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Clinical Trial News

ProKidney's Rilparencel Shows 78% Improvement in Kidney Function Decline in Phase 2 CKD Trial

  • ProKidney reported statistically significant results from the Phase 2 REGEN-007 trial, showing rilparencel improved kidney function decline by 78% in patients with chronic kidney disease and diabetes.
  • The autologous cellular therapy demonstrated a clinically meaningful 4.6 mL/min/1.73m² per year improvement in eGFR slope (p<0.001) in patients receiving two scheduled injections.
  • No serious adverse events were observed, and the company plans to discuss using eGFR slope as a surrogate endpoint for accelerated FDA approval in an upcoming Type B meeting.

Proact: A Study of REACT in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney Disease

NCT05099770RecruitingPhase 3
Prokidney
Posted 1/5/2022

A Study of Renal Autologous Cell Therapy (REACT) in Participants With Type 2 Diabetes and Chronic Kidney Disease

NCT05286853RecruitingPhase 3
Prokidney
Posted 7/17/2024

Study of Renal Autologous Cell Therapy (REACT) in Subjects With Type 1 or 2 Diabetes and Chronic Kidney Disease (REGEN-007)

NCT05018416CompletedPhase 2
Prokidney
Posted 7/27/2021

Jasper Therapeutics' Briquilimab Shows 89% Complete Response Rate in CSU Despite Manufacturing Setbacks

Monoclonal Antibody
  • Briquilimab demonstrated remarkable efficacy in chronic spontaneous urticaria (CSU) with 89% of patients achieving complete response by week 2 in valid cohorts of the BEACON Phase 1b/2a trial.
  • Manufacturing defects in drug lot A349954 affected 10 of 13 patients in high-dose cohorts, resulting in minimal therapeutic response and delaying Phase 2b trials until mid-2026.
  • The anti-KIT monoclonal antibody offers potential advantages over current treatments with quarterly dosing versus Xolair's weekly or biweekly injections, targeting a $500M+ annual revenue opportunity in CSU.
  • Jasper has pivoted to focus solely on CSU development while halting asthma and SCID programs to preserve cash runway amid manufacturing challenges.

Duke Street Bio Receives FDA Fast Track Designation for Brain-Penetrating PARP1 Inhibitor DSB2455

  • Duke Street Bio has received FDA Fast Track designation for DSB2455, a next-generation PARP1-selective inhibitor designed to treat brain metastases from triple-negative breast cancer with BRCA1/2 or homologous recombination repair alterations.
  • The compound demonstrates brain penetrance and anti-tumor activity in preclinical models, addressing a significant unmet medical need where current therapeutic options are limited.
  • PARP1-selective inhibitors like DSB2455 are expected to offer a wider therapeutic window than earlier PARP inhibitors, potentially enabling broader use as monotherapy and in combination treatments.

Veeda Lifesciences Partners with Mango Sciences to Deploy AI-Powered Platform for Enhanced Clinical Trial Diversity

AIOncology
  • Veeda Lifesciences has announced an investment in Boston-based Mango Sciences to leverage AI capabilities for enhancing clinical trial speed, efficiency, and quality across its global network.
  • The partnership will deploy Mango Sciences' AI-powered Querent platform to automate patient identification with precision and expand reach across Europe, particularly focusing on oncology drug development.
  • The collaboration aims to improve diversity in clinical trials through broader representation of non-Caucasian populations, meeting regulatory expectations and pharmaceutical company demands.
  • The integration of Large Language Models and Generative-AI into the Querent platform will drive operational efficiencies and improve real-world evidence for better patient-drug matching.

USPTO Expands Fast-Track Patent Program to 20,000 Applications Annually as Accelerated Examination Program Ends

  • The USPTO increased the annual limit for prioritized examination requests from 15,000 to 20,000 applications effective July 8, 2025, providing expanded access to expedited patent processing.
  • The Accelerated Examination program for utility patent applications will be discontinued on July 10, 2025, with applicants redirected to the fee-based Track One program for expedited processing.
  • Track One applications achieve final disposition within 12 months compared to the standard 26.2-month average pendency, making it particularly valuable for life sciences companies seeking rapid patent protection.
  • The changes eliminate complex pre-examination requirements while maintaining age and health-based petition grounds without fees for qualifying inventors.

