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Acumen Pharmaceuticals Partners with JCR to Develop Enhanced Brain Delivery Therapy for Alzheimer's Disease

Monoclonal Antibody
  • Acumen Pharmaceuticals and JCR Pharmaceuticals have entered a strategic collaboration to combine Acumen's amyloid beta oligomer-selective antibody expertise with JCR's blood-brain barrier-penetrating J-Brain Cargo® technology for Alzheimer's disease treatment.
  • The partnership aims to develop Enhanced Brain Delivery therapy using sabirnetug or other novel antibodies, with preclinical candidate data expected in early 2026 and exclusive option rights for up to two development candidates.
  • Acumen's lead program sabirnetug is currently in Phase 2 ALTITUDE-AD trial with 542 enrolled patients, having demonstrated selective target engagement and statistically significant amyloid plaque reduction in Phase 1 studies.
  • JCR's transferrin receptor-targeting platform has already produced an approved therapy in Japan for lysosomal storage disorders, providing validated safety profile for the blood-brain barrier delivery technology.

A Study to Evaluate Efficacy and Safety of Intravenous Sabirnetug in Participants With Early Alzheimer's Disease (ALTITUDE-AD)

NCT06335173Active, Not RecruitingPhase 2
Acumen Pharmaceuticals
Posted 2/29/2024

4TEEN4's Procizumab Shows First-in-Human Evidence of Shock Reversal in Terminally Ill Patients

Monoclonal Antibody
  • 4TEEN4 Pharmaceuticals published first-in-human data showing procizumab, a monoclonal antibody targeting circulating dipeptidyl peptidase 3 (cDPP3), successfully reversed cardiogenic shock in three terminally ill patients within 48 hours.
  • The first-in-class antibody demonstrated safety and efficacy by blocking cDPP3 activity, restoring cardiovascular function and normalizing organ systems without adverse events in patients with multi-organ failure.
  • The company plans to initiate a Phase 2a clinical trial (PROCARD1) in mid-2025 across 11 European centers, followed by a global pivotal Phase 2/3 study in the second half of 2026.
  • Cardiogenic shock affects approximately one in three ICU patients and has mortality rates exceeding 50%, with no approved causal therapies currently available for this life-threatening condition.

Procizumab (PCZ; AK1967) in Critical Cardiovascular Care

NCT06832722RecruitingPhase 1
4TEEN4 Pharmaceuticals GmbH
Posted 7/13/2025

India's NPPA Sets Retail Prices for 71 Essential Drug Formulations Including Cancer and Diabetes Medications

Monoclonal Antibody
  • The National Pharmaceutical Pricing Authority (NPPA) has notified retail prices for 71 pharmaceutical formulations under the Drugs Prices Control Order (DPCO) 2013 to improve drug accessibility and affordability across India.
  • Key cancer treatment trastuzumab for injection (375 mg) has been priced at ₹11,966.64 per vial by Reliance Life Sciences, while various antibiotic combinations range from ₹447 to ₹1,036.60.
  • The pricing notification includes 25 anti-diabetes formulations containing empagliflozin combinations and other diabetes medications with sitagliptin as components.
  • Manufacturers are required to display price lists prominently at retail locations and online platforms to enable patients to verify compliance with NPPA-fixed prices.

Health Canada Extends Evkeeza Approval to Infants as Young as 6 Months for Rare Cholesterol Disorder

Drug ApprovalRare DiseaseMonoclonal Antibody
  • Health Canada has extended approval of Evkeeza (evinacumab) to treat children as young as 6 months old with homozygous familial hypercholesterolemia (HoFH), a devastating inherited cholesterol disorder.
  • HoFH affects 1 in 300,000 people globally and causes dangerously high LDL cholesterol levels exceeding 10 mmol/L, putting patients at risk for premature heart disease and cardiac events.
  • Evkeeza works by blocking the ANGPTL3 protein to reduce cholesterol levels and is administered monthly via infusion alongside low-fat diet and other cholesterol-lowering medications.
  • The therapy is now commercially available in multiple countries including Canada, the UK, US, Italy, Japan, and several European nations, with early access programs in 13 additional countries.

Efficacy and Safety of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia

NCT03399786CompletedPhase 3
Regeneron Pharmaceuticals
Posted 1/18/2018

Endometriosis Pain Treatment Pipeline Shows Mixed Results as NHS Approves First Daily Oral Therapy

Monoclonal AntibodyDrug Approval
  • The NHS in England has approved relugolix combination therapy as the first long-term daily oral treatment for endometriosis, expected to benefit around 1,000 women annually whose symptoms persist despite previous treatments.
  • Organon discontinued development of OG-6219 after the drug candidate failed its Phase 2 trial in July 2025, despite being acquired for $75 million and previously described as the company's "biggest potential opportunity."
  • Hope Medicine's HMI-115, a first-in-class monoclonal antibody targeting the prolactin receptor, reported positive interim Phase II results and received Breakthrough Therapy Designation from China's NMPA.
  • Multiple companies including TiumBio, Lisata Therapeutics, and Gynica are advancing novel therapeutic approaches through various clinical trial phases, representing diverse mechanisms of action for endometriosis pain management.

