CDAI

Anaptys Announces Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Monday, March 11, 2024
Therapy, SAN, Ulcerative colitis, Week, CDAI, B cell, Atopic dermatitis, BTLA, Q2, PD-1, Inflammation, Annual general meeting, AAD, UC, Idealized cognitive model, Rheumatoid arthritis, IGA, Patient, BDCA2, IND

“We will have a number of important events in 2024 including the top-line data readout of ANB032's Phase 2b trial in atopic dermatitis by year end,” adds Faga. “We also plan to move our third and fourth ICMs -- ANB033, our anti-CD122 antagonist, and ANB101 -- into the clinic this year, with IND filings planned for Q2 and H2, respectively.”

Key Points: 
  • “Enrollment is ongoing in three global Phase 2 trials for ANB032, our BTLA agonist, in atopic dermatitis and rosnilimab, our PD-1 agonist, in rheumatoid arthritis and ulcerative colitis.
  • The decrease relates primarily to cash used for operating activities and the $50 million stock repurchase program.
  • The change is due primarily to increased royalties recognized for sales of Jemperli offset by one development milestone achieved for cobolimab in 2022.
  • Acquired in-process research and development of $7.3 million for the three and twelve months ended December 31, 2023 related to the exclusive licensing agreement with Centessa Pharmaceuticals.

Ventyx Biosciences Reports Clinical Data for its NLRP3 Inhibitor Portfolio and Provides Pipeline Updates at Virtual Investor Event

Retrieved on: 
Monday, March 11, 2024
SAN, Ulcerative colitis, Week, CDAI, IC50, Solipsism syndrome, Peripheral, Obesity, Cerebrospinal fluid, Cardiovascular disease, Treatment, MACE, NLRP3, Volunteering, Inflammation, Modulation, QD, Safety, Biomarker, UC, CAPS, Pharmacokinetics, Webcast, Patient, Molina Healthcare, TYK2, CSF, PIPE, Plasma, FCAS, Risk, Pharmaceutical industry

SAN DIEGO, March 11, 2024 (GLOBE NEWSWIRE) -- Ventyx Biosciences, Inc. (Nasdaq: VTYX) (“Ventyx”), a clinical-stage biopharmaceutical company focused on advancing novel oral therapies that address a broad range of inflammatory diseases with significant unmet medical need, will provide clinical and pipeline updates today during its virtual investor event.

Key Points: 
  • We believe these data support the potential for VTX3232 to emerge as a best-in-class CNS-penetrant NLRP3 inhibitor for the treatment of neuroinflammatory diseases.
  • We believe these data establish compelling clinical proof of concept for our peripheral NLRP3 inhibitor VTX2735.
  • At our virtual investor event, we will present data from the ongoing Phase 2 open-label extension.
  • Ventyx will host a virtual investor event today, Monday, March 11, 2024 from 11:00AM to 12:30PM ET.

Ventyx Biosciences Reports Fourth Quarter and Full Year 2023 Financial Results and Highlights Recent Corporate Progress

Retrieved on: 
Tuesday, February 27, 2024
SAN, Ulcerative colitis, Quarter, Week, CDAI, Peripheral, Blood, Obesity, ALS, Research and development, Cryopyrin-associated periodic syndrome, NLRP3, Volunteering, Inflammation, Modulation, Multiple sclerosis, Rheumatology, Safety, UC, CAPS, CNS, Administration, Pharmacokinetics, Patient, TYK2, FCAS, G&A, Ulcer, Pharmaceutical industry

SAN DIEGO, Feb. 27, 2024 (GLOBE NEWSWIRE) -- Ventyx Biosciences, Inc. (Nasdaq: VTYX) (“Ventyx”), a clinical-stage biopharmaceutical company focused on advancing novel oral therapies that address a broad range of inflammatory diseases with significant unmet medical need, today announced financial results for the fourth quarter and full year ended December 31, 2023, and highlighted recent pipeline and business progress.

