Clinical Trials

LEO Pharma Unveils Late-Breaking Data for Landmark DELTA 3 Open-Label Extension Trial at the 2024 AAD Annual Meeting

Retrieved on: 
Saturday, March 9, 2024

For DELTA 3, subjects who completed the 16-week treatment period in one of the parent trials DELTA 1 and DELTA 2 were treated with twice daily delgocitinib cream as needed to control their chronic hand eczema for 36 weeks.

Key Points: 
  • For DELTA 3, subjects who completed the 16-week treatment period in one of the parent trials DELTA 1 and DELTA 2 were treated with twice daily delgocitinib cream as needed to control their chronic hand eczema for 36 weeks.
  • “Having the opportunity to present the DELTA 3 findings for the first time at AAD is a chance to prove our complete dedication to addressing the immense burden of this disease.
  • By continuing to share our key data at major dermatology congresses, we hope to drive forward the clinical development of delgocitinib cream as a potential new treatment option.”
    Key secondary endpoints demonstrated an efficacy profile consistent with DELTA 1 and 2 parent trials.
  • Alongside the presentation, new data sets at AAD were shared as e-posters from the preceding DELTA 1 and 2 trials regarding safety, efficacy and systemic exposure.2,3,4

RenovoRx Highlights Key Leadership Promotions

Retrieved on: 
Friday, March 8, 2024

(“RenovoRx” or the “Company”) (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing novel precision oncology therapies based on a local drug-delivery platform, today highlighted the recent key leadership promotions of Leesa Gentry to Chief Clinical Officer and Ronald B. Kocak, CPA to Principal Accounting Officer.

Key Points: 
  • (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing novel precision oncology therapies based on a local drug-delivery platform, today highlighted the recent key leadership promotions of Leesa Gentry to Chief Clinical Officer and Ronald B. Kocak, CPA to Principal Accounting Officer.
  • Since joining RenovoRx, Ms. Gentry has demonstrated exemplary leadership and commitment to advancing the Company’s clinical pipeline.
  • Mr. Kocak has been promoted to the position of Principal Accounting Officer and will retain his roles as Vice President and Controller of RenovoRx.
  • In this new leadership role, Mr. Kocak will oversee all financial management, reporting and strategic planning initiatives crucial to furthering the Company’s research and development efforts.

LEO Pharma Presents New Long-Term Adbry® (tralokinumab-ldrm) Data in Adults with Moderate-to-Severe Atopic Dermatitis at the 2024 AAD Annual Meeting

Retrieved on: 
Friday, March 8, 2024

LEO Pharma A/S, a global leader in medical dermatology, today unveiled new data analyzing the long-term therapeutic response of treatment with Adbry® (tralokinumab-ldrm) in adults (18 years and above) with moderate-to-severe atopic dermatitis (AD).

Key Points: 
  • LEO Pharma A/S, a global leader in medical dermatology, today unveiled new data analyzing the long-term therapeutic response of treatment with Adbry® (tralokinumab-ldrm) in adults (18 years and above) with moderate-to-severe atopic dermatitis (AD).
  • The findings are being shared via an e-poster at the 82nd American Academy of Dermatology (AAD) Congress in San Diego, California.1
    The results are part of a wide-ranging data program from LEO Pharma at AAD, with eight abstracts accepted in total for the meeting, showcasing an ongoing commitment to advancing the standard of research in medical dermatology.
  • “The data presented for Adbry at AAD further builds upon an established, wide-ranging collection of clinical evidence that aims to improve the support for those living with moderate-to-severe AD,” said Brian Hilberdink, EVP and President, Region North America, LEO Pharma.
  • “This new analysis demonstrates the benefits of the long-term use of Adbry for adults who live with this chronic condition.”

Graphite Bio Declares Special Dividend In Connection with Proposed Merger with Lenz Therapeutics

Retrieved on: 
Friday, March 8, 2024

Graphite Bio, Inc. (Nasdaq: GRPH) (“Graphite” or the “Company”) today announced that its Board of Directors has declared a special dividend in connection with the previously announced merger (the “Merger”) with Lenz Therapeutics, Inc. (“LENZ”) pursuant to the Agreement and Plan of Merger, dated November 14, 2023 (the “Merger Agreement”).

Key Points: 
  • Graphite Bio, Inc. (Nasdaq: GRPH) (“Graphite” or the “Company”) today announced that its Board of Directors has declared a special dividend in connection with the previously announced merger (the “Merger”) with Lenz Therapeutics, Inc. (“LENZ”) pursuant to the Agreement and Plan of Merger, dated November 14, 2023 (the “Merger Agreement”).
  • The special dividend, which the Company estimates will be $1.03 per share of Graphite’s common stock, will be payable in cash to the stockholders of record as of March 18, 2024.
  • The exact amount of the special dividend will be calculated after deducting certain cash amounts as set forth in the Merger Agreement.
  • The special dividend will not exceed an amount equal to $60 million, subject to the adjustments set forth in the Merger Agreement.

Castle Biosciences to Present New Data Highlighting the Clinical Value of its Dermatologic Tests for Patients with Skin Cancer at the 2024 American Academy of Dermatology (AAD) Annual Meeting

Retrieved on: 
Friday, March 8, 2024

In the study, use of the DecisionDx-Melanoma test was associated with improved melanoma-specific survival relative to untested patients.

Key Points: 
  • In the study, use of the DecisionDx-Melanoma test was associated with improved melanoma-specific survival relative to untested patients.
  • The study data demonstrate that clinicians are utilizing the DecisionDx-SCC test appropriately for patients with high-risk cutaneous squamous cell carcinoma (SCC).
  • These data support incorporating the test’s results into clinical practice to improve the accuracy of risk predictions to guide more personalized treatment plans for patients.
  • Approximately 80% of clinically tested lesions with a malignant MyPath result have sufficient biopsy tumor content for DecisionDx-Melanoma testing.

