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Clinical Trial News

Juvenescence Acquires AI Drug Discovery Company Ro5 to Accelerate Age-Related Disease Pipeline

AIDrug Discovery
  • Juvenescence Limited has acquired Ro5 Inc., an AI drug discovery company with a proprietary Biomedical Knowledge Graph comprising over 85 million nodes and 400 million relationships.
  • The acquisition enhances Juvenescence's AI-enabled drug discovery capabilities and supports its strategic partnership with Abu Dhabi-based healthcare company M42.
  • The deal follows a $76 million Series B-1 financing round led by M42, with proceeds supporting clinical milestones across Juvenescence's pipeline targeting age-related diseases in cognition, cardio-metabolism, immunity, and cellular repair.

CONFIDENCE Study Shows Superior Kidney Protection with Combined Finerenone and SGLT-2 Inhibitor Therapy

  • The Phase II CONFIDENCE study demonstrated that simultaneous initiation of finerenone and empagliflozin achieved a 52% reduction in urine albumin-to-creatinine ratio (UACR) in patients with chronic kidney disease and type 2 diabetes.
  • Combined therapy showed 29% and 32% greater relative reduction in UACR compared to finerenone alone and empagliflozin alone, respectively, with benefits observed within 14 days.
  • The safety profile of simultaneous initiation was consistent with either agent alone, with less than 5% of patients experiencing adverse events leading to discontinuation.
  • Nearly three out of four patients achieved the clinically meaningful 30% UACR reduction threshold recommended by the American Diabetes Association for slowing kidney disease progression.

A Study to Learn How Well the Treatment Combination of Finerenone and Empagliflozin Works and How Safe it is Compared to Each Treatment Alone in Adult Participants With Long-term Kidney Disease (Chronic Kidney Disease) and Type 2 Diabetes

NCT05254002CompletedPhase 2
Bayer
Posted 6/23/2022

Study to Determine the Prevalence of Hypercortisolism in Patients With Type 2 Diabetes and Treatment With Korlym® (Mifepristone) (CATALYST)

NCT05772169CompletedPhase 4
Corcept Therapeutics
Posted 3/31/2023

ADJUnct Semaglutide Treatment in Type 1 Diabetes

NCT05537233CompletedPhase 2
Viral N. Shah
Posted 4/11/2023

Kiora Pharmaceuticals Partners with Senju for KIO-301 Development in Asian Markets Worth Over $110 Million

  • Kiora Pharmaceuticals has granted Senju Pharmaceutical an exclusive option for KIO-301 development and commercialization rights across key Asian markets including Japan and China, with a total potential deal value of $110 million plus royalties.
  • KIO-301 is a novel "molecular photoswitch" therapy currently in Phase 2 trials for inherited retinal diseases like retinitis pigmentosa, designed to restore light-sensing capabilities to retinal ganglion cells and potentially restore vision.
  • The partnership extends Kiora's global reach beyond its existing worldwide agreement with Théa Open Innovation, bringing the combined potential value of strategic partnerships to over $400 million.

BNT327/PM8002 Bispecific Antibody Shows Promising Activity in Unresectable Mesothelioma

  • A phase 2 trial demonstrated that BNT327/PM8002 plus chemotherapy achieved a 51.6% confirmed overall response rate in 31 patients with unresectable pleural and peritoneal mesothelioma.
  • Patients with peritoneal mesothelioma showed particularly strong responses with a 75% response rate and 100% disease control rate at median follow-up of 20.3 months.
  • The PD-L1/VEGF-A bispecific antibody showed manageable safety profile with no treatment-related deaths, though 93.5% of patients experienced grade 3/4 adverse events.
  • This represents one of the first trials to report immunotherapy combination results specifically in peritoneal mesothelioma patients.

Pembrolizumab in Patients With Advanced Malignant Pleural Mesothelioma

NCT02784171CompletedPhase 2
Canadian Cancer Trials Group
Posted 11/11/2016

A Study of PM8002 (Anti-PD-L1/VEGF) in Combination With Chemotherapy in Patients With ES-SCLC

NCT05844150Active, Not RecruitingPhase 2
Biotheus Inc.
Posted 6/1/2023

BEAT-meso: Bevacizumab and Atezolizumab in Malignant Pleural Mesothelioma

NCT03762018CompletedPhase 3
ETOP IBCSG Partners Foundation
Posted 4/30/2019

A Study of PM8002 Injection in Combination With Standard Chemotherapy as First Line Therapy in MPM

NCT05918107RecruitingPhase 2
Biotheus Inc.
Posted 8/13/2022

Study of Nivolumab Combined With Ipilimumab Versus Pemetrexed and Cisplatin or Carboplatin as First Line Therapy in Unresectable Pleural Mesothelioma Patients

NCT02899299CompletedPhase 3
Bristol-Myers Squibb
Posted 11/29/2016

Ocugen Secures $161M Gene Therapy Licensing Deal for OCU400 in Korean Market

  • Ocugen signed a binding term sheet with a Korean pharmaceutical leader for exclusive rights to OCU400, a novel modifier gene therapy for retinitis pigmentosa, potentially worth over $161 million.
  • The deal includes upfront fees and development milestones totaling up to $11 million, plus sales milestones of $1 million for every $15 million in net sales and 25% royalties on net sales.
  • OCU400 targets an estimated 15,000 individuals with retinitis pigmentosa in Korea and is currently advancing through Phase 3 clinical development with a target BLA filing in mid-2026.