Key Points: 
  • Fourth Quarter and Full Year 2023 Financial Results:
    Cash Position: Cash, cash equivalents and marketable securities were $252.2 million as of December 31, 2023.
  • Research and Development (R&D) expenses: R&D expenses were $42.0 million for the fourth quarter of 2023, compared to $30.2 million for the fourth quarter of 2022.
  • General and Administrative (G&A) expenses: G&A expenses were $8.3 million for the fourth quarter of 2023, compared to $8.4 million for the fourth quarter of 2022.
  • Net loss: Net loss was $46.8 million for the fourth quarter of 2023, compared to $35.2 million for the fourth quarter of 2022.

Media Advisory - Minister Sajjan to deliver remarks at the annual Ottawa Conference on Security and Defence

Retrieved on: 
Thursday, March 7, 2024
Privy council, CDAI, Keynote, Emergency, Security, Conference

OTTAWA, ON, March 7, 2024 /CNW/ - The Honourable Harjit S. Sajjan, President of the King's Privy Council for Canada and Minister of Emergency Preparedness and Minister responsible for the Pacific Economic Development Agency of Canada, will deliver the opening Keynote Address on Day 2 of the 92nd annual Ottawa Conference on Security and Defence, hosted by the Conference of Defence Associations Institute (CDAI).

Key Points: 
  • OTTAWA, ON, March 7, 2024 /CNW/ - The Honourable Harjit S. Sajjan, President of the King's Privy Council for Canada and Minister of Emergency Preparedness and Minister responsible for the Pacific Economic Development Agency of Canada, will deliver the opening Keynote Address on Day 2 of the 92nd annual Ottawa Conference on Security and Defence, hosted by the Conference of Defence Associations Institute (CDAI).

Anaptys Announces Third Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Thursday, November 2, 2023
Week, Therapy, CDAI, BTLA, Atopic dermatitis, PD-1, Patient, Rheumatoid arthritis, RA, SAN, Ulcerative colitis, Pharmaceutical industry

Initiated a global Phase 2b trial to treat rheumatoid arthritis (RA) with rosnilimab, our PD-1 agonist

Key Points: 
  • Initiated a global Phase 2b trial to treat rheumatoid arthritis (RA) with rosnilimab, our PD-1 agonist
    SAN DIEGO, Nov. 02, 2023 (GLOBE NEWSWIRE) -- AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, today reported operating results for the third quarter ended September 30, 2023 and provided a business update.
  • “We’ve made strong progress this quarter executing against our multi-year plan to develop best-in-class immune cell modulators to drive differentiated clinical outcomes in heterogeneous, systemic autoimmune and inflammatory diseases,” said Daniel Faga, president and chief executive officer of Anaptys.
  • The decrease relates to cash used for the $50 million stock repurchase program and operating activities.
  • The increase was due primarily to manufacturing and development costs for rosnilimab, ANB032 and ANB033.

Data Presented at UEG Week 2023 Further Support the Potential of Celltrion’s Investigational Subcutaneous Infliximab CT-P13 SC in the Treatment of Inflammatory Bowel Disease

Retrieved on: 
Monday, October 16, 2023
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, Incidence, European Commission, Health care, United European Gastroenterology, Northwestern Medicine, Feinberg School of Medicine, Mayo, CD, Aes, MD, BLA, IBD, Crohn's disease, Safety, Medicine, Ulcerative colitis, Patient, FDA, Biologics license application, Celltrion, CDAI, Maintenance, Infliximab, Inflammatory bowel disease, UEG, Infection, Pharmaceutical industry, Medical imaging, UC

The proportion of patients who experienced adverse events (AEs), serious AEs, infection in the SC infliximab and placebo groups were generally comparable.

