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Clinical Trial News

Assembly Biosciences' ABI-4334 Shows Potent Antiviral Activity in Phase 1b Chronic Hepatitis B Trial

  • Assembly Biosciences reported positive Phase 1b results for ABI-4334, a next-generation capsid assembly modulator, showing potent antiviral activity against chronic hepatitis B virus infection.
  • The 400 mg dose cohort demonstrated mean HBV DNA reductions of 3.2 log10 IU/mL over 28 days, consistent with the 150 mg cohort's 2.9 log10 IU/mL reduction.
  • ABI-4334 maintained a favorable safety profile with once-daily oral dosing supported by pharmacokinetic data across both dose levels.
  • The trial completion triggers Gilead Sciences' option to license ABI-4334 for further development under their existing collaboration agreement.

A Study to Assess the Safety, Tolerability and Pharmacokinetics of ABI-6250 in Healthy Participants

NCT06740474RecruitingPhase 1
Assembly Biosciences
Posted 1/31/2025

A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-4334 in Subjects With Chronic Hepatitis B Virus Infection

NCT06384131CompletedPhase 1
Assembly Biosciences
Posted 6/4/2024

MIRA Pharmaceuticals Unveils Preclinical Data for SKNY-1, Targeting Obesity and Smoking Cessation Without CNS Side Effects

  • MIRA Pharmaceuticals announced new in vitro preclinical data from Eurofins demonstrating SKNY-1's potential as a first-in-class oral therapy for obesity and nicotine addiction without central nervous system side effects.
  • SKNY-1 acts as a biased CB1 modulator, selectively blocking β-arrestin signaling associated with cravings while preserving G-protein signaling important for emotional stability.
  • The drug candidate also functions as a partial CB2 agonist and mildly inhibits MAO-B enzyme, targeting multiple pathways involved in appetite, addiction, and metabolic regulation.
  • The global obesity drug market is projected to surpass $150 billion by 2030, while the U.S. smoking cessation market is forecast to grow from $28 billion in 2024 to over $50 billion by decade's end.

Lupin Partners with Sino Universal Pharmaceuticals to Commercialize Tiotropium DPI for COPD Treatment in China

  • Lupin has signed a license and supply agreement with Sino Universal Pharmaceuticals for the commercialization of tiotropium dry powder inhaler (18 mcg/capsule) in China for chronic obstructive pulmonary disease treatment.
  • Under the partnership, SUP will obtain regulatory approvals for selling the product in China while Lupin serves as the marketing authorization holder and manufacturer.
  • The collaboration aims to address the increasing prevalence of respiratory conditions in China and expand patient access to innovative COPD treatments.
  • Tiotropium DPI is recognized for its efficacy in improving lung function and quality of life for patients with respiratory conditions.

Evaxion Launches AI-Powered Vaccine Program Against Group A Streptococcus

AI
  • Evaxion A/S has initiated development of EVX-B4, a new preventive vaccine targeting Group A Streptococcus (GAS), which causes hundreds of millions of infections globally each year.
  • The company's AI-Immunology™ platform successfully identified novel vaccine targets against GAS through initial computational analysis, potentially offering a new approach to combat this bacterial pathogen.
  • GAS infections range from mild conditions like strep throat to life-threatening diseases including necrotizing fasciitis and rheumatic heart disease, with no current preventive vaccine available.
  • The addition of EVX-B4 expands Evaxion's pipeline to eight vaccine candidates total, supporting the company's partnership strategy for out-licensing opportunities.

FDA Grants RMAT Designation to Detalimogene for High-Risk Bladder Cancer

  • The FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to detalimogene voraplasmid for treating high-risk BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ.
  • Preliminary data from the pivotal LEGEND trial showed a 71% overall complete response rate in 21 evaluable patients, with a favorable safety profile.
  • The RMAT designation provides regulatory advantages including expedited development, intensive FDA guidance, and potential for rolling or priority review.
  • Detalimogene is a non-viral gene-based immunotherapy designed for bladder instillation to elicit localized anti-tumor immune responses.

