Proctitis

European Commission Approves Pfizer’s VELSIPITY® for Patients with Moderately to Severely Active Ulcerative Colitis

Retrieved on: 
Monday, February 19, 2024

Pfizer Inc. (NYSE: PFE) announced today that the European Commission (EC) has granted marketing authorization for VELSIPITY® (etrasimod) in the European Union to treat patients 16 years of age and older with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy, or a biological agent.

Key Points: 
  • Pfizer Inc. (NYSE: PFE) announced today that the European Commission (EC) has granted marketing authorization for VELSIPITY® (etrasimod) in the European Union to treat patients 16 years of age and older with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy, or a biological agent.
  • “For the 2.6 million people in Europe living with UC, the unpredictable physical, mental, and emotional impacts of the condition can be debilitating.
  • This authorization follows the recommendation for approval by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in December 2023.
  • Both studies achieved all primary and key secondary efficacy endpoints, with a favorable safety profile consistent with previous studies of VELSIPITY.

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.

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.

Direct Biologics Receives FDA Clearance to Initiate Phase 1b/2a Clinical Trial of ExoFlo™ in Patients with Medically Refractory Perianal Fistulizing Crohn’s Disease

Retrieved on: 
Wednesday, April 26, 2023

“The expansion of our inflammatory bowel disease clinical program into perianal fistulizing Crohn’s disease underscores our commitment to providing treatment options to a patient population that suffers from chronic inflammatory disease,” said Mark Adams, Chief Executive Officer of Direct Biologics.

Key Points: 
  • “The expansion of our inflammatory bowel disease clinical program into perianal fistulizing Crohn’s disease underscores our commitment to providing treatment options to a patient population that suffers from chronic inflammatory disease,” said Mark Adams, Chief Executive Officer of Direct Biologics.
  • The Phase 1b/2a clinical trial is designed to be a safety study with exploratory assessments of efficacy.
  • The trial will also evaluate the efficacy of ExoFlo in fistulizing subtypes, including patients with proctitis and numerous fistula tracts.
  • “FDA clearance to initiate this randomized trial of ExoFlo in perianal fistulizing Crohn’s disease marks a defining moment for patients suffering from this devastating phenotype that greatly diminishes quality of life.

Ulcerative Colitis Market Forecasts, Epidemiology & Pipeline Analysis 2022-2027: Focus on 8 Major Markets - United States, France, Germany, Italy, Spain, United Kingdom, China, and Japan - ResearchAndMarkets.com

Retrieved on: 
Tuesday, August 30, 2022

The ulcerative colitis epidemiology provides insights into the historical and current patient pools and forecasted trends for eight (8MM) major countries.

Key Points: 
  • The ulcerative colitis epidemiology provides insights into the historical and current patient pools and forecasted trends for eight (8MM) major countries.
  • The Ulcerative colitis epidemiology data are studied through all possible divisions to give a better understanding of the disease scenario in 8MM.
  • The increasing prevalence of ulcerative colitis is driving the growth of the ulcerative colitis drug market.
  • Launch of New Therapies: The USFDA approved small molecules such as Jyseleca (Filgotinib) and Rinvoq (Upadacitinib) in 2022 to treat moderate-to-severe ulcerative colitis.

Global Radiation Proctitis Market to 2030 - Industry Analysis, Size, Share, Growth, Trends and Forecasts - ResearchAndMarkets.com

Retrieved on: 
Tuesday, April 20, 2021

b'The "Radiation Proctitis Market - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 2020-2030" report has been added to ResearchAndMarkets.com\'s offering.\nThis report on the global radiation proctitis market studies the past as well as current growth trends and opportunities to gain valuable insights of these indicators for the market during the forecast period from 2020 to 2030.\nThe report provides the revenue of the global radiation proctitis market for the period 2018 - 2030, considering 2019 as the base year and 2030 as the forecast year.

