Ulcerative colitis

Rani Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results; Provides Corporate Update

Retrieved on: 
Wednesday, March 22, 2023
Psoriatic arthritis, IPO, Partnership, Osteoporosis, Conference call, Part, Ulcerative colitis, Psoriasis, ET, Biosimilar, SAN, Longest increasing subsequence, HC, Research, FDA, Therapy, Ustekinumab, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Conference, Celltrion, Food, Safety, Pharmaceutical industry, Cryptocurrency

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Key Points: 
  • ET -
    SAN JOSE, Calif., March 22, 2023 (GLOBE NEWSWIRE) -- Rani Therapeutics Holdings, Inc. (“Rani Therapeutics” or “Rani”) (Nasdaq: RANI), a clinical-stage biotherapeutics company focused on the oral delivery of biologics and drugs, today reported financial results for the quarter and full year ended December 31, 2022 and provided a corporate update.
  • In December 2022, Rani announced topline results from Part 2 (repeat-dose portion) of the Phase 1 study of RT-102.
  • Rani Therapeutics is a clinical-stage biotherapeutics company focused on advancing technologies to enable the development of orally administered biologics and drugs.
  • Rani has successfully conducted several preclinical and clinical studies to evaluate safety, tolerability and bioavailability using RaniPill capsule technology.

Josep Bassaganya-Riera Launches NImmune Biopharma with Phase 3-Ready Clinical Candidate Omilancor for the Treatment of Ulcerative Colitis and Crohn’s Disease

Retrieved on: 
Wednesday, March 22, 2023
Health, FDA, Biometrics, Other Health, Clinical Trials, Pharmaceutical, Biotechnology, CD, Volunteering, FCP, RA, File, Lupus, IBD, NDA, Psoriasis, Pharmacokinetics, Toxicity, SLE, RB, LANCL2, Acquisition, UC, Ulcerative colitis, Patient, Standard of care, Rheumatoid arthritis, Autoimmune disease, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Safety, Pharmaceutical industry, Regulatory T cell

NIM-1324 is a Phase-2-ready biomarker-guided once-daily, oral therapeutic for the treatment of Systemic Lupus Erythematosus (SLE) and Rheumatoid Arthritis (RA).

Key Points: 
  • NIM-1324 is a Phase-2-ready biomarker-guided once-daily, oral therapeutic for the treatment of Systemic Lupus Erythematosus (SLE) and Rheumatoid Arthritis (RA).
  • “Our leadership team was instrumental in the creation of the LANCL immunoregulatory portfolio, and brings substantial experience working with omilancor specifically to NImmune.
  • Based on these findings and positive correspondence with the U.S. Food and Drug Administration (FDA), NImmune plans to initiate a Phase 3 randomized, placebo-controlled clinical trial in 2023.
  • An analysis of the Phase 2 data using the 440mg dose and the refined active disease population attained statistically significant clinical remission at week 12.

Organovo Announces FXR Program

Retrieved on: 
Tuesday, March 21, 2023
Tissue, FXR, Clinical trial, Disease, Ulcerative colitis, Inflammatory bowel disease, Phase 1, Patient, SAN, 2CB-Ind, FDA, Safety, Pharmaceutical industry

SAN DIEGO, March 21, 2023 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (NASDAQ: ONVO), a clinical stage biotechnology company that is focused on developing novel human therapies with demonstrated function in high fidelity three-dimensional (3D) tissues that recapitulate key aspects of human disease, today announced a clinical program for FXR 314, an FXR agonist that has completed initial clinical trials.

Key Points: 
  • SAN DIEGO, March 21, 2023 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (NASDAQ: ONVO), a clinical stage biotechnology company that is focused on developing novel human therapies with demonstrated function in high fidelity three-dimensional (3D) tissues that recapitulate key aspects of human disease, today announced a clinical program for FXR 314, an FXR agonist that has completed initial clinical trials.
  • FXR314 is a drug with safety and tolerability after daily oral dosing in Phase 1 and Phase 2 trials.
  • “We believe FXR314 to be a best-in-class FXR agonist with high potency and the potential to avoid dose-limiting toxicity issues found in other FXR-directed compounds,” said Keith Murphy, Organovo’s Founder and Executive Chairman.
  • The Company plans to give guidance on Phase 2 timelines after an internal determination of the best path forward.