Key Points: 
  • The proportion of patients who experienced adverse events (AEs), serious AEs, infection in the SC infliximab and placebo groups were generally comparable.
  • If approved by the FDA, CT-P13 SC would be the first subcutaneous formulation of infliximab.
  • Post-hoc analyses of the LIBERTY-CD and LIBERTY-UC studies were presented as posters at UEG Week 2023.
  • The first post-hoc analysis examined the possible use of SC infliximab treatment without immunosuppressants and the second evaluated dose escalation in patients with loss of treatment response.

AbbVie's SKYRIZI® (risankizumab) Versus STELARA® (ustekinumab) Head-to-Head Study in Crohn's Disease Meets All Primary and Secondary Endpoints

Retrieved on: 
Sunday, October 15, 2023
NYSE, United European Gastroenterology, Ustekinumab, Burrill Bernard Crohn, ABBV, Crohn's disease, Safety, AbbVie, NORTH, SC, IV, CDAI, Risankizumab, Inflammatory Bowel Diseases, UEG, Patient, Pharmaceutical industry, Medical imaging

SEQUENCE, a Phase 3 head-to-head study, compared risankizumab to ustekinumab for the treatment of adult patients with moderately to severely active Crohn's disease who have failed one or more anti-TNFs1

Key Points: 
  • SEQUENCE, a Phase 3 head-to-head study, compared risankizumab to ustekinumab for the treatment of adult patients with moderately to severely active Crohn's disease who have failed one or more anti-TNFs1
    Risankizumab showed superiority versus ustekinumab for all ranked secondary endpoints, including achievement of clinical remissiona at week 48, achievement of endoscopic responsec at week 48 and 24, achievement of steroid-free endoscopic remissiond at week 48 and achievement of steroid-free clinical remissione at week 481
    Safety results were consistent with the overall safety profile of risankizumab, with no new safety risks identified
    NORTH CHICAGO, Ill., Oct. 15, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) today presented positive results from the head-to-head Phase 3 SEQUENCE study that evaluated the efficacy and safety of risankizumab (SKYRIZI®, 600 mg intravenous [IV] at week 0, 4 and 8 and 360 mg subcutaneous [SC] starting at week 12 and every 8 weeks thereafter) compared to ustekinumab (STELARA®, IV dose at week 0 and 90 mg SC every 8 weeks thereafter) in patients with moderately to severely active Crohn's disease who have failed one or more anti-TNFs.1 The data were presented at the United European Gastroenterology (UEG) Week 2023, October 14-17.
  • "At AbbVie, we are committed to developing medicines and generating evidence that advance care for people living with immune-mediated conditions, including inflammatory bowel diseases," said Roopal Thakkar, M.D., senior vice president, development and regulatory affairs and chief medical officer, AbbVie.
  • "Results such as these not only help differentiate SKYRIZI as an option for managing Crohn's disease, but also may help to evolve the field by further informing on therapeutic strategies for patients."
  • The SEQUENCE study included two sequentially tested primary endpoints:
    The results of the first primary endpoint, clinical remission (CDAI The results of the second primary endpoint, endoscopic remission (Simple Endoscopic Score for Crohn's disease [SES-CD] ≤4 and at least a 2-point reduction versus baseline and no sub-score greater than 1 in any individual component) at week 48 demonstrated superiority with risankizumab compared to ustekinumab with remission rates of 32% in risankizumab group and 16% in ustekinumab group (p Additionally, risankizumab demonstrated superiority compared to ustekinumab for all ranked secondary endpoints, including achievement of clinical remission at week 48, achievement of endoscopic response at week 48 and 24, achievement of steroid-free endoscopic remission at week 48, and achievement of steroid-free clinical remission at week 48.1

SetPoint Medical Announces Publication of Data for Neuroimmune Modulation to Treat Crohn's Disease in Journal of Crohn's and Colitis

Retrieved on: 
Tuesday, October 3, 2023
Biotechnology, Health, Clinical Trials, Medical Devices, RA, Defecation, TNF, Gastrointestinal tract, Vagus nerve, Serum, Disease, Quality of life, Vagus nerve stimulation, Inflammation, Doctor of Philosophy, Rheumatoid arthritis, Inflammatory bowel disease, Crohn's disease, Journal, Medical director, MD, Patient, Gastroenterology, CDAI, Safety, Northwestern, Pharmaceutical industry, Colitis, Medicine

SetPoint Medical , a clinical-stage healthcare company dedicated to patients with chronic autoimmune diseases, today announced the publication of data from a multicenter European clinical trial evaluating the safety and efficacy of neuroimmune modulation in patients with treatment-refractory Crohn’s disease in the Journal of Crohn’s and Colitis .

