JAK

BMS Attributes Sotyktu Falling Short of Growth Expectations to Access, but Recent Spherix Global Insights’ Data Suggest Safety Concerns Are More of a Barrier to Increased Uptake

Retrieved on: 
Thursday, December 7, 2023
Family, Risk, Johnson & Johnson, Aes, Infection, Q4, Physician, HCP, FDA, Thrombosis, RealTime, Venereology, JAK, BMS, Launch, Benchmarking, Patient, Safety, Psoriasis, TYK2, Malignancy, LTE, TYK, Pharmaceutical industry

There's apprehension surrounding potential side effects and adverse events, notably cardiac incidents, malignancy, thrombosis, and the risk of infection.

Key Points: 
  • There's apprehension surrounding potential side effects and adverse events, notably cardiac incidents, malignancy, thrombosis, and the risk of infection.
  • One participating dermatologist highlights, “even though it's not a direct JAK inhibitor, it still is in that same family.
  • Contact rates between BMS sales representatives and healthcare professionals have consistently increased, with the majority now reporting interactions with a Sotyktu representative since launch.
  • An influential factor in reshaping safety perceptions regarding the oral psoriasis treatment involves BMS’ ongoing long-term-extension (LTE) trial, known as POETYK.

When it Comes to Treating Ulcerative Colitis, US Gastroenterologists May be Betting it All on JAK…

Retrieved on: 
Thursday, November 30, 2023
Marketing, IBD, Failure, Adalimumab, Risankizumab, MOA, Gastroenterology, Physician, Ustekinumab, HCP, Ulcerative colitis, Injection, UC, RealTime, JAK, Patient, Celltrion, Upadacitinib, Pharmaceutical industry

Over the past two months, the landscape of UC treatment has undergone a significant expansion, introducing four new options.

Key Points: 
  • Over the past two months, the landscape of UC treatment has undergone a significant expansion, introducing four new options.
  • The first line of UC treatment remains overwhelmingly dominated by the firmly established anti-TNF therapies (such as Humira and Remicade) alongside Entyvio.
  • Furthermore, the favored choice among physicians in Crohn’s disease (CD), Stelara, has continued to enjoy a position in later-line UC treatment.
  • Patient Chart Dynamix™ is an independent, data-driven service unveiling real patient management patterns through rigorous analysis of large-scale patient chart audits.

Equillium Announces Update on Multi-Cytokine Inhibitors EQ101 & EQ102 in Development for Alopecia Areata and Celiac Disease

Retrieved on: 
Thursday, December 21, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Cytokine, Minoxidil, Alopecia areata, Male, Steroid, JAK, Skin, Patient, Therapy, Female, History, Methotrexate, Pharmaceutical industry

“We are pleased to have completed enrollment of the EQ101 Phase 2 study in alopecia areata,” said Bruce Steel, chief executive officer at Equillium.

Key Points: 
  • “We are pleased to have completed enrollment of the EQ101 Phase 2 study in alopecia areata,” said Bruce Steel, chief executive officer at Equillium.
  • “We have enrolled a total of 36 patients in the study, of which 13, or 36 percent, had very severe alopecia areata.
  • These patients are in need of new treatments that may have an improved safety profile compared to recently approved JAK inhibitors.
  • This development also illustrates the utility and modularity of our multi-cytokine platform in generating novel, first-in-class therapeutic candidates.”

New Insights Revealed On Tissue-Dependent Roles of JAK Signaling in Inflammation

Retrieved on: 
Thursday, December 21, 2023
Biology, MTR, Dermatitis, DOI, Hospital, Atopic dermatitis, Protein, FAAD, Family, Immune system, Division, Neuron, Sensation, Allergy, British Columbia Children's Hospital, Research, Cell, DRS, University of British Columbia, Sol, Disease, Tissue, Mouse, Rheumatoid arthritis, Cancer, Inflammation, Asthma, FRCPC, University, JAK, Mutation, Faculty, Hypereosinophilic syndrome, Nervous system, Gene, Lung, MBBS, Neuroinflammation, Patient, JAK1, Medical school, Diagnosis, Canada Research Chair, STAT6, Signal, Pharmaceutical industry

NEW YORK, Dec. 21, 2023 /PRNewswire-PRWeb/ -- Researchers at the Icahn School of Medicine at Mount Sinai have gained a deeper understanding of the nuanced roles of JAK inhibitors, or modulators, in inflammation across various cell types and tissues. Their findings suggest a more precise approach is required to potentially expand JAK inhibitor use to a wider range of allergy and inflammatory disorders. Details on the findings were published in the December 21, 2023, issue of the journal Cell (DOI: 10.1016/j.cell.2023.11.027).