Galapagos increases share capital through subscription right exercises

Retrieved on: 
Monday, March 20, 2023
Exercise, Galapagos NV, CET, Ulcerative colitis, EUR, Euronext, Therapy, Rheumatoid arthritis, D, Security (finance), Pharmaceutical industry

Mechelen, Belgium; 20 March 2023, 21.01 CET; regulated information – Galapagos NV (Euronext & NASDAQ: GLPG) announces a share capital increase arising from subscription right exercises.

Key Points: 
  • Mechelen, Belgium; 20 March 2023, 21.01 CET; regulated information – Galapagos NV (Euronext & NASDAQ: GLPG) announces a share capital increase arising from subscription right exercises.
  • Galapagos issued 61,560 new ordinary shares on 20 March 2023, for a total capital increase (including issuance premium) of EUR 1,769,850.00.
  • The total number of rights (formerly known as ‘warrants’) to subscribe to not yet issued securities conferring voting rights is (i) 10,731,149 subscription rights under several outstanding personnel subscription right plans, which equals 10,731,149 voting rights that may result from the exercise of those subscription rights, and (ii) 1 subscription right issued to Gilead Therapeutics to subscribe for a maximum number of shares that is sufficient to bring the shareholding of Gilead (and its affiliated companies) to 29.9% of the actually issued and outstanding shares after the exercise of such subscription right.
  • Galapagos does not have any convertible bonds or shares without voting rights outstanding.

Histogen Announces Issuance of US Patent Covering CTS-2090 Methods of Use

Retrieved on: 
Thursday, March 16, 2023
United States patent law, EVP, Ulcerative colitis, SAN, Patent, GI, Apoptosis, Human, Methicillin, MRSA, Pharmaceutical industry

SAN DIEGO, March 16, 2023 (GLOBE NEWSWIRE) -- Histogen Inc. (NASDAQ: HSTO), a clinical-stage therapeutics company on developing potential first-in-class clinical and preclinical small molecule pan-caspase and caspase selective inhibitors that protect the body’s natural process to restore immune function, today announced that the US Patent and Trademark Office (USPTO) has issued US Patent No. 11,579,703 titled “Caspase Inhibitors and Methods of Use Thereof.”

Key Points: 
  • 11,579,703 titled “Caspase Inhibitors and Methods of Use Thereof.”
    We believe this key patent provides broad coverage for Histogen’s portfolio of highly selective and orally active anti-inflammatory caspase inhibitors, including CTS-2090.
  • This patent includes information that CTS-2090 has demonstrated potent oral activity in a well characterized model of ulcerative colitis.
  • It builds upon Histogen’s growing proprietary caspase inhibitor portfolio that includes the US patent No.
  • This previously issued patent discloses a broad class of novel pan-caspase inhibitors with unique chemical properties,” stated Alfred Spada, EVP and Chief Scientific Officer of Histogen.

Comera Life Sciences Reports Financial Results for Fourth Quarter and Full Year 2022 and Recent Business Highlights

Retrieved on: 
Thursday, March 16, 2023
Research, SQ, Conference, Drug development, Quality of life, Inflammatory bowel disease, IBD, Caffeine, Ulcerative colitis, Half-life, Partnership, Biotechnology, Mab, Ipilimumab, Science, Patient, Toxicity, Animal, Regeneron Pharmaceuticals, Excipient, Safety, CMRA, IV, Pharmaceutical industry, Management, Cryptocurrency, Airline

WOBURN, Mass., March 16, 2023 (GLOBE NEWSWIRE) -- Comera Life Sciences Holdings, Inc. (Nasdaq: CMRA), a life sciences company developing a new generation of bio-innovative biologic medicines to improve patient access, safety, and convenience, today reported financial results for the fourth quarter and full year ended December 31, 2022, and provided a business update.