LEGEND Study: EG-70 in NMIBC Patients BCG-Unresponsive and High-Risk NMIBC Incompletely Treated With BCG or BCG-Naïve

NCT04752722RecruitingPhase 1
enGene, Inc.
Posted 4/22/2021

Angel Pharmaceuticals Receives China IND Approval for Soquelitinib Atopic Dermatitis Trial

  • Angel Pharmaceuticals received IND approval from China's NMPA to initiate a Phase 1b/2 clinical trial of soquelitinib for moderate-to-severe atopic dermatitis treatment.
  • The randomized, double-blinded, placebo-controlled trial will evaluate multiple dosing regimens over 12 weeks, with patient enrollment expected to begin in Q3 2025.
  • Soquelitinib is an investigational oral ITK inhibitor developed by Corvus Pharmaceuticals, representing a novel immunotherapy approach for immune diseases.
  • Phase 1b data is anticipated in 2026, while Corvus continues parallel development in the U.S. with plans for a Phase 2 trial by year-end.

Sanofi Advances Kymera's Next-Generation IRAK4 Degrader KT-485 to Clinical Testing

  • Sanofi has selected Kymera's KT-485, a next-generation oral IRAK4 degrader, to advance into Phase 1 clinical testing next year for immuno-inflammatory diseases.
  • KT-485 demonstrated superior preclinical performance compared to KT-474, showing increased selectivity and potency with a favorable safety profile.
  • The collaboration positions Kymera to receive up to $975 million in potential milestones, with the company already achieving a $20 million milestone in Q2 2025.
  • IRAK4 degradation represents a novel therapeutic approach that targets both kinase and scaffolding functions, potentially delivering broad anti-inflammatory effects in an oral drug format.

Gilead and Kymera Partner on Novel CDK2 Molecular Glue Degrader for Cancer Treatment

Oncology
  • Gilead Sciences and Kymera Therapeutics have entered into an exclusive option and license agreement to develop novel molecular glue degraders targeting CDK2 for cancer treatment.
  • The collaboration focuses on CDK2-directed molecular glue degraders that selectively remove the CDK2 protein from cells rather than just inhibiting its function, potentially offering more precise cancer treatments.
  • Kymera is eligible to receive up to $750 million in total payments, including up to $85 million in upfront and potential option exercise payments, plus tiered royalties on net product sales.
  • The oral CDK2 degraders have demonstrated compelling preclinical profiles and target breast cancer and other solid tumors with high unmet medical need.

Bio-Thera Solutions Initiates Phase 3 Trial for BAT8006 ADC in Platinum-Resistant Ovarian Cancer

Oncology
  • Bio-Thera Solutions has dosed the first patient in a pivotal phase 3 trial for BAT8006, an antibody-drug conjugate targeting folate receptor α for platinum-resistant ovarian cancer treatment.
  • Early clinical data from 133 patients showed BAT8006 achieved a median progression-free survival of 7.63 months with a 40.7% objective response rate and no cases of interstitial lung disease or ocular toxicity.
  • The therapy has potential to treat the full spectrum of platinum-resistant ovarian cancer patients regardless of folate receptor α expression levels, addressing a significant unmet medical need.
  • BAT8006 represents one of the first folate receptor α-targeting ADCs in China to enter pivotal phase 3 testing, potentially offering a novel therapeutic option for this difficult-to-treat patient population.

Hamlet BioPharma Receives FDA Clearance for Phase III Bladder Cancer Trial Following Successful Regulatory Meeting

Oncology
  • Hamlet BioPharma held its first in-person meeting with the FDA on June 24, 2025, receiving a clear pathway to Phase III trial initiation for Alpha1H in bladder cancer treatment.
  • The FDA provided positive feedback on the company's recently completed Phase II study data from December 2024, with the Alpha1H program being well-received by regulators.
  • The meeting resulted in helpful FDA guidance on Phase III trial design for non-muscle invasive bladder cancer (NMIBC) patients, which will support Alpha1H registration.
  • The company remains on track to initiate the Phase III trial following final protocol agreement and regulatory clearance, marking a key milestone toward market approval.

A First-in-Human Study of alpha1H in Patients With Non-muscle Invasive Bladder Cancer

NCT03560479Unknown StatusPhase 1
Hamlet Pharma AB
Posted 5/21/2018

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