A Study of E7386 in Combination With Other Anticancer Drug(s) in Participants With Solid Tumor

NCT04008797RecruitingPhase 1
Eisai Inc.
Posted 7/11/2019

Uniquity Bio Appoints Will Kane as CEO to Lead Anti-TSLP Therapy Through Phase III Development

Monoclonal AntibodyLeadership Change
  • Uniquity Bio has appointed Will Kane as President and CEO to advance solrikitug, a monoclonal antibody targeting TSLP, through completion of three Phase II trials and preparation for Phase III development.
  • Kane brings over three decades of biopharmaceutical leadership experience from companies including Anthos Therapeutics, Karuna Therapeutics, and Pfizer, succeeding co-founder Brian Lortie who stepped down in June 2025.
  • Solrikitug is currently being evaluated in separate Phase II trials for asthma, chronic obstructive pulmonary disease, and eosinophilic esophagitis, with the company pursuing best-in-class efficacy and convenient dosing optimization.
  • The company is also developing bispecific candidates that combine solrikitug with other inflammatory targets to enhance efficacy and broaden patient populations across immunology and inflammation indications.

Singapore-Developed Cancer Drug PRL3-zumab Shows Promise for Treating Vision Loss in AMD and Diabetic Retinopathy

Monoclonal Antibody
  • A locally developed cancer drug PRL3-zumab will be tested intravenously in Singapore patients with wet age-related macular degeneration and diabetic retinopathy, offering a potential alternative to painful eye injections.
  • Pre-clinical studies published in Nature Communications showed the drug achieved 86% greater reduction in abnormal blood vessel leakage compared to current eye injection treatments.
  • The drug has demonstrated a good safety profile in 210 advanced cancer patients across Phase II trials in Singapore, the US, China, and Malaysia.
  • Singapore's Health Sciences Authority approved the human trial on June 16, with the 15-patient safety study expected to begin by late 2025.

Biogen and Acumen Advance Alzheimer's Research with Long-Term Data and Novel Targeting Approaches at AAIC 2025

Monoclonal Antibody
  • Biogen presents 48-month data from LEQEMBI's Clarity AD open-label extension study and introduces subcutaneous formulation for maintenance dosing at AAIC 2025.
  • The company shares baseline characteristics from CELIA Phase 2 trial evaluating BIIB080, an investigational antisense oligonucleotide therapy targeting tau protein.
  • Acumen Pharmaceuticals demonstrates cost savings from pTau217 screening in its ALTITUDE-AD Phase 2 trial and presents selectivity data for sabirnetug targeting toxic amyloid beta oligomers.

A Study to Learn About the Safety of BIIB080 Injections and Whether They Can Improve Symptoms of Participants With Mild Cognitive Impairment Due to Alzheimer's Disease (AD) or Mild AD Dementia Between 50 to 80 Years of Age

NCT05399888Active, Not RecruitingPhase 2
Biogen
Posted 8/24/2022

A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease

NCT03887455Active, Not RecruitingPhase 3
Eisai Inc.
Posted 3/27/2019

A Study to Evaluate Efficacy and Safety of Intravenous Sabirnetug in Participants With Early Alzheimer's Disease (ALTITUDE-AD)

NCT06335173Active, Not RecruitingPhase 2
Acumen Pharmaceuticals
Posted 2/29/2024

Anti-GPC3 Targeted Therapies Market Expands with Novel Treatment Approaches for Hepatocellular Carcinoma

CAR-TMonoclonal AntibodyTargeted Therapy
  • The anti-GPC3 targeted therapies market is expected to surge significantly by 2040, driven by increasing cancer incidence and clinical pipeline activity across hepatocellular carcinoma, non-small cell lung cancer, and gastric cancer.
  • AstraZeneca presented promising data from the RHEA-1 first-in-human study of AZD9793, a first-in-class CD8-guided T cell engager targeting GPC3-positive advanced or metastatic HCC at ASCO 2025.
  • Bayer initiated a Phase I clinical trial for 225Ac-GPC3 (BAY 3547926), an investigational targeted alpha radiopharmaceutical designed to treat GPC3-expressing tumors in patients with advanced HCC.
  • Key pipeline therapies include ECT204 from Eureka Therapeutics, currently under evaluation in the ARYA-3 Phase I/II trial for GPC3-positive HCC patients.

Ultragenyx's Setrusumab Phase 3 Trial Continues After Interim Analysis Fails to Meet Early Termination Threshold

Rare DiseaseMonoclonal Antibody
  • Ultragenyx Pharmaceutical's Phase 3 Orbit study of setrusumab for osteogenesis imperfecta failed to meet the interim statistical threshold for early termination (p<0.01), leading to a 27% stock decline on July 6.
  • The Data Monitoring Committee confirmed setrusumab's excellent safety profile and allowed trials to continue, with final readouts expected by year-end 2025 using more lenient statistical thresholds.
  • Phase 2 results previously demonstrated a 67% reduction in fractures (p=0.0014), supporting the drug's potential for treating the rare bone disease affecting approximately 60,000 patients globally.
  • Osteogenesis imperfecta currently has zero approved therapies, representing a significant unmet medical need with potential peak sales estimated at $1.6 billion by Goldman Sachs.

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