ARCI

Timber Pharmaceuticals to Present Interim Analyses From Phase 3 ASCEND Study of TMB-001 in Congenital Ichthyosis

Retrieved on: 
Tuesday, June 20, 2023
Tretinoin, PK, Society, Dermis, Stanford University, Must, Food, CI, XLRI, Epidermis, Pediatric Dermatology, Dermatology, Toxicity, Absorption, Plasma, Ichthyosis, IGA, Professor, ASCEND, Patient, Collection, Lumber, Isotretinoin, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, NYSE, Skin, Safety, ARCI, Body surface area, Pharmaceutical industry

WARREN, NJ, June 20, 2023 (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 interim pharmacokinetic (PK) analyses from the Phase 3 ASCEND study indicate minimal systemic absorption of isotretinoin or its major metabolites in patients with moderate to severe forms of congenital ichthyosis (CI) who were treated with TMB-001 0.05% ointment. Full PK results will be presented during the Society for Pediatric Dermatology’s Annual Meeting to be held July 13-16, 2023, in Asheville, North Carolina.

Key Points: 
  • Full PK results will be presented during the Society for Pediatric Dermatology’s Annual Meeting to be held July 13-16, 2023, in Asheville, North Carolina.
  • The primary endpoint is the difference in proportions of treated patients with 2-point Investigator's Global Assessment (IGA) scaling/fissuring score improvement from baseline at 12 weeks.
  • The interim PK analyses include the first nine patients who completed 15 days of the MuST study.
  • The results indicate minimal absorption of isotretinoin when TMB-001 0.05% is applied to 75-90% of the body surface area.

Timber Pharmaceuticals Provides Business Update and Announces First Quarter 2023 Financial Results

Retrieved on: 
Monday, May 15, 2023
Maintenance, Clinical and Experimental Dermatology, Civil service commission, Bank statement, CI, Clinical trial, XLRI, Dermatology, Fast Track, Breakthrough therapy, Ichthyosis, Publication, CONTROL, ASCEND, Patient, X-linked ichthyosis, Security (finance), Isotretinoin, FDA, EC, NYSE, Skin, European Commission, ARCI, Pharmaceutical industry, Lumber

WARREN, NJ, May 15, 2023 (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 provided a business update and announced financial results for the first quarter ended March 31, 2023.

Key Points: 
  • WARREN, NJ, May 15, 2023 (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 provided a business update and announced financial results for the first quarter ended March 31, 2023.
  • John Koconis, Chairman and Chief Executive Officer of Timber, commented, “The development of our lead asset, TMB-001, continued to progress on several fronts during the first quarter of 2023.
  • For the first quarter ended March 31, 2023, Timber recorded no revenue compared to revenue of $83,177 in the first quarter of 2022.
  • For Timber’s complete financial results for the first quarter ended March 31, 2023, see the Company’s Quarterly Form 10-Q filed with the Securities and Exchange Commission on May 15, 2023.

Timber Pharmaceuticals Provides Business Update and Announces Fourth Quarter and Year End 2022 Financial Results

Retrieved on: 
Friday, March 31, 2023
Clinical and Experimental Dermatology, Civil service commission, Intellectual property, Commission, CI, Clinical trial, XLRI, Skin, American Academy, Fast Track, Sale, Breakthrough therapy, Journal of the American Academy of Dermatology, Ichthyosis, ASCEND, CONTROL, Patient, X-linked ichthyosis, Security (finance), Isotretinoin, FDA, EC, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, NYSE, Food, European Commission, ARCI, Pharmaceutical industry, Cryptocurrency, Dermatology, Lumber

WARREN, NJ, March 31, 2023 (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 provided a business update and announced financial results for the fourth quarter and year ended December 31, 2022.

Key Points: 
  • John Koconis, Chairman and Chief Executive Officer of Timber, commented, “Timber had an exciting year in 2022 and achieved several significant milestones.
  • These designations, combined with the positive Phase 2b results, are assisting in our Phase 3 ASCEND clinical trial recruitment, which has now reached 50%.
  • In Spring 2022, Timber received Breakthrough Therapy designation and Fast Track designation from the FDA for TMB-001.
  • For Timber’s complete financial results for the fourth quarter and year ended December 31, 2022, see the Company’s Annual Form 10-K filed with the Securities and Exchange Commission on March 31, 2023.

U.S. Thoroughbred Racing Enters New Era as Uniform Anti-Doping Program Takes Effect

Retrieved on: 
Monday, March 27, 2023
Lazarus, HISA, Safety, ARCI, Federal Trade Commission, Horse, Science, Organization, Congress, ADMC, WADA, Association of Film Commissioners International, Laboratory, FTC, World Anti-Doping Agency, FEI, Chair

"Having a uniform anti-doping program in place for the first time ever will be a game changer for American horse racing," said HISA CEO Lisa Lazarus.