Servier India Launches First-in-Class IDH1-Targeted Therapy Ivosidenib for Rare Blood and Bile Duct Cancers

Targeted TherapyDrug ApprovalOncologyRare DiseasePrecision Medicine
  • Servier India received CDSCO approval on May 14, 2025, to launch Ivosidenib (Tibsovo®), the first oral targeted therapy for IDH1-mutated acute myeloid leukemia and cholangiocarcinoma in India.
  • The therapy addresses a critical unmet medical need, as only 30-40% of AML patients in India receive adequate treatment and IDH1 mutations occur in approximately 7-14% of Indian AML patients.
  • Ivosidenib has already gained regulatory approval in over 42 countries, including FDA approval in 2019 and EMA approval in 2023 for specific patient populations.
  • The company is prioritizing accessibility and affordability through collaborations with healthcare providers, patient advocacy groups, and policymakers to ensure broader patient access across India.

FDA Approves Hundreds of Drugs Without Adequate Evidence of Effectiveness, Investigation Reveals

Drug Approval
  • A two-year investigation found that 73% of the 429 drugs approved by the FDA from 2013-2022 failed to meet the agency's four foundational standards for proving effectiveness.
  • Cancer drugs showed particularly concerning approval patterns, with only 2.4% of 123 cancer treatments meeting all four scientific criteria and 81% approved based on preliminary surrogate outcomes rather than survival data.
  • The investigation documented cases like Elmiron, which remained on market for nearly three decades despite causing blindness and having no proven efficacy, highlighting systemic failures in post-market confirmation studies.

Swiss Researchers Pioneer Multiomics-Based Cancer Treatment Predictions in First-of-Kind Clinical Study

Precision Medicine
  • Swiss researchers conducted the world's first clinical study using nine molecular biological technologies in parallel to predict optimal cancer treatments within four weeks, analyzing tumors from 116 melanoma patients.
  • The multiomics approach generated 43,000 data points per sample and provided treatment recommendations that were deemed helpful by treating specialists in 75% of cases.
  • Patients whose treatments were guided by tumor profiling data showed better response rates and progression-free survival compared to those who did not participate in the program.
  • The study represents a major advancement toward data-driven precision medicine, potentially enabling new clinical trials that test treatment predictions rather than individual drugs.

Fujirebio Partners with Stanford Medicine to Advance Ultrasensitive Infectious Disease Diagnostics

  • Fujirebio has announced a strategic collaboration with Stanford Medicine to accelerate research and innovation in infectious disease testing using ultrasensitive immunoassays.
  • The partnership will leverage single-molecule counting technology developed by Fujirebio's subsidiary Fluxus to improve test sensitivity for better clinical treatment decisions.
  • The collaboration brings together Stanford's Clinical Virology and Clinical Microbiology Laboratories with Fujirebio's global IVD expertise to address infectious disease threats worldwide.
  • Enhanced diagnostic sensitivity aims to accelerate studies toward therapeutics and preventive strategies against global infectious disease challenges.

Clarity Pharmaceuticals' 64Cu-SARTATE Shows Superior Lesion Detection in Phase II DISCO Trial for Neuroendocrine Tumors

Oncology
  • Clarity Pharmaceuticals' Phase II DISCO trial demonstrated that 64Cu-SARTATE detected 393-488 lesions compared to 186-265 lesions identified by standard 68Ga-DOTATATE imaging in 45 patients with neuroendocrine tumors.
  • The diagnostic imaging study confirmed 64Cu-SARTATE's safety and superior effectiveness in detecting NET lesions, substantially outperforming the current standard of care across multiple readers.
  • Clarity plans to initiate FDA discussions for a registrational Phase III study, positioning 64Cu-SARTATE as a potential best-in-class diagnostic agent that could improve clinical decision-making and treatment outcomes for NET patients.

A Diagnostic Imaging Study of 64Cu-SARTATE Using PET on Patients With Known or Suspected Neuroendocrine Tumors (DISCO)

NCT04438304CompletedPhase 2
Clarity Pharmaceuticals Ltd
Posted 3/2/2021

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