Key Points: 
  • “During 2022, Comera generated significant momentum, strengthening of the Company’s capabilities, team, proprietary pipeline, and executing pharmaceutical partnerships to drive value for Comera shareholders and our partners.
  • These accomplishments have positioned Comera to achieve substantial progress across our business,” said Jeffrey Hackman, Chairman and Chief Executive Officer of Comera.
  • Comera had $2.0 million in cash, cash equivalents, and restricted cash at December 31, 2022.
  • R&D expenses totaled $1.7 million for the year-ended December 31, 2022, compared to $1.8 million for the same period in 2021.

AltruBio Announces Panels and Presentations at Three March Healthcare Conferences

Retrieved on: 
Thursday, March 9, 2023
Doctor of Philosophy, Festival, Congress, Therapy, Ulcerative colitis, Conference, SAN, Pharmaceutical industry

SAN FRANCISCO, March 09, 2023 (GLOBE NEWSWIRE) -- AltruBio Inc. (“AltruBio” or “the Company”), a clinical stage biotech company dedicated to the development of novel therapeutics for the treatment of immunological diseases with high unmet medical needs, today announced that it will take part in three healthcare conferences in March, including Biologics Manufacturing Asia (March 15-16, 2023 in Singapore), Longwood Healthcare Leaders CEO Conference (March 15-17, 2023 in Miami) and Festival of Biologics World Antibody Congress USA (March 20-22, 2023 in San Diego).

Key Points: 
  • SAN FRANCISCO, March 09, 2023 (GLOBE NEWSWIRE) -- AltruBio Inc. (“AltruBio” or “the Company”), a clinical stage biotech company dedicated to the development of novel therapeutics for the treatment of immunological diseases with high unmet medical needs, today announced that it will take part in three healthcare conferences in March, including Biologics Manufacturing Asia (March 15-16, 2023 in Singapore), Longwood Healthcare Leaders CEO Conference (March 15-17, 2023 in Miami) and Festival of Biologics World Antibody Congress USA (March 20-22, 2023 in San Diego).
  • AltruBio CEO and President Judy Chou, Ph.D. will share her view in biological drug development, discuss the approaches to address unmet medical needs, and provide a corporate overview highlighting recent progress including the ongoing Phase 1 trial of the company’s subcutaneously administered immune checkpoint enhancer ALTB-268 for the treatment of ulcerative colitis.
  • Date and Time: Tuesday, March 14, 2023 at 6:05-6:30 pm PT | Wednesday, March 15, 2023 at 10:05-10:30 am Singapore Time
    Date and Time: Tuesday, March 14, 2023 at 5:00-5:45 pm PT | Wednesday, March 15, 2023 at 9:00-9:45 am Singapore Time
    Date and Time: Monday, March 20, 2023 at 2:00 pm PT in San Diego, CA

Ribon Therapeutics Doses First Patient in Phase 1 Clinical Study with RBN-3143 in Patients with Moderate-to-Severe Atopic Dermatitis

Retrieved on: 
Thursday, March 9, 2023
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, Therapy, Patient, Atopic dermatitis, Pharmacokinetics, Disease, Skin, Asthma, Safety, Ulcerative colitis, Inflammation, Lung, Pharmaceutical industry

Ribon Therapeutics, a clinical-stage biotechnology company developing therapeutics to target stress support pathways, today announced dosing the first patient in the open-label cohort of patients with moderate-to-severe atopic dermatitis to measure the pharmacodynamic activity of RBN-3143 and evaluate the safety and preliminary efficacy of 28 days of administration of RBN-3143 in this target population.

Key Points: 
  • Ribon Therapeutics, a clinical-stage biotechnology company developing therapeutics to target stress support pathways, today announced dosing the first patient in the open-label cohort of patients with moderate-to-severe atopic dermatitis to measure the pharmacodynamic activity of RBN-3143 and evaluate the safety and preliminary efficacy of 28 days of administration of RBN-3143 in this target population.
  • “As a first-in-class, oral, small molecule inhibitor of PARP14, RBN-3143 has the potential to treat a range of inflammatory diseases, including but not limited to atopic dermatitis, asthma and ulcerative colitis.
  • Following the successful completion of the single and multiple ascending dose assessment in healthy subjects to assess safety and pharmacokinetics, we are pleased to be advancing this study into patients with moderate-to-severe atopic dermatitis, the first therapeutic area of focus for the RBN-3143 program,” said Prakash Raman, Ph.D., President and Chief Executive Officer, Ribon Therapeutics.
  • “RBN-3143 has demonstrated a favorable safety and pharmacokinetic profile in healthy subjects and we look forward to its evaluation in patients with moderate-to-severe atopic dermatitis and to demonstrate proof-of mechanism.”

