Israel-based RedHill Biopharma has reported positive Phase I trial final results of Yeliva (ABC294640) in patients with advanced solid tumours.
RedHill’s YELIVA is a Phase II, patented, orally administered product selectively inhibits the sphingosine kinase-2 (SK2).
It is characterised by anticancer and anti-inflammatory activities and targets multiple oncology, inflammatory and gastrointestinal indications.
The Phase I trial involved 21 patients with advanced solid tumours, with the majority being gastrointestinal cancer patients, including pancreatic, colorectal, cholangiocarcinoma cancers.
Patients were administered with the drug in cycles of 28 days and tumours were again scanned after every two cycles.
Results demonstrated the achievement the trial’s primary objective, which was to determine the maximum tolerated dose (MTD) for a safe administration of Yeliva to cancer patients in a circulating dosage cycle.
Patients displayed side-effects such as mild neuropsychiatric symptoms, which was mitigated by disontinuing the dosing.
The trial also met its secondary objectives, which focused on assessing the pharmacokinetic (PK) and pharmacodynamic (PD) properties of YELIVA and its anti-tumour activity.
RedHill medical director Terry Plasse said: "We are excited about the therapeutic potential of YELIVA for multiple oncology, inflammatory and gastrointestinal indications, and look forward to initiation of additional Phase II studies by the end of this year.
"Given Yeliva’s unique mechanism of action, we also strongly believe that it could provide an added benefit to cancer patients in combination with several of the leading oncology drugs currently available, and we are currently exploring potential collaboration opportunities to evaluate Yeliva as an add-on therapy."
The trial had included the first-ever longitudinal analyses of plasma S1P levels to pose as a potential pharmacodynamic biomarker to determine the activity of the drug.
The drug resulted to a rapid and a consistent decrease of S1P levels over the first 12 hours.
Yeliva hinders the synthesis of sphingosine 1-phosphate (S1P), which is lipid signalling molecule responsible for cancer growth and pathological inflammation.
The company is planning to conduct a Phase II trial to determine the efficacy of Yeliva to treat advanced hepatocellular carcinoma.