (CI) and sclerotic skin diseases. For more information, please visit https://www.timberpharma.com/.


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Timber Pharmaceuticals Surpasses 60% Enrollment for Pivotal Phase 3 Clinical Trial

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