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Polpharma Biologics S.A.

Address: Ul. Trzy Lipy 3

Sponsor Overview

assignment

Specializations

Inflammatory Bowel Disease

Research activity includes ulcerative colitis, with a focus on treatments for moderately to severely active disease and the evaluation of gastrointestinal inflammation in clinical settings.

Ulcerative colitis
Inflammatory bowel disease
Clinical response

The sponsor’s trial portfolio reflects interest in therapies used to manage persistent bowel inflammation and related symptom control.

Biologic Therapy Evaluation

Clinical research covers the assessment of biologic medicines in comparison with an established reference treatment, with attention to therapeutic equivalence in immune-mediated disease.

Biologic comparability
Therapeutic similarity
Immune-mediated disorders

This area includes study interest in integrin-targeted therapy and other advanced treatments for chronic inflammatory conditions.

Pharmacokinetics and Immunogenicity

Trials also examine pharmacokinetics, immunogenicity, and safety in healthy participants to characterise how the investigational product behaves after administration.

Healthy volunteers
Systemic exposure
Anti-drug immune response

These studies support interest in the biological profile of subcutaneous administration and treatment tolerability.

Gastroenterology Clinical Development

The sponsor’s research landscape is centred on gastroenterology, with active trials across multiple countries and sites supporting evaluation of new treatment options for intestinal disease.

Digestive system disorders
Multinational clinical research
Treatment safety

Work in this area connects clinical efficacy assessment with the development of therapies intended for chronic immune-related intestinal disease.

Trial Name	Country	Status
A randomized, double-blind, multicenter phase 3 study in patients with moderately to severely active ulcerative colitis (UC) to compare the efficacy, safety and immunogenicity of PB016 and Entyvio® for the induction and maintenance of clinical response and remission. (UCESIVE)	Bulgaria Czechia Hungary Latvia Poland Romania Slovakia	Not Recruiting
Pharmacokinetics, Immunogenicity, and Safety Comparison of PB016 and US-Licensed Vedolizumab in Healthy Volunteers After Subcutaneous Administration	Germany	Not Recruiting