MRM Health Completes Patient Recruitment in Ulcerative Colitis Study, Secures Financing and Provides Outlook for 2023

Retrieved on: 
Tuesday, March 7, 2023
University, Biotechnology, Education, Other Health, Health, General Health, Pharmaceutical, Other Science, Research, Science, Clinical Trials, DSM-IV codes, Cirrhosis, VIB, Non-alcoholic fatty liver disease, Therapy, CGMP, Type 2 diabetes, Partnership, Regression dilution, Patient, Disease, Neuroinflammation, United States patent law, Patent, Safety, MRM, UC, Fine chemical, Pharmaceutical industry, NAFLD, T2D, Spondyloarthropathy, PD, Ulcerative colitis

“2023 also started very promising as we reached a major milestone by completing early January patient recruitment in the Phase 2a study with MH002 in Ulcerative Colitis, while patient recruitment in our phase 2 study in Acute Pouchitis continues to progress.

Key Points: 
  • “2023 also started very promising as we reached a major milestone by completing early January patient recruitment in the Phase 2a study with MH002 in Ulcerative Colitis, while patient recruitment in our phase 2 study in Acute Pouchitis continues to progress.
  • MRM Health has now enrolled all 45 mild-to-moderate UC patients.
  • MRM Health has an ongoing corporate partnership with IFF since 2020, aiming to tackle a range of metabolic diseases.
  • As part of its ongoing program in T2D, MRM Health recently reached a next milestone upon successfully achieving preclinical development targets.

Clario, GI Reviewers and RSIP Vision Team Up to Present a New AI Solution to Advance Clinical Trials for Inflammatory Bowel Diseases

Retrieved on: 
Monday, March 6, 2023
Erythema, Inflammatory bowel disease, Fatigue, SAN, ECCO, Crohn's disease, Colonoscopy, Workflow, Disease, Kappa, Gastroenterology, Clinical trial, Patient, Inflammatory Bowel Diseases, Ulcerative colitis, Mayo, RSIP, IBD, AI, Knowledge, MES, Ulcer, Medicine, Automation, Acid erosion, Medical device, Clario Tech, Pharma, UC, Colitis

PHILADELPHIA and COPENHAGEN, Denmark and SAN MATEO, Calif. and BOSTON and JERUSALEM, March 6, 2023 /PRNewswire/ -- Clario, a leading healthcare research and technology company that generates the richest clinical evidence for the clinical trials industry and GI Reviewers, LLC Gastroenterology consultants and central readers, together with RSIP Vision, an experienced developer of groundbreaking AI technologies for medical imaging, today announced their new AI-based scoring system for inflammatory bowel diseases. The solution is expected to improve the reproducibility of colonoscopy video scoring, optimize workflow by shortening the time required for a human expert reader to score, and ultimately improve recruitment and reduce costs associated with clinical trials. Peer-reviewed results demonstrating the human-level performance of this innovative system were presented to the pharmaceutical and clinical trials industry community at the prestigious European Crohn's and Colitis (ECCO) conference this week.

Key Points: 
  • Innovative, human-level AI technology will improve efficiency and consistency of Inflammatory Bowel Disease (IBD) scoring, advancing clinical trials of novel treatments for these debilitating ailments.
  • Inflammatory bowel diseases (IBD) such as Ulcerative Colitis (UC) and Crohn's disease are mostly diagnosed by performing a colonoscopy.
  • Algorithm performance, as assessed by the Kappa metric, was found to be comparable to the performance of human reviewers.
  • Clario, GI Reviewers, and RSIP Vision continue to collaborate to bring the benefits of AI to all aspects of IBD clinical trials.