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Clinical Trial News

Synfini and Multispan Partner to Accelerate GPCR Drug Discovery Using AI and Automation

• Synfini, Inc. and Multispan have formed a strategic collaboration to co-discover and develop drug candidates targeting an undisclosed G protein-coupled receptor (GPCR), combining AI-driven chemistry with specialized GPCR biology expertise.
• The partnership leverages Synfini's AI Cloud Foundry platform to accelerate "design-make-test-analyze" cycles in molecular discovery, with early collaboration milestones already achieved according to Multispan's CEO.
• Beyond their initial target, the companies will make their combined technology platforms commercially available as a "one-stop shop" for accelerated drug discovery, offering AI, automation, and cutting-edge biology services to external clients.

Uni-Bio Science Group's Diquafosol Sodium Eye Drops Receives NMPA Approval for Dry Eye Syndrome Treatment in China

• Uni-Bio Science Group has received NMPA marketing approval for 金因康® (Diquafosol Sodium Eye Drops), addressing a market of approximately 360 million individuals with dry eye syndrome in China.
• The novel P2Y2 receptor agonist works by stimulating tear fluid and mucin secretion, offering improved tear layer normalization and corneal epithelial repair for patients with dry eye syndrome.
• China's dry eye syndrome market is projected to reach RMB 42 billion by 2030, growing at a CAGR of 28.4%, positioning 金因康® as a significant player in the rapidly expanding ophthalmology sector.

Biosergen's BSG005 Shows Promise Against Resistant Fungal Infections in Clinical Trial

• Biosergen has successfully completed the second patient cohort in its BSG005 proof-of-concept trial, with eight of ten patients showing clinical improvement against life-threatening fungal infections.
• BSG005, a next-generation polyene antifungal, demonstrated fungicidal activity against resistant strains, offering hope for patients who have failed standard treatments.
• The company plans to advance to a third cohort in Q4 2025 and is preparing for global Phase II/III trials, with regulatory discussions ongoing with India's CDSCO and the U.S. FDA.

Tecentriq and Avastin Combined with TACE Shows Significant Benefit in Unresectable Liver Cancer Trial

• The Phase III TALENTACE study demonstrated statistically significant improvement in TACE-progression-free survival for patients with unresectable hepatocellular carcinoma treated with Tecentriq, Avastin, and on-demand TACE.
• This landmark trial enrolled 342 patients across China and Japan, marking the first Phase III study in Asia showing TACE PFS benefit from combining immunotherapy and targeted therapy with TACE for unresectable HCC.
• Liver cancer remains the third leading cause of cancer-related death globally with rising mortality rates, with only 20% of patients surviving five years after diagnosis.

Bioxytran's Antiviral PHM23 Selected for University of Georgia's $100M Bird Flu Challenge Submission

• Bioxytran's antiviral compound PHM23 has been selected by the University of Georgia for inclusion in their grant submission to the USDA's $100 million Highly Pathogenic Avian Influenza Poultry Innovation Grand Challenge.
• The galectin antagonist technology behind PHM23 works by blocking viral spike proteins from attaching to host cells, demonstrating effectiveness against viruses similar to Bird Flu (H5N1) in laboratory studies.
• This recognition highlights PHM23's potential as a broad-spectrum antiviral that could help contain H5N1 outbreaks, potentially eliminating the need for mass culling and reducing billions in annual losses to the poultry industry.

Cipla Launches ZEMDRI (Plazomicin) in India to Combat Antimicrobial Resistance

• Cipla has introduced ZEMDRI (Plazomicin), a novel intravenous aminoglycoside treatment for complicated urinary tract infections (cUTI) including pyelonephritis in adult patients in India.
• The drug demonstrates promising activity against multi-drug resistant bacteria, including Carbapenem-resistant Enterobacteriaceae (CRE), addressing a critical challenge in managing resistant infections in India.
• ZEMDRI's approval was supported by the EPIC clinical trial, the first randomized controlled study of once-daily aminoglycoside therapy for cUTI treatment, with Cipla generating India-specific pathogen data to validate its effectiveness.

New Global Report Reveals Comprehensive Landscape of Chemotherapy-Induced Diarrhea Clinical Trials

• A new comprehensive report analyzing the global clinical trial landscape for Chemotherapy-Induced Diarrhea (CID) has been released, providing crucial insights for stakeholders in pharmaceutical R&D.
• The report details trial distribution across G7 and E7 countries, enrollment trends over five years, and classifies trials by phase, status, endpoint status, and sponsor type.
• Key companies involved in CID therapeutics include Novartis AG, Jaguar Health, and Guangzhou Zhiyi Biotechnology, with the report drawing data from over 80 clinical trial registries worldwide.

Worldwide Clinical Trials Joins WCG's Avoca Quality Consortium to Enhance Clinical Trial Standards

• Worldwide Clinical Trials has joined WCG's Avoca Quality Consortium (AQC), a collaborative network of over 200 life sciences companies focused on elevating clinical trial quality.
• The strategic partnership aims to enhance quality, efficiency, and regulatory compliance through industry collaboration and best practices, ultimately delivering faster and more reliable outcomes for customers.
• This membership aligns with Worldwide's commitment to quality assurance across its services, which include bioanalytical laboratory services, Phase I-IV clinical trials, and post-approval studies.

First Patient Dosed in Phase 2 OASIS Trial of TNX-102 SL for Acute Stress Reaction Following Trauma

• Tonix Pharmaceuticals has initiated dosing in the Phase 2 OASIS trial evaluating TNX-102 SL for reducing acute stress reaction severity and acute stress disorder frequency following traumatic events.
• The investigator-initiated study, sponsored by UNC and supported by a $3 million DoD grant, will enroll approximately 180 motor vehicle collision survivors through emergency departments across the U.S.
• TNX-102 SL, a sublingual cyclobenzaprine formulation that has shown promise in improving sleep quality in PTSD patients, addresses a significant unmet need as no medications currently exist for immediate post-trauma treatment.

Related Clinical Trials:

Mallia Therapeutics Advances Novel sCD83 Protein Treatment for Hair Loss

• Mallia Therapeutics has developed a topical treatment using soluble CD83 (sCD83) protein that demonstrates a dual mechanism of action for stimulating hair growth and forming new hair follicles.
• Unlike current treatments, sCD83 works locally without entering the bloodstream, potentially offering a safer alternative for both androgenetic alopecia and autoimmune-mediated alopecia areata.
• The company, co-founded by Prof. Dr. Alexander Steinkasserer who discovered sCD83 as an immune modulator, recently secured seed funding and plans to begin clinical trials within two years.
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