JAK

Aclaris Therapeutics Reports Third Quarter 2023 Financial Results and Provides a Corporate Update

Retrieved on: 
Monday, November 6, 2023

WAYNE, Pa., Nov. 06, 2023 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced its financial results for the third quarter of 2023 and provided a corporate update.

Key Points: 
  • Net loss was $29.3 million for the third quarter of 2023 compared to $20.0 million for the third quarter of 2022.
  • Total revenue was $9.3 million for the third quarter of 2023 compared to $19.0 million for the third quarter of 2022.
  • Research and development (R&D) expenses were $23.9 million for the quarter ended September 30, 2023 compared to $23.7 million for the prior year period.
  • General and administrative (G&A) expenses were $7.1 million for the quarter ended September 30, 2023 compared to $5.8 million for the corresponding prior year period.

Recludix Pharma Presents Preclinical Data Demonstrating Strong Efficacy and Favorable Safety Profile of REX-7117 Versus TYK2 and JAK Inhibitors at the Dermatology Drug Development Summit

Retrieved on: 
Tuesday, October 31, 2023

SAN DIEGO, Oct. 31, 2023 (GLOBE NEWSWIRE) -- Recludix Pharma, a leader in platform approaches to discover inhibitors of challenging targets for inflammatory disease and cancer, announced that in a presentation given today at the 7th Annual Dermatology Drug Development Summit titled “Finding the New Ground Between Safety & Efficacy in Drug Development,” Recludix’s senior vice president of biology, Paul Smith, Ph.D., reviewed the challenges associated with inhibition of the JAK/STAT pathway through TYK2 and JAK inhibitors and presented preclinical data with Recludix’s STAT3 inhibitor REX-7117, which potently and selectively targets the STAT3 Src Homology 2 (SH2) domain. The presentation is available on the company’s website under the section titled “Events.”

Key Points: 
  • “Importantly, other approaches to inhibiting the JAK/STAT pathway by targeting TYK2 or JAK have resulted in undesirable safety consequences, such as increased risk of infections or altered hematopoiesis.
  • It provides durable STAT3 inhibition and maintains in vivo selectivity against other STAT proteins, even after the administration of multi-day oral dosing in a preclinical model.
  • In a translational Th17 preclinical model of psoriasis, once daily REX-7117 (300 mg/kg) was superior to a clinically-relevant dose of deucravacitinib (1 mg/kg).
  • Moreover, twice daily REX-7117 (300 mg/kg) was comparable to deucravacitinib at a supra-clinical dose (30 mg/kg), reinforcing the rationale of STAT3 targeting as a potential disease-modifying opportunity.

LEO Pharma Announces Positive Outcome of DELTA 3 Open-Label Extension Trial of Delgocitinib Cream in the Treatment of Adults With Moderate to Severe Chronic Hand Eczema (CHE)

Retrieved on: 
Monday, October 30, 2023

LEO Pharma A/S, a global leader in medical dermatology, today announced the positive outcome of the DELTA 3 trial.

Key Points: 
  • LEO Pharma A/S, a global leader in medical dermatology, today announced the positive outcome of the DELTA 3 trial.
  • DELTA 3 is a phase 3, single-arm, open-label extension trial of delgocitinib cream, an investigational topical pan-Janus kinase (JAK)-inhibitor, for the potential treatment of adults with moderate to severe chronic hand eczema (CHE).
  • All DELTA 3 trial subjects had completed the DELTA 1 or DELTA 2 trials and were offered to immediately enroll into this extension trial.
  • Furthermore, patients who entered the DELTA 3 trial after receiving cream vehicle in the DELTA 1 and DELTA 2 trials reached similar levels of treatment success as the patients previously treated with delgocitinib cream.

