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Clinical Trial News

Anthem Biosciences Launches ₹3,395 Crore IPO as Contract Research Organization Targets Public Markets

  • Anthem Biosciences, a Contract Research, Development, and Manufacturing Organization (CRDMO), is launching a ₹3,395 crore IPO from July 14-16 with shares priced at ₹540-570 each.
  • The company reported strong financial performance with revenue growing 30% year-on-year to ₹1,844 crore in FY25 and profit after tax increasing 23% to ₹451 crore.
  • The IPO is entirely an offer for sale by existing shareholders, meaning no proceeds will go to the company for expansion or operations.
  • Anthem operates integrated pharmaceutical services from drug discovery to manufacturing, specializing in complex fermentation-based APIs including probiotics, enzymes, and biosimilars.

Simcere Submits New Drug Application for Rademikibart in China's 70 Million Patient Atopic Dermatitis Market

Monoclonal Antibody
  • Simcere Pharmaceutical has submitted a New Drug Application to China's NMPA for rademikibart, targeting atopic dermatitis treatment in adults and adolescents.
  • The IL-4Rα-targeting monoclonal antibody addresses China's substantial atopic dermatitis market, estimated at 70 million patients.
  • Connect Biopharma stands to receive up to $110 million in milestone payments and tiered royalties from the exclusive licensing agreement established in 2023.

Sarilumab Combination Achieves 63.6% Response Rate in Advanced Melanoma Phase 2 Trial

  • A phase 2 study demonstrated that adding sarilumab to ipilimumab, nivolumab, and relatlimab achieved a 63.6% overall response rate in patients with unresectable stage III or IV melanoma.
  • The combination showed one of the highest response rates observed in melanoma checkpoint inhibitor studies to date, with a 78.8% clinical benefit rate at 24 weeks.
  • Grade 3/4 immune-related adverse events occurred in only 12.1% of patients, significantly lower than comparable studies using anti-CTLA-4 regimens.
  • The IL-6 receptor blocking approach appears to enhance efficacy while reducing toxicity compared to existing checkpoint inhibitor combinations.

Interleukin-6 Receptor Inhibitor Sarilumab in Combination With Ipilimumab, Nivolumab and Relatlimab in Patients With Unresectable Stage III or Stage IV Melanoma

NCT05428007RecruitingPhase 2
NYU Langone Health
Posted 12/16/2022

Johnson & Johnson Submits FDA Application for CAPLYTA Schizophrenia Relapse Prevention Based on 63% Risk Reduction Data

Drug Approval
  • Johnson & Johnson submitted a supplemental New Drug Application to the FDA for CAPLYTA (lumateperone) for schizophrenia relapse prevention based on Phase 3 data showing 63% reduction in relapse risk versus placebo.
  • The multicenter, double-blind trial demonstrated significantly longer time to relapse during 26-week treatment phase (p=0.0002) and delayed time to all-cause discontinuation (p=0.0007).
  • CAPLYTA is already FDA-approved for schizophrenia treatment and bipolar depression, with this expansion potentially addressing a critical unmet need in long-term schizophrenia management.
  • The safety profile remained consistent with existing clinical data, with headache being the most commonly reported adverse event at rates exceeding placebo.

FDA Authorizes Emergency Compassionate Use of VAR 200 for Ultra-Rare ApoCII Amyloidosis

Rare DiseasePrecision MedicineOrphan Drug
  • The FDA has authorized emergency compassionate use of ZyVersa Therapeutics' VAR 200 for a patient with ApoCII amyloidosis, an ultra-rare kidney disease with no effective treatment options.
  • VAR 200, currently in Phase 2a trials for diabetic kidney disease, targets lipid accumulation in kidneys and was selected based on evidence of lipotoxic glomerular injury in the patient's kidney biopsy.
  • The treatment will be administered at the University of Miami under Dr. Alessia Fornoni's care, following the protocol of the ongoing diabetic kidney disease clinical trial.
  • This compassionate use case represents a precision medicine approach to match patients with specific molecular signatures to targeted therapies for rare diseases.

P2a Open Label Study to Evaluate 2-HPβCD in Subjects With Diabetic Kidney Disease

NCT06489340RecruitingPhase 2
ZyVersa Therapeutics, Inc.
Posted 6/11/2025

Crescent Biopharma Appoints Jan Pinkas as Chief Scientific Officer to Advance Oncology Pipeline

Oncology
  • Crescent Biopharma has appointed Jan Pinkas, Ph.D., as chief scientific officer, bringing over two decades of oncology drug development experience including expertise in antibody-drug conjugates.
  • The company expects to begin dosing patients in a global Phase 1 trial of CR-001, a PD-1 x VEGF bispecific antibody, in early 2026.
  • Crescent anticipates submitting an IND application for CR-002, a novel antibody-drug conjugate, in mid-2026.
  • Dr. Pinkas previously served as chief scientific officer at Pyxis Oncology and contributed to the development of ELAHERE, an approved ADC for platinum-resistant ovarian cancer.

Optibrium Secures Multi-Million Pound Financing to Accelerate AI-Powered Drug Discovery Platform

AIDrug Discovery
  • Optibrium, a leading developer of AI solutions for molecular design, secured a strategic multi-million-pound financing package from Shawbrook to accelerate drug discovery technology development.
  • The funding will enhance Optibrium's generative chemistry, collaborative design, and 3D molecular modeling capabilities while supporting global expansion of its computational chemistry platform.
  • Over 160 global pharmaceutical and biotech organizations currently use Optibrium's software suite for compound design and optimization, contributing to faster and more efficient drug discovery timelines.
  • The computer-aided drug discovery market is projected to grow from $4.21 billion in 2024 to $13.08 billion by 2034 at a 12% compound annual growth rate.

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.

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

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

NCT05099770RecruitingPhase 3
Prokidney
Posted 1/5/2022

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.

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