Seismic Therapeutic to Present Preclinical Data for Novel Immunoglobulin Sculpting Enzyme at AAN Annual Meeting

Retrieved on: 
Friday, March 8, 2024

Seismic Therapeutic, Inc ., the machine learning immunology company, today announced that the company will present preclinical data for its pan-immunoglobulin G (IgG) sculpting enzyme candidate, S-1117, at the American Academy of Neurology (AAN) annual meeting taking place on April 13-18 in Denver.

Key Points: 
  • Seismic Therapeutic, Inc ., the machine learning immunology company, today announced that the company will present preclinical data for its pan-immunoglobulin G (IgG) sculpting enzyme candidate, S-1117, at the American Academy of Neurology (AAN) annual meeting taking place on April 13-18 in Denver.
  • S-1117 is a novel engineered pan-IgG protease for the potential treatment of a range of chronic and acute autoantibody mediated diseases, including the chronic neuromuscular autoimmune disorder, myasthenia gravis.
  • The presentation at the AAN annual meeting will outline key preclinical in vitro and in vivo results supporting the differentiated profile of S-1117 compared to therapeutic benchmarks in chronic autoantibody mediated diseases.
  • Title: Preclinical Pharmacology of S-1117, a Novel Engineered Fc-fused IgG Cleaving Enzyme, for Chronic Treatment of Autoantibody-mediated Diseases

Janux Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Business Highlights

Retrieved on: 
Friday, March 8, 2024

“2023 was a critical year for Janux as we tested the potential power of our TRACTr platform in the clinic.

Key Points: 
  • “2023 was a critical year for Janux as we tested the potential power of our TRACTr platform in the clinic.
  • RECENT BUSINESS HIGHLIGHTS AND FUTURE MILESTONES:
    Presented positive updated interim Phase 1 clinical trial data for PSMA-TRACTr JANX007 in prostate cancer in February 2024.
  • Janux plans to deploy these funds to expand development of clinical programs, advance additional preclinical programs and extend corporate runway.
  • FOURTH QUARTER AND FULL YEAR 2023 FINANCIAL RESULTS:
    Cash and cash equivalents and short-term investments: As of December 31, 2023, Janux reported cash and cash equivalents and short-term investments of $344.0 million compared to $327.0 million at December 31, 2022.

Amylyx Pharmaceuticals Announces Topline Results From Global Phase 3 PHOENIX Trial of AMX0035 in ALS

Retrieved on: 
Friday, March 8, 2024

Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced topline results from PHOENIX, a global, 48-week, randomized, placebo-controlled Phase 3 clinical trial of AMX0035 (sodium phenylbutyrate and taurursodiol [also known as ursodoxicoltaurine]; RELYVRIO® in the U.S., ALBRIOZA™ in Canada) in people living with amyotrophic lateral sclerosis (ALS).

Key Points: 
  • Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced topline results from PHOENIX, a global, 48-week, randomized, placebo-controlled Phase 3 clinical trial of AMX0035 (sodium phenylbutyrate and taurursodiol [also known as ursodoxicoltaurine]; RELYVRIO® in the U.S., ALBRIOZA™ in Canada) in people living with amyotrophic lateral sclerosis (ALS).
  • Amylyx intends to share plans for RELYVRIO/ALBRIOZA in ALS, which may include voluntarily withdrawing RELYVRIO/ALBRIOZA from the market.
  • “We are surprised and deeply disappointed by the PHOENIX results following the positive data from the CENTAUR trial.
  • Update on Ongoing AMX0035 Studies:
    The global, randomized, double-blind, placebo-controlled Phase 3 ORION clinical study of AMX0035 in PSP remains ongoing.

Thermo Fisher Scientific Launches CorEvitas Clinical Registry in Generalized Pustular Psoriasis

Retrieved on: 
Friday, March 8, 2024

Thermo Fisher Scientific Inc., the world leader in serving science, today announced the launch of a new CorEvitas syndicated clinical registry in generalized pustular psoriasis (GPP).

Key Points: 
  • Thermo Fisher Scientific Inc., the world leader in serving science, today announced the launch of a new CorEvitas syndicated clinical registry in generalized pustular psoriasis (GPP).
  • This registry, which is open to enrollment, is CorEvitas’ 10th syndicated disease registry and addresses an unmet need for real-world evidence (RWE) related to the clinical and patient-reported outcomes of patients with GPP.
  • Thermo Fisher acquired CorEvitas, a leading provider of gold-standard real-world evidence solutions, in August 2023.
  • The registry was launched with clinical guidance from two leading GPP clinical experts who serve as scientific advisors: Dr. Mark Lebwohl, dean for clinical therapeutics, Icahn School of Medicine at Mount Sinai; and Dr. Bruce Strober, clinical professor, Department of Dermatology at Yale University.

Arrowhead Pharmaceuticals Initiates Phase 1/2a Study of ARO-DM1 for Treatment of Type 1 Myotonic Dystrophy

Retrieved on: 
Friday, March 8, 2024

Patients with DM1 have muscle weakness and wasting, myotonia, cataracts, and often develop cardiac conduction abnormalities.

Key Points: 
  • Patients with DM1 have muscle weakness and wasting, myotonia, cataracts, and often develop cardiac conduction abnormalities.
  • Pathogenesis of DM1 is driven by an expanded CUG trinucleotide repeat in the 3’-untranslated region of DMPK transcripts.
  • These abnormal transcripts cause mis-regulated splicing, known as spliceopathy, for certain messenger RNAs which are directly linked to the clinical manifestations of DM1.
  • Presentation materials may be accessed on the Events and Presentations page under the Investors section of the Arrowhead website.