Recludix Pharma Presents Preclinical Data from its STAT3 Inhibitor Program at the International Conference of the Inflammation Research Association (IRA)

Retrieved on: 
Tuesday, October 17, 2023

SAN DIEGO, Oct. 17, 2023 (GLOBE NEWSWIRE) -- Recludix Pharma, a leader in platform approaches to discover inhibitors of challenging targets for inflammatory disease and cancer, announced that in a presentation given today titled “Drugging the Undruggable,” Recludix’s senior vice president of biology, Paul Smith, Ph.D., discussed the first application of the company’s platform capabilities to target the Src Homology 2 (SH2) domain, as well as reviewed preclinical data on an early STAT3 inhibitor that was internally discovered through the platform. The presentation is available on the company’s website under the section titled “Events.”

Key Points: 
  • “In this presentation, we highlight data from one of our earlier STAT3 discovery compounds showing its highly selective STAT3 inhibition with demonstrated potency in biochemical and cellular assays.
  • We have continued to refine our lead STAT3 inhibitors and are in the final stages of confirming a STAT3 development candidate to move into clinical testing.
  • Data demonstrate that targeting STAT3 spares interferon-driven anti-viral gene transcription and avoids STAT5 signaling, which is important for hematologic homeostasis and is differentiated from JAK/TYK2 inhibition.
  • Activity for STAT3 was found to be dose-dependent in both prophylactic and therapeutic preclinical models.

LEO Pharma Presents Phase 3 Results of Delgocitinib Cream for Adults with Moderate to Severe Chronic Hand Eczema (CHE) at EADV 2023

Retrieved on: 
Friday, October 13, 2023

DELTA 2 is the second of two pivotal phase 3 clinical trials with delgocitinib cream, an investigational topical pan-Janus kinase (JAK)-inhibitor for the potential treatment of adults with moderate to severe chronic hand eczema (CHE).1,4

Key Points: 
  • DELTA 2 is the second of two pivotal phase 3 clinical trials with delgocitinib cream, an investigational topical pan-Janus kinase (JAK)-inhibitor for the potential treatment of adults with moderate to severe chronic hand eczema (CHE).1,4
    DELTA 2 was a randomized, double-blind, cream vehicle-controlled trial.
  • Adults were randomized to either twice-daily delgocitinib cream (n=314) or cream vehicle (n=159) for 16 weeks followed by a separate 36-week extension trial.
  • “Through assessment of the DELTA 1 and DELTA 2 trial results, we aim to assess the efficacy and safety of delgocitinib cream in adults living with this hard-to-treat disease."
  • “This latest collection of clinical data for delgocitinib cream supports LEO Pharma’s unwavering commitment to addressing the critical unmet need in CHE,” says Kreesten Meldgaard Madsen, Chief Development Officer, LEO Pharma.

U.S. FDA Approves Pfizer’s VELSIPITY™ for Adults with Moderately to Severely Active Ulcerative Colitis (UC)

Retrieved on: 
Friday, October 13, 2023

Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved VELSIPITY™ (etrasimod), an oral, once-daily, selective sphingosine-1-phosphate (S1P) receptor modulator for adults with moderately to severely active ulcerative colitis (UC).

Key Points: 
  • Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved VELSIPITY™ (etrasimod), an oral, once-daily, selective sphingosine-1-phosphate (S1P) receptor modulator for adults with moderately to severely active ulcerative colitis (UC).
  • Nearly two-thirds of patients in ELEVATE UC 52 and ELEVATE UC 12 were naïve to biologic or JAK inhibitor therapy, and these studies were also the only studies for advanced therapies for ulcerative colitis to include patients with isolated proctitis.
  • Both studies achieved all primary and key secondary efficacy endpoints, with a favorable safety profile consistent with previous studies of VELSIPITY.
  • “Because of the unpredictable nature of UC, people living with the disease can cycle through several different treatments over time.

New Long-Term Data from Incyte Phase 3 TRuE-V Program Demonstrates Efficacy of Continued Treatment with Opzelura® (Ruxolitinib) Cream in Nonsegmental Vitiligo Patients

Retrieved on: 
Wednesday, October 11, 2023

These long-term data highlight encouraging updates for an important sub-group of patients with nonsegmental vitiligo, those who initially showed limited or no response to treatment,” said Jim Lee, M.D., Ph.D., Group Vice President, Inflammation & AutoImmunity, Incyte.