Key Points: 
  • "Having a uniform anti-doping program in place for the first time ever will be a game changer for American horse racing," said HISA CEO Lisa Lazarus.
  • Among other members of HIWU's leadership team are experts with decades of experience working in anti-doping, including in Thoroughbred racing, as well as in federal law enforcement.
  • The ADMC Program incorporates internationally recognized standards set by organizations including the Association of Racing Commissioners International (ARCI), World Anti-Doping Agency (WADA) and Fédération Equestre Internationale (FEI).
  • HISA's Racetrack Safety Program, which established uniform operational safety rules and racetrack accreditation standards, took effect upon receiving approval from the FTC on July 1, 2022.

Timber Pharmaceuticals Announces Publication of Sub-Analysis of Phase 2b CONTROL study in Clinical and Experimental Dermatology

Retrieved on: 
Monday, March 20, 2023
Clinical and Experimental Dermatology, Civil service commission, Ichthyosis, CI, Aes, XLRI, Quality of life, Associate, British Association of Dermatologists, Yale School of Medicine, IGA, CONTROL, Patient, CED, PP, X-linked ichthyosis, Isotretinoin, ITT, NYSE, European Commission, Safety, ARCI, Disease, Pharmaceutical industry, Dermatology

BASKING RIDGE, NJ, March 20, 2023 (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 the online publication of a sub-analysis of the Phase 2b CONTROL study in Clinical and Experimental Dermatology (CED), the educational journal of the British Association of Dermatologists. The CONTROL study evaluated TMB-001, a topical isotretinoin formulated using the Company’s patented IPEG™ delivery system, in subjects nine years of age and older with moderate to severe congenital ichthyosis (CI).

Key Points: 
  • The CONTROL study evaluated TMB-001, a topical isotretinoin formulated using the Company’s patented IPEG™ delivery system, in subjects nine years of age and older with moderate to severe congenital ichthyosis (CI).
  • CI is a group of rare genetic keratinization disorders that lead to dry, thickened, and scaling skin.
  • “In this sub-analysis, participants in the CONTROL study with ARCI and XLRI mostly showed comparable percentage differences in responses to treatment with a novel topical isotretinoin formulation versus vehicle.
  • The intent-to-treat (ITT) population consisted of all randomized participants who received one or more doses of the study medication.

Timber Pharmaceuticals Receives European Orphan Drug Designation for TMB-001 in X-Linked Recessive Ichthyosis

Retrieved on: 
Friday, February 24, 2023
Epidermis, Clinical trial, Marketing, Safety, Hearing, CI, Civil service commission, Quality of life, Perspiration, EC, European, Rare, ASCEND, NYSE, Disease, Ichthyosis, Pharmacokinetics, Patient, X-linked ichthyosis, XLRI, Isotretinoin, Pivotal, Lumber, European Commission, Motion, Dermis, ARCI, Pharmaceutical industry, EU

BASKING RIDGE, NJ, Feb. 24, 2023 (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 the European Commission (EC) granted orphan drug designation for TMB-001 for the treatment of X-linked recessive ichthyosis (XLRI) on February 15, 2023. The EC previously granted orphan drug designation for TMB-001 for the treatment of autosomal recessive congenital ichthyosis (ARCI).

Key Points: 
  • The EC previously granted orphan drug designation for TMB-001 for the treatment of autosomal recessive congenital ichthyosis (ARCI).
  • “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.
  • Orphan drug designation is available for treatments for rare diseases that are life-threatening or chronically debilitating that affect fewer than five in 10,000 people across the European Union (EU).

Timber Pharmaceuticals to Host Investor Business Briefing: Milestone Achievements and Forward Outlook

Retrieved on: 
Wednesday, December 14, 2022
European Commission, CMC, Intellectual property, Clinical trial, Annual report, NYSE, Webcast, Nature, Chemistry, Security (finance), ET, Learning, Ichthyosis, Skin, ASCEND, ARCI, Genta (company), Union, Royal commission, Birth defect, Fast track (FDA), Q&A, Pharmaceutical industry, MD

BASKING RIDGE, NJ, Dec. 14, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire – 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 it will host a virtual investor Business Briefing with Q&A on December 20, 2022, at 10:30 am ET.

Key Points: 
  • John Koconis, Chairman and Chief Executive Officer of Timber, will discuss the Company’s milestone achievements in 2022, as well as what investors can expect to see in 2023 and beyond.
  • TMB-001 (IPEG™ topical isotretinoin) is our lead product and is being developed for the treatment of moderate to severe subtypes of congenital ichthyosis.
  • Congenital ichthyosis (CI) is a rare and serious inherited skin disorder characterized by dry, scaling skin that often is abnormally thick.
  • Timber Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of treatments for rare and orphan dermatologic diseases.

