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Timber Pharmaceuticals (NYSE American: TMBR) Granted Orphan Drug Designation in Europe for TMB-001

Timber Pharmaceuticals, Inc. (NYSE American: TMBR) is engaged as a clinical-stage biopharmaceutical company, which is focused on the development and commercialization of treatments for rare and orphan dermatologic diseases. Shares of the biopharma company are soaring 59% through early trading on Friday, February 24, 2023. Over the past three months, Timber Pharmaceuticals has seen average daily volume of 105,490 shares. However, volume of 47 million shares or dollar volume of around $143.35 million, has already exchanged hands through early trading.

Shares of Timber Pharmaceuticals are rallying after the company announced the European Commission has granted orphan drug designation for TMB-001 for the treatment of X-linked recessive ichthyosis (XLRI). The commission had previously granted Timber with an additional orphan drug designation for TMB-001 for the treatment of autosomal recessive congenital ichthyosis (ARCI).

Timber Pharmaceuticals formulated TMB-001 as a topical isotretinoin using its patented IPEG delivery system, in order to treat congenital ichthyosis (CI). CI is a grouping of rare genetic keratinization disorders, which can lead to dry, thickening and scaling skin.

TMB-001 is currently undergoing a pivotal Phase 3 ASCEND clinical trial to test the drug candidate’s efficacy, pharmacokinetics, and safety. The trial is taking place at research centers in the U.S., Canada, Italy, France and Germany. Furthermore, the clinical trial is focused on 142 patients with ages of six years and above with moderate-to-severe CI.

“We are pleased to receive an additional orphan drug designation in Europe for the treatment of XLRI as we continue to make steady progress with our global Phase 3 clinical trial,” said John Koconis, Chairman and Chief Executive Officer of Timber. “These orphan drug designations underscore the significant unmet needs in congenital ichthyosis (CI), which can lead to a limited range of motion, chronic itching, an inability to sweat normally, high risk of secondary infections, and impaired eyesight or hearing. We believe the targeted delivery of therapies to the epidermis and dermis may be able to minimize systemic absorption and we are committed to bringing a potential new treatment option to this rare disease community.”

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