Key Points: 
  • These long-term data highlight encouraging updates for an important sub-group of patients with nonsegmental vitiligo, those who initially showed limited or no response to treatment,” said Jim Lee, M.D., Ph.D., Group Vice President, Inflammation & AutoImmunity, Incyte.
  • Opzelura is indicated for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older.
  • The overall prevalence of the condition is estimated to be approximately 2-3 million2, with the majority of patients (approximately 85%) suffering from nonsegmental vitiligo3.
  • Vitiligo can occur at any age, although many patients with vitiligo will experience initial onset before the age of 304.

Incyte Announces Positive 52-Week Data from Phase 2b Study Evaluating Povorcitinib (INCB54707) in Patients with Extensive Nonsegmental Vitiligo

Retrieved on: 
Wednesday, October 11, 2023

Incyte (Nasdaq:INCY) today announced new 52-week data from a Phase 2b clinical trial evaluating the safety and efficacy of povorcitinib (INCB54707), an investigational oral JAK1 inhibitor, in adult patients with extensive nonsegmental vitiligo.

Key Points: 
  • Incyte (Nasdaq:INCY) today announced new 52-week data from a Phase 2b clinical trial evaluating the safety and efficacy of povorcitinib (INCB54707), an investigational oral JAK1 inhibitor, in adult patients with extensive nonsegmental vitiligo.
  • “These 52-week results further support earlier data and reinforce the efficacy profile and potential of povorcitinib as an oral treatment for patients with extensive nonsegmental vitiligo,” said Kurt Brown, M.D., Vice President and Povorcitinib Global Program Head, Incyte.
  • “At Incyte, we are deeply committed to addressing unmet needs in the vitiligo community and understanding how this disease can affect patients’ lives.
  • Vitiligo can occur at any age, although many patients with vitiligo will experience initial onset before the age of 304.

Everest Medicines' Licensing Partner Pfizer Announces U.S. FDA Approves Etrasimod for Adults with Moderately to Severely Active Ulcerative Colitis

Retrieved on: 
Monday, October 16, 2023

SHANGHAI, Oct. 15, 2023 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK) announced today that its licensing partner, Pfizer Inc. (NYSE: PFE) has received approval from the U.S. Food and Drug Administration (FDA) for VELSIPITY™ (etrasimod), an oral, once-daily, selective sphingosine-1-phosphate (S1P) receptor modulator for adults with moderately to severely active ulcerative colitis (UC).

Key Points: 
  • SHANGHAI, Oct. 15, 2023 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK) announced today that its licensing partner, Pfizer Inc. (NYSE: PFE) has received approval from the U.S. Food and Drug Administration (FDA) for VELSIPITY™ (etrasimod), an oral, once-daily, selective sphingosine-1-phosphate (S1P) receptor modulator for adults with moderately to severely active ulcerative colitis (UC).
  • Everest is conducting a multi-center Phase 3 clinical trial of etrasimod in Asia and aims to file New Drug Application as soon as possible.
  • "Etrasimod's FDA approval marks an important milestone for moderately to severely active UC patients who need new treatments for this chronic condition.
  • Everest Medicines obtained exclusive rights from Arena to develop, manufacture and commercialize etrasimod in Greater China and South Korea in 2017.

InventHelp Inventor Develops Modified Pallet Jack (NAM-348)

Retrieved on: 
Monday, October 9, 2023

My design can be adjusted to accommodate larger pallets, extra pallets, and pallets of any size."

Key Points: 
  • My design can be adjusted to accommodate larger pallets, extra pallets, and pallets of any size."
  • The invention provides a pallet jack with multi-functional mechanical capabilities for expansion and retraction.
  • In doing so, it can be used to move various warehousing load capacities and pallet sizes.
  • 21-NAM-348, InventHelp, 100 Beecham Drive, Suite 110, Pittsburgh, PA 15205-9801, or call (412) 288-1300 ext.