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Clinical Trial News

ProJenX and Unlearn Partner to Enhance ALS Trial with Digital Twin Technology

  • ProJenX collaborates with Unlearn to integrate AI-driven digital twins into the PRO-101 clinical trial for ALS, aiming to expedite the evaluation of prosetin.
  • Unlearn's ALS-DTG will generate digital twins of trial participants, serving as placebo counterparts to assess the impact of prosetin on clinical outcomes.
  • The partnership seeks to improve the efficiency and data-driven nature of ProJenX's clinical development program for prosetin, a MAP4K inhibitor.
  • The PRO-101 trial will evaluate clinical outcomes such as ALSFRS-R, Slow Vital Capacity, and plasma neurofilament light over a 52-week open-label extension.

A Study to Evaluate the Safety and Pharmacokinetics of Single and Multiple Doses of Prosetin in Healthy Volunteers and Participants With ALS

NCT05279755RecruitingPhase 1
ProJenX
Posted 2/26/2022

Vertex Highlights Vanzacaftor Triple Combination Data and Long-Term TRIKAFTA Impact at NACFC

  • Vertex Pharmaceuticals presented Phase 3 data on vanzacaftor/tezacaftor/deutivacaftor, showing non-inferiority to TRIKAFTA® in ppFEV1 and improved CFTR function.
  • Real-world evidence of TRIKAFTA® demonstrated sustained long-term benefits, including improved pancreatic function in young cystic fibrosis patients.
  • Health Canada accepted the New Drug Submission for vanzacaftor/tezacaftor/deutivacaftor for CF patients aged 6 years and older.

Dong-A ST's Hicardi+ H100 ECG Monitoring Platform Receives FDA Clearance

  • Dong-A ST's Hicardi+ H100, a patch-type ECG monitoring device, has received 510(k) clearance from the U.S. FDA, including its cloud-based software LiveStudio.
  • The device, developed by Meju, measures ECG and heart rate for long-term monitoring and is already used in Korea for cardiac disease screening.
  • This FDA approval follows certifications from Japan and Saudi Arabia, marking the first Korean smart patch with on-device machine learning for real-time biosignal analysis.
  • Dong-A ST plans to leverage this approval to accelerate global market expansion of its Hicardi solution in the digital healthcare sector.

ANI Pharmaceuticals Launches Ketoconazole Shampoo, 2% Following FDA Approval

  • ANI Pharmaceuticals has received FDA approval and launched Ketoconazole Shampoo, 2%, a generic version of Nizoral®, marking another limited competition product.
  • According to IQVIA data from July 2024, U.S. annual sales for Ketoconazole Shampoo, 2% total approximately $69.2 million, indicating a substantial market.
  • The launch aligns with ANI's strategic priority to consistently introduce new products that address patient needs, enhancing its generics business.
  • ANI's CEO, Nikhil Lalwani, expressed pride in the approval and commercialization, highlighting the R&D team's execution on key strategic priorities.

Hamlet BioPharma's Phase II Trial Shows Immunotherapy Matches Antibiotics for Cystitis

  • Hamlet BioPharma's Phase II trial demonstrates that anakinra immunotherapy achieves similar clinical outcomes to antibiotics in treating recurrent acute cystitis.
  • The study showed significant symptom reduction, fewer recurrences, and improved quality of life for patients treated with both anakinra and antibiotics.
  • This research supports immunotherapy as a potential alternative to antibiotics, addressing the growing threat of antibiotic resistance in urinary tract infections.
  • The findings suggest that immunomodulatory approaches targeting IL-1 may offer a non-antibiotic strategy for managing recurrent acute cystitis.

Tulisokibart Shows Promise in Treating Moderate to Severe Ulcerative Colitis

  • 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.

A Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Moderately to Severely Active Ulcerative Colitis (MK-7240-005)

NCT04996797CompletedPhase 2
Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Posted 7/14/2021

A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)

NCT06430801RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 6/5/2024

A Study to Evaluate Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderately to Severely Active Ulcerative Colitis (MK-7240-001)

NCT06052059RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 10/25/2023

Insilico Medicine Highlights AI-Driven Sustainability at NY Climate Week

• Insilico Medicine's CEO, Alex Zhavoronkov, presented AI-driven sustainability efforts at the AWS Climate Tech & AI Forum during NY Climate Week. • Insilico is exploring AI applications in agrochemistry, hydrogen storage, and CO2 capture, supported by partners like Syngenta and Saudi Aramco. • Insilico Medicine has nominated 19 preclinical candidates since 2021 and received IND approval for 9 molecules using its Pharma.AI platform. • Insilico's ISM001_055, an AI-discovered and designed drug, showed dose-dependent response in forced vital capacity (FVC) in a Phase IIa trial.

Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis (IPF)

NCT05938920Active, Not RecruitingPhase 2
InSilico Medicine Hong Kong Limited
Posted 6/19/2023

Innovent's Picankibart NDA Accepted in China for Plaque Psoriasis Treatment

  • Innovent's New Drug Application (NDA) for picankibart, an anti-IL-23p19 antibody, has been accepted by China's NMPA for treating moderate to severe plaque psoriasis.
  • Phase 3 trial data showed over 80% of subjects achieved PASI 90 after 16 weeks, with a convenient maintenance dosing interval of once every 12 weeks.
  • The NDA acceptance is based on the CLEAR-1 study, which demonstrated significantly higher rates of skin lesion clearance and improved quality of life compared to placebo.
  • Picankibart represents the first IL-23p19 antibody drug independently developed by a Chinese enterprise to submit an NDA in China.

A Study to Evaluate IBI112 in the Treatment of Psoriasis With Moderate to Severe Plaque Psoriasis

NCT05645627CompletedPhase 3
Innovent Biologics (Suzhou) Co. Ltd.
Posted 2/10/2023

Calliditas Therapeutics Pioneered Novel Endpoint for IgAN Drug Approval

  • Calliditas Therapeutics utilized a novel renal primary surrogate endpoint, proteinuria reduction, in a Phase III trial for IgA nephropathy (IgAN).
  • This approach enabled accelerated FDA approval for Calliditas's nephrology drug, a first in the field, setting a new precedent for rare renal disease treatments.
  • CEO Renee Aguiar-Lucander emphasized the importance of this novel endpoint in overcoming the challenges of traditional endpoints like kidney failure in rare diseases.
  • Calliditas has expanded globally, growing into a fully integrated biopharma company with a strong commercial presence in the U.S. and partnerships in key markets.

Inbiome's Molecular Culture ID Receives FDA Breakthrough Device Designation for Rapid Bacterial Diagnostics

  • Inbiome's Molecular Culture ID has received FDA Breakthrough Device Designation, recognizing its potential to transform infectious disease diagnostics.
  • The diagnostic test combines advanced chemistry and AI to rapidly detect over 200 bacterial species from bodily samples, providing same-day results.
  • Inbiome plans to introduce Molecular Culture ID to the U.S. market by early 2026, partnering with leading hospitals for implementation studies.
  • The technology aims to combat antimicrobial resistance by ensuring appropriate and effective antibiotic use through enhanced diagnostics.

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