Resource Type: Clinical Trial Publications

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).

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.

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.

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.

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.

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.

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.

 KalVista Pharmaceuticals partnered with Simbec-Orion to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of KVD900, an orally administered inhibitor of PKa in healthy adults.

An extra fine formulation triple therapy combination of beclomethasone dipropionate (BDP), formoterol fumarate (FF), and glycopyrronium bromide (GB) has been developed for the maintenance treatment of asthma and chronic obstructive pulmonary disease. This study used gamma scintigraphy to evaluate the intrapulmonary and extrapulmonary in vivo deposition of BDP/FF/GB, and the intrapulmonary regional distribution of the deposited formulation

Several inflammatory cytokines that promote inflammation and pathogenesis in asthma signal through the Janus kinase 1 (JAK1) pathway. This phase I, randomized, placebo-controlled trial assessed the pharmacokinetics and safety of single and multiple ascending doses up to 15 mg twice daily for 14 days of a JAK1 inhibitor, GDC-0214, in healthy volunteers (HVs; n = 66).