Clinical Development (Phase I-IV)
The NIMML Institute has developed a fully integrated clinical research service focused around, participant recruitment, efficacy and tolerability measurements, including product safety evaluation and appropriate regulatory controls. Clinical research is one of our core activities. As an impact and result-driven organization we target advancing therapeutic assets into clinical trials at an accelerated rate to allow advancement of potentially impactful therapeutic assets from bench to clinic and market. At NIMML, we thrive at shortlisting and selecting the most promising assets to clinical trials that can bring treatment options to patients as quickly as possible.
The NIMML human clinical studies are reviewed by the appropriate central or local Institutional Review Board (IRB). The NIMML Institute is ready to partner and provide our bioinformation systems and modeling and simulation experience to define the best experimental design for optimal clinical results.
The NIMML has extensive capabilities and established clinical partnerships for clinical studies aimed at testing the efficacy of novel immune modulatory compounds that target infectious, metabolic and autoimmune diseases.
Specific clinical capabilities include:
- Modeling and simulation for optimal clinical trial design
- Investigational New Drug (IND) regulatory aspects
- Patient recruitment
- Validated immunological assay development
- Bioinformatics services
- Biomarker discovery
- Bioanalytical services
Each clinical trial has its own unique set of approaches regardless of the various therapeutic modalities and requires strategic planning (scientific, clinical, operations, and regulatory) and implementation of all critical steps to yield the best results possible for the patients and allow additional options to choose from, for the physicians. The strategic planning of our clinical trials offers an efficient, broad, flexible hypotheses-testing allowing for implementation of streamlined logistical infrastructure along with innovative, statistical approaches to improve interactions between patients and physicians and participation of patients to generate meaningful data to get regulatory approvals for products to market.
Our in-house team of scientists, clinical, operations and regulatory experts work closely together and with external collaborators to support robust clinical trials. Please see below list of collaborations and clinical trials conducted by our team in the recent past:
|Collaborator||Study Phase||Study Indication||Protocol ID and Study Full Name (protocol name)||Clinical Trial Registration Number (CTR Number)|
|Landos Biopharma Inc.||Phase 2||UC||BT-11-201 - Efficacy and Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis||NCT03861143|
|Landos Biopharma Inc.||Phase 2||CD||BT-11-202 - Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn’s Disease||NCT03870334|
|Landos Biopharma Inc.||Phase 1||UC||NX-13-1a - Safety, Tolerability and Pharmacokinetics of Oral NX-13 in Healthy Adults Male and Female Volunteers||NCT04458805|
|Landos Biopharma Inc.||Phase 1||UC||BT-11-1a - Safety, Tolerability, and Pharmacokinetics of Oral BT-11 in Healthy Adult Male and Female Volunteers||NCT04458805|