EQ Inc | MedPath

Lupus Nephritis Market Expected to Grow as Novel Therapies Enter Clinical Trials

14 days ago

• The global lupus nephritis market is projected to grow significantly by 2034, with the United States accounting for over 80% of the current $1.12 billion market share across major regions. • Several innovative therapies are advancing through clinical trials, including CAR-T cell treatments from companies like Allogene Therapeutics, Adicet Bio, and Caribou Biosciences, which received FDA Fast Track designations. • Key pharmaceutical players including Aurinia Pharmaceuticals, AstraZeneca, and Roche are developing treatments such as voclosporin, anifrolumab, and obinutuzumab to address the significant unmet needs in lupus nephritis management.

FDA Approves ORLYNVAH™: First New Oral Treatment for Uncomplicated UTIs in 25 Years

3 months ago

• Iterum Therapeutics receives FDA approval for ORLYNVAH™, marking the first branded uncomplicated UTI treatment to enter the U.S. market in over 25 years and the first oral penem antibiotic approved in the country. • The drug demonstrates significant potential against multi-drug resistant pathogens, specifically targeting Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis in adult women with limited treatment options. • Iterum reports $24.1 million in cash reserves as of December 2024, with funding projected to sustain operations into the second half of 2025 while pursuing pre-commercialization activities.

Itolizumab Shows Promising Results in Phase 2 Ulcerative Colitis Trial, Matching Adalimumab Efficacy

4 months ago

• Itolizumab demonstrated a 23.3% clinical remission rate in moderate to severe ulcerative colitis patients after 12 weeks, comparable to adalimumab's 20.0% and superior to placebo's 10.0%. • The novel CD6-ALCAM pathway targeting drug achieved 16.7% endoscopic remission, matching adalimumab's performance while maintaining a favorable safety profile. • The Phase 2 trial involved 90 biologic-naïve patients, with itolizumab showing efficacy despite having more severe cases in its treatment arm compared to control groups.

Graves' Disease and Graft-versus-Host Disease: Pipeline Therapeutics Update

6 months ago

• Several companies are actively developing novel therapies for Graves' Disease, targeting mechanisms like IGF-1R and FcRn. • Clinical trials are underway for Batoclimab (Phase III), VRDN-001 (Phase III), and Linsitinib (Phase II/III) to address Graves' Disease. • The Graft-versus-Host Disease pipeline includes over 65 drugs in development, with companies like MaaT Pharma and Syndax Pharmaceutical leading the way. • Therapies like MaaT013 and axatilimab are in advanced stages of clinical trials, offering potential new treatments for Graft-versus-Host Disease.

T-Cell Malignancy Pipeline Shows Promise with Novel Therapies and Approvals

7 months ago

• The T-cell malignancies market is experiencing growth driven by increased incidence, treatment advancements, and strategic biopharma partnerships. • Several companies, including Corvus Pharmaceuticals and Kymera Therapeutics, are advancing novel therapies through clinical trials, targeting unmet needs in T-cell lymphomas. • Regulatory milestones, such as FDA Fast Track Designation for soquelitinib and EMA Orphan Drug Designation for SLS009, are accelerating the development of new treatments. • Research and development efforts, highlighted by presentations at major conferences like EHA, are yielding promising clinical data for drugs like KT-333.

Tulisokibart Shows Promise in Treating Moderate to Severe Ulcerative Colitis

8 months ago

• A Phase 2 trial of tulisokibart, an anti-TL1A monoclonal antibody, demonstrated superior efficacy compared to placebo in inducing clinical remission in patients with moderate to severe ulcerative colitis. • The study utilized a genetic-based diagnostic test to identify patients more likely to respond to tulisokibart, showing improved remission rates in this subgroup. • Tulisokibart modulates inflammation and the body's anti-inflammatory mechanisms, offering a novel approach compared to existing IBD treatments that can exacerbate inflammation. • The safety profile of tulisokibart appeared comparable to placebo, with similar rates of adverse events, supporting its potential as a valuable new treatment option.

Vivtex and Equillium Collaborate on Oral Biologic for GI Inflammation

8 months ago

• Vivtex and Equillium have entered a research agreement to develop an oral formulation of EQ302, a bispecific peptide therapy targeting IL-15 and IL-21. • Vivtex will apply its GI-ORIS™ technology to enhance the oral bioavailability of EQ302 for treating gastrointestinal inflammation. • Equillium plans to initiate a Phase 1 clinical trial of the oral EQ302 formulation in the second half of 2025. • The collaboration aims to provide a more convenient and effective treatment option for patients with inflammatory bowel disease and other GI disorders.