Timber Pharmaceuticals Receives European Orphan Designation for Autosomal Recessive Congenital Ichthyosis & Positive Comments on Pediatric Investigation Plan for TMB-001 in Autosomal Recessive CI & X-Linked Recessive Ichthyosis

Retrieved on: 
Tuesday, October 25, 2022
European Medicines Agency, U.S. Securities and Exchange Commission, EC, Union, PIP, Pharmacokinetics, Securities Act of 1933, Lumber, NYSE, GLOBE, Birth defect, Skin, European Commission, Nature, Marketing, ARCI, Annual report, Private Securities Litigation Reform Act, Isotretinoin, Industry, XLRI, X-linked ichthyosis, Clinical trial, Chemistry, ASCEND, Patient, Securities Exchange Act of 1934, MAA, Company, Genta (company), Ichthyosis, EMA, Program, CMC, Royal commission, Intellectual property, Security (finance), Degenerative disease, Safety, Pharmaceutical industry, EU

BASKING RIDGE, NJ, Oct. 25, 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 the European Commission (EC) has granted orphan designation for TMB-001 for the treatment of autosomal recessive congenital ichthyosis (ARCI). The European Medicines Agency (EMA) Pediatric Committee (PDCO) also provided positive comments on the Pediatric Investigation Plan (PIP) for the treatment of ARCI and X-linked recessive ichthyosis (XLRI), setting the basis for a final discussion in mid-November, which is a prerequisite for filing a Marketing Authorization Application (MAA) with the EMA.

Key Points: 
  • We are executing on a well-defined plan to address these unmet needs, not just in the U.S., but around the world, including Europe and other regions.
  • Congenital ichthyosis is a group of rare genetic keratinization disorders that lead to dry, thickened, and scaling skin.
  • 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 is initially focused on developing non-systemic treatments for rare dermatologic diseases including congenital ichthyosis (CI) and sclerotic skin diseases.

Timber Pharmaceuticals Receives Positive Opinion on Orphan Designation from European Medicines Agency for TMB-001 for Treatment of Autosomal Recessive Congenital Ichthyosis

Retrieved on: 
Wednesday, September 14, 2022
Securities Exchange Act of 1934, CMC, Safety, NYSE, FDA, COMP, CI, Food, Drug Quality and Security Act, European Medicines Agency, Lumber, Isotretinoin, Nature, Company, European Commission, Genta (company), Sex linkage, Intellectual property, Degenerative disease, Securities Act of 1933, Industry, U.S. Securities and Exchange Commission, Patient, Clinical trial, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, ASCEND, X-linked ichthyosis, Annual report, Private Securities Litigation Reform Act, XLRI, Committee, Pharmacokinetics, Ichthyosis, GLOBE, Royal commission, Union, Marketing, Security (finance), EMA, Chemistry, Pharmaceutical industry, EU, ARCI

BASKING RIDGE, NJ, Sept. 14, 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 the Committee for Orphan Medicinal Products (COMP) at the European Medicines Agency (EMA) issued a positive opinion on the Company’s application for orphan designation for TMB-001 for the treatment of autosomal recessive congenital ichthyosis (ARCI). Based on the COMP’s opinion, the European Commission is expected to issue its decision on the orphan designation in approximately 30 days.

Key Points: 
  • Based on the COMPs opinion, the European Commission is expected to issue its decision on the orphan designation in approximately 30 days.
  • I want to thank our team at Timber and all trial investigators and patients who have helped us reach this stage in development.
  • As we wait for the European Commission to issue its decision to hopefully grant orphan designation for TMB-001 in ARCI, Timber now plans to also submit an application for EMA orphan designation for TMB-001 for the treatment of X-linked ichthyosis.
  • Timber Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of treatments for rare and orphan dermatologic diseases.

Timber Pharmaceuticals Announces First Patients Enrolled in Phase 3 ASCEND Clinical Trial Evaluating TMB-001 in Congenital Ichthyosis

Retrieved on: 
Thursday, June 23, 2022
Intellectual property, Industry, Security (finance), FDA, Securities Exchange Act of 1934, Safety, Annual report, ARCI, Genta (company), Chemistry, Company, U.S. Securities and Exchange Commission, Pharmacokinetics, TSC, Private Securities Litigation Reform Act, Securities Act of 1933, GLOBE, Drug Quality and Security Act, Dermatology, Nature, CI, ASCEND, Lumber, Fas, Patient, Breakthrough therapy, CMC, Genetic testing, Toxicity, NYSE, Isotretinoin, Ichthyosis, Moderate, Pharmaceutical industry

BASKING RIDGE, NJ, June 23, 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 the first four patients have been enrolled in the pivotal Phase 3 ASCEND clinical trial.  ASCEND will evaluate the efficacy, pharmacokinetics and safety of TMB-001 0.05%, a topical isotretinoin formulated using the Company’s patented IPEG™ delivery system, for the treatment of moderate to severe forms of congenital ichthyosis (CI).

Key Points: 
  • The U.S. Food & Drug Administration (FDA) awarded a $1.5 million grant through its Orphan Products Clinical Trials Grant program to support completed Phase 2a and Phase 2b clinical trials that evaluated TMB-001.
  • Leading research centers in the U.S., Canada, Italy, France, and Germany are participating in the ASCEND study.
  • The first patients were enrolled by Kenneth Dawes, M.D., and his research team at the Dawes Fretzin Dermatology Group in Indianapolis, Indiana.
  • Timber is providing genetic testing as part of the study for patients whose subtype of CI is not already genetically confirmed.