Ichthyosis

Azitra, Inc. Announces Q1 2024 Financial Results and Provides Business Updates

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Jeudi, mai 9, 2024
Biotechnology, Other Health, Health, Pharmaceutical, Clinical Trials, FDA, Society, Cancer, Skin, Safety, Research, Joint, Research and development, IRB, Cell, Administration, IND, LEKTI, ASCO, Ichthyosis, Patent, Patient, Gene, Bayer, Prevalence, Rash, Quarter, EGFR, G&A, Netherton syndrome, BTK, Chemotherapy, Pharmaceutical industry

Azitra, Inc. (NYSE American: AZTR), a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today reported financial results for the three months ended March 31, 2024, and provided a business update.

Key Points: 
  • Azitra, Inc. (NYSE American: AZTR), a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today reported financial results for the three months ended March 31, 2024, and provided a business update.
  • Moreover, preclinical evidence suggests that ATR-12 can markedly reduce IL-36g, a pro-inflammatory cytokine implicated in Netherton syndrome, further validating the potential of our approach.
  • Net Loss was $2.9 million for the quarter ended March 31, 2024, compared to $2.5 million for the comparable period in 2023.
  • Cash and cash equivalents: As of March 31, 2024, the Company had cash and cash equivalents of $3.0 million.

Solid Start to the Year: LEO Pharma Delivers 13% Revenue Growth Driven by Strong Performance in Dermatology

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Vendredi, mai 3, 2024
Science, Biotechnology, Research, Pharmaceutical, General Health, Health, Clinical Trials, Other Health, American Academy, Dermatitis, Phase, LEO, Risk, Delgocitinib, Annual report, Leo Pharma, Tralokinumab, Growth, DKK, Affiliation, CHE, Patient, Acquisition, Psoriasis, AAD, Skin infection, Multimedia, Marketing, Atopic dermatitis, Ichthyosis, Pharmaceutical industry

In Q1 2024, LEO Pharma delivered a revenue growth of 13% in constant exchange rates (CER).

Key Points: 
  • In Q1 2024, LEO Pharma delivered a revenue growth of 13% in constant exchange rates (CER).
  • Dermatology revenue grew 16% to DKK 2,444 million (Q1 2023: 2,150 million), driven by growth of Adtralza®/Adbry® for atopic dermatitis (AD) and solid growth in the core portfolio.
  • “First quarter marks a solid start to 2024 with a 13% revenue growth and continued progress on our strategic priorities.
  • I am pleased with the strong growth track record for our global dermatology portfolio, primarily driven by performance in North America.

Kamari Pharma Announces Abstracts Accepted for Presentation at the 81st Annual Meeting of the Society for Investigative Dermatology

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Mardi, avril 16, 2024
NESS, Society, Inflammation, Safety, Skin, Ichthyosis, Abstract, TRPV3, Keratoderma, Pharmaceutical industry

NESS ZIONA, Israel, April 16, 2024 (GLOBE NEWSWIRE) -- Kamari Pharma, a privately-held clinical stage biotechnology company developing first and best-in-class treatments for rare and severe genetic skin diseases, today announced two abstracts reporting results for its novel TRPV3 inhibitors, KM-001(topical) and KM-023 (oral), have been selected for presentation at the 81st Annual Meeting of the Society for Investigative Dermatology (SID), being held May 15-18, 2024 in Dallas, TX, USA.

Key Points: 
  • TRPV3 plays a central role in skin disease as it regulates proliferation, differentiation and barrier function of human skin.
  • KM-001 and KM-023 are specific and selective TRPV3 inhibitors that address both molecular and local damage to the skin by regulating Ca²⁺ influx into the cell, thereby reconstructing the skin barrier and reducing inflammation.
  • Kamari is currently developing KM-001 for the treatment of palmoplantar keratoderma and KM-023 for the treatment of Olmstead syndrome, severe keratoderma and Ichthyosis.
  • The details of the presentations are as follows:
    Title: Novel TRPV3 inhibitors developed for the treatment of palmoplantar keratodermas, demonstrate safety and efficacy in preclinical models

Azitra, Inc. Announces Full Year 2023 Financial Results and Provides Business Updates

Retrieved on: 
Vendredi, mars 15, 2024
Science, Biotechnology, Research, Pharmaceutical, Health, Genetics, Clinical Trials, Other Health, Prevalence, Administration, EGFR, Ichthyosis, Joint, Patient, Netherton syndrome, G&A, Cancer, IND, Rash, Bayer, Clinical trial, Research and development, Skin, BTK, Patent, FDA, Chemotherapy, Pharmaceutical industry

Azitra, Inc. (NYSE American: AZTR), a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today reported financial results for the full year ended December 31, 2023, and provided a business update.

Key Points: 
  • Azitra, Inc. (NYSE American: AZTR), a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today reported financial results for the full year ended December 31, 2023, and provided a business update.
  • Completed and filed post-IND, FDA commitments for characterization of drug substance and drug product for ATR-12.
  • Selected and hired clinical research organization for ATR-12 clinical trial and selected initial clinical sites for activation.
  • Net Loss was $11.3 million for the year ended December 31, 2023, compared to $10.7 million for the comparable period in 2022.

LEO Pharma to Maintain Leadership Role at AAD in 2024 with New Late-Breaking Data Spanning Multiple Therapeutic Areas

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Mercredi, mars 6, 2024
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, Adolescence, EVP, American Academy of Dermatology, Ichthyosis, Atopic dermatitis, Pain, Dermatology, Calendar, Annual general meeting, AAD, Safety, Pharmacokinetics, Abstract, CHE, Congress, LEO, ASCEND, Leo Pharma, American Academy, Pharmaceutical industry

LEO Pharma A/S, a global leader in medical dermatology, will present a breadth of new data on moderate-to-severe chronic hand eczema (CHE), congenital ichthyosis (CI) and atopic dermatitis (AD) at the upcoming 82nd American Academy of Dermatology (AAD) Annual Meeting.