Key Points: 
  • Their findings suggest a more precise approach is required to potentially expand JAK inhibitor use to a wider range of allergy and inflammatory disorders.
  • Current JAK inhibitors work well against inflammation in diseases like eczema, but the study suggests a need for a nuanced approach in modulating JAK activity for conditions like asthma.
  • The study showed that activated JAK1 signaling has tissue-specific effects, including an unexpected immunoregulatory role in lung sensory neurons, where it suppresses lung inflammation.
  • In the lung neurons of the mice, the JAK1 mutant protein reduced inflammation caused by exposure to mold by producing substances that suppress inflammation.

Eli Lilly's Olumiant and Pfizer's Litfulo Strengthen Alopecia Areata Arsenal, Yet Resounding Opportunity for JAK Expansion and New Assets in Development Remain

Retrieved on: 
Wednesday, November 15, 2023
SUN, Feedback, Safety, Deucravacitinib, JAK, HUB, Patient satisfaction, Dermatology, AA, Baricitinib, Patient, Alopecia areata, Element, FDA, Benchmarking, Lilly, Hair loss, Launch, Upadacitinib, Communication, Physician, Horizon, Education, Pharmaceutical industry, Marketing, Pfizer

Despite this, Olumiant is anticipated to maintain a substantial lead over Litfulo in the market.

Key Points: 
  • Despite this, Olumiant is anticipated to maintain a substantial lead over Litfulo in the market.
  • Prescribers of both brands express high and comparable satisfaction levels, far surpassing the satisfaction rates associated with non-advanced systemic treatment options.
  • Recent data from Spherix's published studies highlight minimal differentiation among prescribers regarding the two JAK inhibitors.
  • Furthermore, barriers preventing increased use of either JAK inhibitor remain closely contested, with safety concerns topping the list for each asset.

Biora Therapeutics Provides Corporate Update and Reports Third Quarter 2023 Financial Results

Retrieved on: 
Monday, November 13, 2023
EASD, Negotiation, SAN, Capital structure, Extrapyramidal system, IND$FILE, Therapy, Toxicity, JAK, IND, File, Liver, Comparison, RSU, Patient, Data analysis, FDA, Animal, Ulcerative colitis, GI, Aviation, Patent, Pharmaceutical industry, Clothing, Cryptocurrency, Diabetes

SAN DIEGO, Nov. 13, 2023 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that is reimagining therapeutic delivery, today provided a corporate update and reported financial results for the third quarter ended September 30, 2023.

Key Points: 
  • Pharma collaborations accelerate for the BioJet™ Systemic Oral Delivery platform, which shows potential for liver-targeted delivery of large molecules
    SAN DIEGO, Nov. 13, 2023 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that is reimagining therapeutic delivery, today provided a corporate update and reported financial results for the third quarter ended September 30, 2023.
  • “The third quarter was also marked by accelerating development of our BioJet™ platform.
  • We progressed our three existing pharma collaborations during the quarter and are actively negotiating with a potential fourth pharma collaborator.
  • Biora filed an IND application with the FDA for BT-600 in September 2023.

US Gastroenterologist Projections Suggest Significant Shift in Ulcerative Colitis Landscape Afoot, with Launches of Eli Lilly's Omvoh, Pfizer's Velsipity, Takeda's Subcutaneous Entyvio, and Celltrion's Zymfentra

Retrieved on: 
Monday, November 13, 2023
HCP, Ustekinumab, Pfizer, Q3, JAK, Takeda, Patient, MOA, AbbVie, Colitis, Ulcerative colitis, Benchmarking, IBD, Launch, Upadacitinib, BMS, S1P, Infliximab, Adalimumab, Gastroenterology, Celltrion, UC, RealTime, Pharmaceutical industry, Tofacitinib, Vedolizumab, Lilly

These additions come amidst an already bustling market, teeming with both branded and increasingly competitive biosimilar alternatives.

Key Points: 
  • These additions come amidst an already bustling market, teeming with both branded and increasingly competitive biosimilar alternatives.
  • However, the influx of innovative agents suggests that upcoming changes are poised to be more substantial and transformative.
  • This extension enjoys the highest pre-launch familiarity and generates significantly higher interest in gaining approval.
  • Although prescribers display significant enthusiasm for Entyvio SC, its anticipated impact on the broader market is projected to be modest.