Key Points: 
  • b'The "Radiation Proctitis Market - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 2020-2030" report has been added to ResearchAndMarkets.com\'s offering.\nThis report on the global radiation proctitis market studies the past as well as current growth trends and opportunities to gain valuable insights of these indicators for the market during the forecast period from 2020 to 2030.\nThe report provides the revenue of the global radiation proctitis market for the period 2018 - 2030, considering 2019 as the base year and 2030 as the forecast year.
  • Furthermore, the report sheds light on the changing competitive dynamics in the global radiation proctitis market.
  • These indices serve as valuable tools for existing market players as well as for entities interested in participating in the global radiation proctitis market.
  • The next section of the global radiation proctitis market report highlights the USPs, which include epidemiology analysis, regulatory scenario, key industry events, technological advancements, and key success factors of top players operating in the global radiation proctitis market.\nThe report also delves into the competition landscape of the global radiation proctitis market.

Innovation Pharmaceuticals Announces Publication of Peer-Reviewed Scientific Article in the Journal Viruses on the Anti-SARS-CoV-2 Properties of Brilacidin

Retrieved on: 
Tuesday, March 2, 2021

Brilacidin, a versatile compound with broad therapeutic potential, is in a new chemical class called defensin-mimetics.

Key Points: 
  • Brilacidin, a versatile compound with broad therapeutic potential, is in a new chemical class called defensin-mimetics.
  • The Company plans to advance Brilacidin oral rinse into Phase 3 development, subject to available financial resources.
  • Positive results were also observed in a Phase 2 Proof-of-Concept trial treating patients locally with Brilacidin for Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS).
  • Brilacidin for UP/UPS was licensed to Alfasigma S.p.A. in July 2019, who have recently completed a Phase 1 study with their formulation.

Innovation Pharma Provides Study Details for Ongoing Phase 2 Clinical Trial of Brilacidin in Hospitalized COVID-19 Patients

Retrieved on: 
Friday, February 26, 2021

The Company plans to advance Brilacidin oral rinse into Phase 3 development, subject to available financial resources.

Key Points: 
  • The Company plans to advance Brilacidin oral rinse into Phase 3 development, subject to available financial resources.
  • Positive results were also observed in a Phase 2 Proof-of-Concept trial treating patients locally with Brilacidin for Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS).
  • Brilacidin for UP/UPS was licensed to Alfasigma S.p.A. in July 2019, who have recently completed a Phase 1 study with their formulation.
  • Brilacidin, based on promising in vitro antiviral activity against SARS-CoV-2, is being evaluated in a Phase 2 clinical trial as a potential treatment for COVID-19.

Innovation Pharmaceuticals’ Phase 2 Clinical Trial of Brilacidin for Treating COVID-19 Scheduled to Begin Next Week

Retrieved on: 
Friday, January 29, 2021

Brilacidin, a versatile compound with broad therapeutic potential, is in a new chemical class called defensin-mimetics.

Key Points: 
  • Brilacidin, a versatile compound with broad therapeutic potential, is in a new chemical class called defensin-mimetics.
  • The Company plans to advance Brilacidin oral rinse into Phase 3 development, subject to available financial resources.
  • Positive results were also observed in a Phase 2 Proof-of-Concept trial treating patients locally with Brilacidin for Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS).
  • Brilacidin for UP/UPS was licensed to Alfasigma S.p.A. in July 2019, who have recently initiated a Phase 1 study with their formulation.

Innovation Pharmaceuticals Announces Overseas Regulatory Filing Submitted For COVID-19 Clinical Study

Retrieved on: 
Monday, November 16, 2020

Innovation Pharmaceuticals Inc. (IPIX) is a clinical stage biopharmaceutical company developing a world-class portfolio of innovative therapies addressing multiple areas of unmet medical need, including inflammatory diseases, cancer, infectious diseases, and dermatologic diseases.

Key Points: 
  • Innovation Pharmaceuticals Inc. (IPIX) is a clinical stage biopharmaceutical company developing a world-class portfolio of innovative therapies addressing multiple areas of unmet medical need, including inflammatory diseases, cancer, infectious diseases, and dermatologic diseases.
  • Brilacidin, a versatile compound with broad therapeutic potential, is in a new chemical class called defensin-mimetics.
  • The Company plans to advance Brilacidin oral rinse into Phase 3 development, subject to available financial resources.
  • Positive results were also observed in a Phase 2 Proof-of-Concept trial treating patients locally with Brilacidin for Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS).