Simulation in clinical research- what does the future hold for us 2InSilicoTrials is bringing several projects together and is aiming to encourage the use of simulation in the development of drugs and medical devices.

‘In silico’ is understood as an experiment performed on a computer or via a simulation. EU’s Horizon 2020 programme coordinated by the University of Bologna: „In Silico World” will develop 11 solutions for Italian start-up InSilicoTrials.

InSilicoTrials leverages computational technologies to test the safety and efficacy of medical devices and products, including advanced solutions such as tissue engineering constructs for regenerative medicine. The company says modelling and simulation can reduce clinical trial-associated costs by up to 50% and greatly accelerate the go-to-market of new products.

The solutions developed as part of the In Silico World project will target medical products to treat osteoporosis, tuberculosis, multiple sclerosis, coronary stenosis, cerebral aneurysms, mammary carcinoma and Covid-19 infection, among others.

As these solutions are developed, the consortium will produce data for validation, regulatory pathways and technical standards. It will also produce policy documents and information packages for patients, doctors and senior healthcare industry stakeholders, as well as computational strategies to make such simulations more powerful and efficient.

The consortium will also focus on developing new curricula to educate the workforce on the development and use of InSilicoTrials’ technologies, and a robust business model for the commercial exploitation of these technologies.

In a statement, In Silico World co-ordinator and University of Bologna professor Marco Viceconti said: “The aim of the In Silico World project is to accelerate the uptake of modelling and simulation technologies for the development and regulatory assessment of medicines and medical devices, with a long-term impact of reduction of the cost and duration of the development and regulatory assessment of new medical products, while maintaining or improving the level of safety provided by conventional approaches.”

Simulation in clinical research- what does the future hold for us 3Galapagos and Gilead Sciences have announced the decision to discontinue the ISABELA Phase III clinical studies of ziritaxestat (GLPG1690) in patients with idiopathic pulmonary fibrosis (IPF).

Discovered by Galapagos, ziritaxestat is an investigational autotaxin inhibitor. In July 2019, Gilead in-licensed ex-European rights to ziritaxestat and began sharing the Phase III development costs.

The latest move is based on the recommendation by the Independent Data Monitoring Committee (IDMC). Following a regular review of unblinded data, the committee noted that ziritaxestat’s benefit-risk profile no longer supported the continuation of these studies.

Galapagos chief medical officer Dr Walid Abi-Saab said: “We are very disappointed not to be able to bring a novel medication to patients suffering from such a devastating disease with high unmet need.

“We intend to learn from this data in our continued commitment to developing therapies in IPF and fibrosis.”

Investigators are being notified of the discontinuation of the studies and the participants will be informed to stop the investigational treatment.

The ISABELA Phase III programme has two trials that have been identically designed: ISABELA 1 & 2, intending to enrol a total of 1,500 IPF patients.

Patients continued on their standard of care background treatment and randomly received either a once-daily dose of ziritaxestat 200mg or 600mg or placebo.

Simulation in clinical research- what does the future hold for us 4The Janssen Pharmaceutical Companies of Johnson & Johnson has reported that the Phase III ACIS study of Erleada and Zytiga combination in patients with metastatic castration-resistant prostate cancer (mCRPC) met the primary endpoint.

The study met the endpoint of radiographic progression-free survival (rPFS) in patients with chemotherapy-naïve mCRPC receiving androgen deprivation therapy (ADT).

Erleada is an AR inhibitor, while Zytiga (abiraterone acetate) in combination with prednisone is indicated for treating patients with mCRPC.

The randomised, double-blind, placebo-controlled, multi-centre clinical study analysed the efficacy and safety of Erleada and Zytiga plus prednisone versus placebo and Zytiga plus prednisone in 982 patients with chemotherapy-naïve mCRPC disease who received ADT.

In the trial, the subjects randomly received either Erleada and Zytiga plus prednisone (combination arm), or placebo and Zytiga plus prednisone (control arm).

The study’s primary endpoint was rPFS while secondary endpoints included Overall Survival (OS), time to chronic opioid use, time to initiation of cytotoxic chemotherapy and time to pain progression.

The primary efficacy analysis showed median rPFS was increased by six months in patients in the combination arm versus control arm.

An updated analysis conducted at a median follow-up of 54.8 months showed a 30% reduction in the risk of radiographic progression or death in the combination arm versus the control.

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