Timber Prescription drugs

– Business making ready to dose to start with sufferers in pivotal Stage 3 ASCEND medical demo –

BASKING RIDGE, NJ, Might 31, 2022 (Globe NEWSWIRE) — by using NewMediaWire – Timber Prescribed drugs, Inc. (“Timber” or the “Company”) (NYSE American: TMBR), a medical-phase biopharmaceutical organization concentrated on the improvement and commercialization of therapies for scarce and orphan dermatologic diseases, currently declared that the U.S. Food and Drug Administration (Food and drug administration) has granted Breakthrough Therapy designation to TMB-001, a topical isotretinoin formulated employing the Company’s patented IPEG™ shipping and delivery process, for the treatment of congenital ichthyosis (CI).

“This is a important instant for individuals who are residing with CI, their people and caregivers, and clinicians and researchers who have been working for a long time to discover new therapy alternatives for this debilitating situation,” claimed John Koconis, Chairman and Chief Govt Officer of Timber. “A Breakthrough Therapy designation is no small achievement. Through 50 percent of FDA’s 2022 fiscal year, more breakthrough apps have been turned down by Fda or withdrawn (16), than have been granted (9). I am proud of our group for demonstrating the probable of TMB-001 in our Phase 2b system, and we are speedily pushing forward with a pivotal Phase 3 medical demo.”

Breakthrough Therapy designation is a process designed to expedite the progress and assessment of medications that are meant to handle major or everyday living-threatening conditions. Preliminary clinical proof ought to suggest that the drug may possibly show significant enhancement more than accessible remedy on a clinically substantial endpoint.

Timber is building TMB-001 for the treatment method of reasonable to extreme kinds of CI, such as X-linked recessive ichthyosis (XRI) and autosomal recessive congenital ichthyosis lamellar ichthyosis (ARCI-LI). CI is a team of uncommon genetic keratinization problems that lead to dry, thickened, and scaling skin. In sufferers with XRI and ARCI-LI, cutaneous manifestations include huge, dim scaling through the overall body.

In the Period 2b Command analyze, treatment method with TMB-001 demonstrated a clinically significant reduction in qualified and all round severity of CI alongside with a favorable basic safety profile. A sub-examination of the study presented at the American Academy of Dermatology (AAD) 2022 Once-a-year Conference confirmed sufferers achieved treatment method accomplishment with TMB-001 regardless of the subtype of CI.

Timber has initiated the pivotal Section 3 ASCEND medical demo to even more investigate the efficacy and security of TMB-001 for the procedure of CI at foremost exploration facilities in the U.S., Canada, Italy, France, and Germany and is expecting to dose the 1st patients in June 2022. The ASCEND trial will examine the efficacy, pharmacokinetics and security of TMB-001 .05% in 142 people with moderate to significant CI.

About Timber Prescribed drugs, Inc.

Timber Pharmaceuticals, Inc. is a medical-stage biopharmaceutical organization centered on the advancement and commercialization of remedies for exceptional and orphan dermatologic disorders. The Firm’s investigational therapies have established mechanisms-of-motion backed by a long time of scientific expertise and nicely-recognized CMC (chemistry, production, and management) and protection profiles. The Business is to begin with targeted on acquiring non-systemic treatments for scarce dermatologic diseases such as congenital ichthyosis (CI), facial angiofibromas (FAs) in tuberous sclerosis complex (TSC), and other sclerotic pores and skin health conditions. For more information, go to www.timberpharma.com.

Ahead-Looking Statements

This push launch contains certain ahead-searching statements within just the which means of Part 27A of the Securities Act of 1933 and Segment 21E of the Securities Trade Act of 1934 and Private Securities Litigation Reform Act, as amended, which include those people relating to the Firm’s merchandise enhancement, medical and regulatory timelines, sector possibility, competitive placement, intellectual home rights, probable or assumed long term results of operations, business techniques, prospective growth options and other statements that are predictive in nature. These forward-hunting statements are primarily based on latest anticipations, estimates, forecasts and projections about the sector and markets in which we function and management’s present-day beliefs and assumptions.

These statements may well be recognized by the use of forward-on the lookout expressions, together with, but not restricted to, “assume,” “foresee,” “intend,” “approach,” “imagine,” “estimate,” “prospective, “predict,” “challenge,” “need to,” “would” and comparable expressions and the negatives of these conditions. These statements relate to long run situations or our economic performance and involve recognized and unidentified risks, uncertainties, and other factors which might lead to real outcomes, performance or achievements to be materially various from any potential outcomes, performance or achievements expressed or implied by the ahead-seeking statements. This kind of aspects involve these set forth in the Firm’s Once-a-year Report on Sort 10-K for the year ended December 31, 2021 as properly as other paperwork filed by the Company from time to time thereafter with the Securities and Trade Commission. Future investors are cautioned not to put undue reliance on these types of ahead-seeking statements, which speak only as of the day of this press release. The Business undertakes no obligation to publicly update any forward-on the lookout statement, no matter whether as a end result of new information and facts, upcoming situations or usually.

For far more facts, contact:

Timber Prescribed drugs, Inc. 
John Koconis 
Chairman and Main Executive Officer
[email protected]

Investor Relations:
Stephanie Prince
PCG Advisory
(646) 863-6341
[email protected]

Media Relations:
Adam Daley
Berry & Business General public Relations
(212) 253-8881
[email protected]