Morphic Medical Receives CE Mark for RESET Obesity Device, Targeting Alternative to Bariatric Surgery

  • Morphic Medical has obtained EU CE mark approval for RESET, a duodenal-jejunal bypass liner that mimics gastric bypass surgery effects for obesity and type 2 diabetes treatment.
  • A UK study demonstrated RESET achieved 17.4kg average weight reduction and 1.9% blood glucose improvement at three-year follow-up in patients with diabetes and obesity.
  • The device is positioned as a less-invasive bridge therapy for patients who have not responded to medications and are considering bariatric surgery.
  • RESET remains investigational in the US, with the pivotal STEP-1 trial enrolling 264 patients and completion planned for 2026.

RESET System Pivotal Trial (Rev F)

NCT04101669RecruitingNot Applicable
Morphic Medical Inc.
Posted 9/9/2019

Basilea Secures $39 Million BARDA Funding to Advance Novel Antifungal Candidates Fosmanogepix and BAL2062

Orphan Drug
  • Basilea Pharmaceutica received $39 million in additional BARDA funding to continue development of novel antifungals fosmanogepix and BAL2062, bringing total committed funding to $68 million under a potential $268 million agreement.
  • The funding will support ongoing Phase 3 trials for fosmanogepix in yeast infections and an upcoming Phase 3 study in mold infections, plus preparation for Phase 2 trials of BAL2062.
  • Both antifungal candidates feature novel mechanisms of action and target life-threatening infections in immunocompromised patients, addressing critical unmet medical needs in treating drug-resistant fungal infections.
  • Fosmanogepix has demonstrated activity against multi-drug-resistant strains including Candida auris and rare difficult-to-treat molds, while BAL2062 shows fungicidal activity against azole-resistant Aspergillus species.

Study to Assess Safety, Tolerability and Pharmacokinetics of APX001 Administered by Intravenous Infusion to Healthy Subjects

NCT02956499CompletedPhase 1
Basilea Pharmaceutica
Posted 5/24/2016

A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Candidemia and/or Invasive Candidiasis.

NCT05421858RecruitingPhase 3
Basilea Pharmaceutica
Posted 12/11/2024

A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Patients With Invasive Mold Infections.

NCT06925321RecruitingPhase 3
Basilea Pharmaceutica
Posted 8/26/2025

Navamedic Expands Into Addiction Treatment with NOK 225 Million Acquisition of DNE Pharma

  • Navamedic ASA has agreed to acquire Norwegian addiction treatment pharmaceutical company DNE Pharma for NOK 225 million, marking the company's strategic entry into the fast-growing addiction treatment market.
  • The acquisition includes key addiction treatment products such as Ventizolve (intranasal naloxone spray for opioid overdose reversal), Levopidon (levomethadone), and Metadon Dne (methadone) for opioid substitution therapy.
  • DNE Pharma generated NOK 62 million in net sales in 2024 and is expected to contribute approximately NOK 25 million in annual EBITDA, supporting Navamedic's goal of reaching NOK 1 billion in revenue.
  • The transaction will be financed through NOK 110 million in new debt from Nordea Bank and a partially underwritten rights issue of NOK 110-130 million, with completion expected on July 15, 2025.

Biorce Secures €5M to Transform Clinical Trials with AI-Driven Platform

AIOncology
  • Barcelona-based healthtech startup Biorce raised €5 million from Norrsken VC to scale its AI-driven platform that addresses clinical trial inefficiencies.
  • The company's Jarvis platform aims to reduce the 70% of clinical trials that face startup delays and 60% that require costly amendments averaging $250K-$450K each.
  • Biorce's AI technology has already streamlined over 300 clinical trial protocols across oncology and neurology, with potential to unlock $13-25 billion in industry value.
  • The funding will support US market expansion, team growth, and product development as the clinical trial market grows from $84 billion in 2024 to $150 billion by 2034.

Lobe Sciences Secures European Patent Protection for DHA-Based Sickle Cell Disease Treatment

Rare DiseaseRare Disease
  • Lobe Sciences has obtained European Unitary Patent EP4117446 validation, providing intellectual property protection across 17 EU member states for its DHA and egg yolk-based composition targeting Sickle Cell Disease.
  • The patent covers the formulation underlying Altemia® Medical Food, a first-in-class emulsified oral treatment designed to restore red blood cell membrane integrity and address long-chain fatty acid deficiencies in SCD patients.
  • This validation strengthens Lobe's intellectual property portfolio and enables broader commercialization of Altemia® across key European markets as part of the company's global expansion strategy.

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