Clinical Trial Publications

Simbec-Orion have worked on countless clinical trials and in many different roles thanks to our wide range of CRO services including clinical development, central laboratory services and pharmacovigilance. These publications detail the process and results of a range of clinical research projects in which we’ve been a co-sponsor or the research site.

For more information on each study, please click through to view the paper.

2021 Publications

Phase I/II trial of Bexmarilimab in solid tumours

Full title: Bexmarilimab, a novel macrophage re-programmer shows promising anti-tumour activity in phase I/II trial in several last line solid tumour types

Publication Date: September 2021

About this study: Simbec-Orion worked with Faron Pharmaceuticals LTD on this three-part, first-in-human phase I/II study. It was designed to assess the safety and efficacy of Bexmarilimab in Oncology patients with advanced solid tumours. The study showed that good safety and tolerability of Bexmarilimab in this initial stage, and highlighted potential for anti-tumour activity as a monotherapy.

Please view: http://shorturl.at/hBQ47

KVD900 Phase 2 Oral On-Demand Treatment for HAE Attacks

Full title: KalVista Pharmaceuticals Reports Positive Results for KVD900 Phase 2 Demonstrating Statistically and Clinically Significant Responses Across All Endpoints as an Oral On-Demand Treatment for HAE Attacks

Publication Date: February 9th 2021

About this study: We worked with KalVista Pharmaceuticals to study Oral KVD900 in Patients with Hereditary Angioedema (HAE) in this phase II clinical trial. Results included the observation that attacks treated with KVD900 significantly reduced use of rescue with 15% of KVD900 treated attacks rescued compared to 30% on placebo at 12 hours.

Please view: https://www.businesswire.com/news/home/20210209005388/en/

2020 Publications

Phase I/II trial of Clever-1 blockade in advanced cancer

Full title: A phase I/II MATINS trial: Part 1 pharmacokinetic, safety and efficacy results of Clever-1 blockade in advanced cancer

Publication Date: September 2020

About this study: CLEVER-1 is a scavenger receptor expressed in tumour associated macrophages. We worked with Faron Pharmaceuticals on this trial, designed to assess the safety and preliminary efficacy of FP-1305 in patients with advanced solid tumours. It showed that the compound promotes immune switch and peripheral lymphocyte activation and has promising tolerability.

Please view: http://shorturl.at/izOVY

Immune activation in first-in-human anti-macrophage antibody

Full title: Immune activation in first-in-human anti-macrophage antibody (anti-Clever-1 mAb; FP-1305) phase I/II MATINS trial: Part I dose-escalation, safety, and efficacy results.

Publication Date: 20th May 2020

About this study: We worked with Faron Pharmaceuticals on this trial, a multicentre first-in-human phase I/II study. It assessed the tolerability, safety and preliminary efficacy of FP-1305 in patients with advanced cancers including immunotherapy-refractory melanoma, cholangiocarcinoma, hepatocellular carcinoma, ovarian cancer, colorectal (CRC), and pancreatic ductal adenocarcinoma.

Please view: http://shorturl.at/moxMN

Impact of ACT‐539313 on the Pharmacokinetics of Midazolam

Full title: Impact of the Selective Orexin‐1 Receptor Antagonist ACT‐539313 on the Pharmacokinetics of the CYP3A Probe Drug Midazolam in Healthy Male Subjects

Publication Date: February 9th 2020

About this study: Simbec-Orion worked with X on this single‐center, open‐label, fixed‐sequence study. It examined the effect of ACT‐539313 on the pharmacokinetics of orally administered midazolam to investigate the interaction potential.

Please view: https://pubmed.ncbi.nlm.nih.gov/32035014/

2019 Publications

Immune activation with a novel immune switch anti-macrophage antibody

Full title: Immune activation with a novel immune switch anti-macrophage antibody (anti-Clever-1 mAb; FP-1305) in phase I/II first-in-human MATINS trial in patients with advanced solid tumours

Publication Date: October 1st 2019

About this study: Simbec-Orion worked with Faron Pharmaceuticals Ltd. in this phase I/II first-in-human in patients with advanced solid tumours, studying the effect of FP-1305. Analysis of circulating immune cells after administration of the compound demonstrates Th1 activation as well as mobilization of NK cells and B cells. It showed promising tolerability and clinical anti-tumour activity.

Please view: http://shorturl.at/ghqsH

Comparative Bioavailability Study of a new Orodispersible Formulation of Ibuprofen

Full title: Comparative Bioavailability Study of a New Orodispersible Formulation of Ibuprofen Versus Two Existing Oral Tablet Formulations in Healthy Male and female Volunteers

Publication Date: Aug 2019

About this study: Simbec-Orion worked with Reckitt Benckiser Health Limited on this study. It analysed the comparative bioavailability between ibuprofen acid orodispersible tablets and ibuprofen acid oral tablets.

Please view: https://pubmed.ncbi.nlm.nih.gov/31202508/

Bioequivance of 2 Naproxen Sodium Tablet Formulations

Full title: Bioequivalence of 2 Naproxen Sodium Tablet Formulations in Healthy Male and Female Volunteers

Publication Date: Jan 18th 2019

About this study: Simbec-Orion worked with Reckitt Benckiser Health Limited. This study looke at Reckitt Beckiser Healths' naproxen sodium tablet's comparative bioavailability against a reference medicinal product, Aleve naproxen sodium (220 mg).

Please view: https://pubmed.ncbi.nlm.nih.gov/30828406/