Key Points: 
  • LEO Pharma A/S, a global leader in medical dermatology, will present a breadth of new data on moderate-to-severe chronic hand eczema (CHE), congenital ichthyosis (CI) and atopic dermatitis (AD) at the upcoming 82nd American Academy of Dermatology (AAD) Annual Meeting.
  • The event is being held from March 8th to 12th in San Diego, California.
  • “Our growing body of clinical evidence reinforces our passion and commitment to advancing the standard of care in medical dermatology,” said Kreesten Meldgaard Madsen, LEO Pharma’s Chief Development Officer.
  • I am proud that we can follow up on our 2023 AAD program with this level of critical data,” said Brian Hilberdink, EVP and President, Region North America, LEO Pharma.

Azitra, Inc. Strengthens Intellectual Property Portfolio with Newly Granted Patent in the US

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Mardi, janvier 16, 2024
Biotechnology, General Health, Health, Genetics, Pharmaceutical, Lymphocyte, Dermatology, Patient, Netherton syndrome, IP, LEKTI, Staphylococcus epidermidis, Skin, Disease, Ichthyosis, FDA, Protein, Patent, Netherton

Importantly, the indication addressed by this patent, ichthyosis vulgaris (IV), a chronic, scaly skin disease with no FDA-approved treatment option and affects approximately 1.3 million people in the United States.

Key Points: 
  • Importantly, the indication addressed by this patent, ichthyosis vulgaris (IV), a chronic, scaly skin disease with no FDA-approved treatment option and affects approximately 1.3 million people in the United States.
  • This new patent issuance reinforces the value of our platform for precision dermatology and our commitment to patient populations with no FDA-approved treatment options."
  • Azitra is developing live biotherapeutic product candidates intended to treat ichthyosis vulgaris, a disease caused by missing or abnormal filaggrin levels.
  • Azitra’s growing patent portfolio now has three granted patents in the US with numerous additional applications pending globally to further expand its IP position.

Timber Pharmaceuticals to be Acquired by LEO Pharma

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Lundi, août 21, 2023
LLP, CVR, Covington & Burling, Leo Pharma, Calendar, Securities and Exchange Commission (Nigeria), Ichthyosis, Patient, CVR Partners, LEO, Security (finance), FDA, Black–Scholes model, NYSE, Skin, Pharmaceutical industry, Lumber

As part of the transaction, LEO Pharma has agreed to provide Timber with a bridge loan of up to $3.0 million, subject to certain conditions.

Key Points: 
  • As part of the transaction, LEO Pharma has agreed to provide Timber with a bridge loan of up to $3.0 million, subject to certain conditions.
  • The payments of the CVRs are subject to certain deductions relating to the repayment of 50% of the bridge loan provided by LEO Pharma to Timber in connection with the merger.
  • LEO Pharma is a leader in global dermatology with a mission that matches our own - a relentless pursuit to help patients suffering from skin diseases.
  • Covington & Burling LLP is serving as legal counsel to LEO Pharma.

LEO Pharma Signs Agreement to Acquire Timber Pharmaceuticals

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Lundi, août 21, 2023
Health, Pharmaceutical, Skin, Leo Pharma, API, Ichthyosis, Patient, CVR, LEO, Isotretinoin, FDA, NYSE, Pharmaceutical industry

LEO Pharma today announced that it signed an agreement to acquire U.S.-listed Timber Pharmaceuticals, Inc. (NYSE American: TMBR.

Key Points: 
  • LEO Pharma today announced that it signed an agreement to acquire U.S.-listed Timber Pharmaceuticals, Inc. (NYSE American: TMBR.
  • The deal is subject to certain closing conditions including, but not limited to, Timber Pharmaceuticals’ shareholder approval.
  • Christophe Bourdon, CEO of LEO Pharma commented:
    “Signing an agreement to acquire Timber Pharmaceuticals and TMB-001, which is still subject to certain closing conditions, is an additional step in delivering on our strategy.
  • 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 to Present Interim Analyses From Phase 3 ASCEND Study of TMB-001 in Congenital Ichthyosis

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Mardi, juin 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 Announces FDA Grant of CARC Waiver for TMB-001

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Lundi, juin 5, 2023
CARC, Food, CI, Toxicity, Lamellar ichthyosis, Dermatology, Ichthyosis, ASCEND, Patient, Isotretinoin, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, NYSE, Skin, Pharmaceutical industry

WARREN, NJ, June 05, 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 U.S. Food and Drug Administration (FDA) has granted a dermal carcinogenicity (CARC) waiver for TMB-001, a topical isotretinoin formulated using the Company’s patented IPEG™ delivery system. The positive opinion is based on results of a 39-week repeat dose dermal toxicity study that demonstrated no evidence of skin or organ carcinogenicity from chronic applications of TMB-001 in rodents and allows the Company to forgo a 2-year dermal rodent carcinogenicity study.

Key Points: 
  • “We are committed to delivering a new topical treatment option for people living with moderate to severe congenital ichthyosis (CI).
  • The CARC waiver is important because we can avoid a costly and lengthy non-clinical study, which we believe will allow us to push ahead with our TMB-001 program as quickly and efficiently as possible.
  • In 2018, the FDA awarded an Orphan Products Grant to support clinical trials evaluating TMB-001, including the Phase 3 ASCEND study.
  • Timber has also received both Breakthrough Therapy Designation and Fast Track Status from the FDA for TMB-001.