Key Points: 
  • SetPoint Medical , a clinical-stage healthcare company dedicated to patients with chronic autoimmune diseases, today announced the publication of data from a multicenter European clinical trial evaluating the safety and efficacy of neuroimmune modulation in patients with treatment-refractory Crohn’s disease in the Journal of Crohn’s and Colitis .
  • The pilot study demonstrated that neuroimmune modulation via vagus nerve stimulation resulted in a clinically meaningful reduction in disease activity and improved quality of life.
  • “Crohn’s disease is a debilitating inflammatory condition affecting the gastrointestinal tract.
  • “We are committed to advancing the potential of neuroimmune modulation for patients suffering from various chronic autoimmune conditions,” said Murthy V. Simhambhatla, Ph.D., president and CEO of SetPoint Medical.

XBiotech Announces First Patient Begins Novel Natrunix Therapy in Phase II Rheumatoid Arthritis (RA) Clinical Trial

Retrieved on: 
Tuesday, August 8, 2023
NRS, ACR, APG system, RA, Arthritis, Interleukin-1 family, Enterprise master patient index, Arthritis Foundation, Quality of life, American College of Rheumatology, Tenderness, Inflammation, Person, Rheumatoid arthritis, CDC, Pain, Joint, American College, Phase, CDAI, MTX, Safety, Pharmaceutical industry

AUSTIN, Texas, Aug. 08, 2023 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ: XBIT) today began treating the first patient in a phase II, double-blind, placebo-controlled, randomized clinical study to evaluate Natrunix as a new treatment for Arthritis.

Key Points: 
  • AUSTIN, Texas, Aug. 08, 2023 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ: XBIT) today began treating the first patient in a phase II, double-blind, placebo-controlled, randomized clinical study to evaluate Natrunix as a new treatment for Arthritis.
  • Natrunix blocks a key cause of inflammation involved in pain and joint destruction in rheumatoid arthritis (RA).
  • The primary endpoint of the Phase II is the American College of Rheumatology (ACR) 20% Response (ACR 20) rate at 12 weeks.
  • In addition, it is expected that 300,000 children will suffer from juvenile arthritis (Arthritis Foundation, 2023).

Telavant, a Roivant Company, Advances Inflammatory Bowel Disease Program with First Patient Dosed in Global Phase 2 Trial of Novel Anti-TL1A Antibody RVT-3101 in Crohn’s Disease

Retrieved on: 
Thursday, July 27, 2023
CD, Therapy, Inflammatory Bowel Diseases, IBD, Disease, Amsterdam, Inflammation, Fibrosis, Vant, Patient, CDAI, Safety, Pharmaceutical industry, UC, Roivant Sciences

The TAHOE study ( NCT05910528 ) is a global, randomized, double-blind study evaluating two doses of RVT-3101 given once-monthly in patients with moderate to severely active Crohn’s disease.

Key Points: 
  • The TAHOE study ( NCT05910528 ) is a global, randomized, double-blind study evaluating two doses of RVT-3101 given once-monthly in patients with moderate to severely active Crohn’s disease.
  • The primary and key secondary endpoints are the proportion of participants achieving clinical remission by Crohn's Disease Activity Index (CDAI) and the proportion of participants achieving endoscopic response at week 14.
  • This was the first-ever long-duration data reported for an anti-TL1A antibody.
  • Across all doses and patient groups, RVT-3101 was well tolerated and showed a favorable safety profile.