MorphoSys’ Pelabresib Improves All Four Hallmarks of Myelofibrosis in Phase 3 MANIFEST-2 Study

Retrieved on: 
Monday, December 11, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Cough, FACP, Spleen, PST, Food, European Medicines Agency, JAK, GMT, ASH, Headache, Plasma, Disease, Constipation, IL-6, Fatigue, MorphoSys, Patient, Thrombocytopenia, CET, Periodic breathing, Weakness, COVID-19, Prognosis, Diarrhea, Nausea, Survival, EST, Dysgeusia, TNF, Anemia, Fibrosis, Ruxolitinib, BET, Bone marrow, Dizziness, Vaccine, Dietary supplement, Medical imaging

Average hemoglobin levels were greater in patients receiving pelabresib and ruxolitinib than in those receiving placebo plus ruxolitinib, starting at week 9 and continuing to week 24.

Key Points: 
  • Average hemoglobin levels were greater in patients receiving pelabresib and ruxolitinib than in those receiving placebo plus ruxolitinib, starting at week 9 and continuing to week 24.
  • Increased cytokine levels are associated with all four disease hallmarks; increased IL-8 levels are also associated with worse survival outcomes.
  • Discontinuation rates due to adverse events were 10.7% with pelabresib and ruxolitinib and 6.5% with placebo plus ruxolitinib.
  • “The four hallmarks of myelofibrosis – enlarged spleen, anemia, bone marrow fibrosis and disease-associated symptoms – have a strong impact on a patient’s life.

Geron Announces Fifty Percent Enrollment in the Phase 3 IMpactMF Clinical Trial Evaluating Imetelstat in Patients with Relapsed/Refractory Myelofibrosis

Retrieved on: 
Wednesday, December 6, 2023
Health, Stem Cells, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Safety, JAK, BAT, Gold, Corporation, Patient, Pharmacokinetics, Jaki, Survival, Imetelstat, Geron Corporation, Ruxolitinib, MF, Bone marrow, Pharmaceutical industry, Medicine

Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced achievement of fifty percent enrollment in the Phase 3 IMpactMF clinical trial investigating the Company’s first-in-class telomerase inhibitor, imetelstat, versus best available therapy (BAT) in patients with relapsed/refractory myelofibrosis (MF).

Key Points: 
  • Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced achievement of fifty percent enrollment in the Phase 3 IMpactMF clinical trial investigating the Company’s first-in-class telomerase inhibitor, imetelstat, versus best available therapy (BAT) in patients with relapsed/refractory myelofibrosis (MF).
  • “This is the first Phase 3 trial to evaluate overall survival as a primary endpoint in relapsed/refractory MF and is also the first Phase 3 trial investigating a telomerase inhibitor in this patient population.
  • “There is therefore a very pressing need for treatments that can improve survival in relapsed/refractory MF.
  • A median OS of 29.9 months in imetelstat 9.4 mg/kg arm was observed in IMbark Phase 2, compared to 14-16 months median OS for historical controls for these JAKi relapsed/refractory MF patients.

MorphoSys’ Phase 3 Study of Pelabresib in Myelofibrosis Demonstrates Statistically Significant Improvement in Spleen Volume Reduction and Strong Positive Trend in Symptom Reduction

Retrieved on: 
Monday, November 20, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, FSE, Ruxolitinib, MorphoSys, Patient, TSS, BET, JAK, Pharmaceutical industry, Medical imaging

MANIFEST-2 met its primary endpoint, as the combination therapy demonstrated a statistically significant and clinically meaningful improvement in the proportion of patients achieving at least a 35% reduction in spleen volume (SVR35) at week 24.

Key Points: 
  • MANIFEST-2 met its primary endpoint, as the combination therapy demonstrated a statistically significant and clinically meaningful improvement in the proportion of patients achieving at least a 35% reduction in spleen volume (SVR35) at week 24.
  • The key secondary endpoints assessing symptom improvement – proportion of patients achieving at least a 50% reduction in total symptom score (TSS50) and absolute change in total symptom score (TSS) from baseline at week 24 – showed a strong positive trend favoring the pelabresib and ruxolitinib combination.
  • “Importantly, we saw significant symptom improvements for the vast majority of patients in the study.
  • “The pelabresib and ruxolitinib combination therapy significantly reduced spleen volume – the best prognostic indicator we have at our disposal for long-term myelofibrosis patient outcomes.