Lupuzor™ Phase III Trials: Partnering With Immupharma
Lupuzor™ is an in-development treatment for Lupus, a chronic inflammatory disease thought to affect around 5 million people worldwide. Having recently undergone FDA approval, Lupuzor™ is commencing into phase 3 clinical trials.
Simbec-Orion are proud to have been selected by ImmuPharma as a partner to conduct the international phase 3 trial of Lupuzor™ involving pharmacokinetic study. Phase 3 research has been granted ethic committee approval, and volunteer selection and screening is set to be conducted in December 2021.
The Lupuzor™ phase 3 pharmacokinetic trial aims to deliver data by the end of 2022’s first quarter, with dosing of volunteers getting underway in January 2022. This builds upon the first pivotal phase 3 Lupuzor™ trial completed in 2018, which assessed the drug through open label extension study.
Progress from phase 1 and 2 Lupuzor™ trials has been promising. ImmuPharma have taken the opportunity to improve the drug’s product characterisation and analytical method validations. As a result, research has made developments with a new proprietary synthesis of P140, resulting in greater IP protection and lower production costs.
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Lupuzor™: Key Findings So Far
ImmuPharma have made significant advancements in developing a new treatment for Lupus. This drug, Lupuzor™ has shown potential as a treatment for Lupus during clinical research and has undergone significant testing across clinical trial phases.
Throughout clinical research stages, Lupuzor™ has shown strong efficacy in treating Lupus and has also demonstrated a strong safety profile. This provides promising results in the development of a new Lupus treatment, as the current standard treatment presents several side effects.
Phase 3 Lupuzor™ Trials
As part of phase 3 Lupuzor™ research, Simbec-Orion partnered with ImmuPharma to complete the initial phase 3 trial. As a CRO with expertise in Lupus research, our team ran the first Lupuzor™ phase 3 trial, which enrolled 62 patients to complete an open label extension study.
This initial Lupuzor™ phase 3 trial confirmed a successful safety profile for the drug, reporting no serious side effects or reactions. These insights enabled our trial management team to commence with an optimal phase 3 trial design together with ImmuPharma.
The next stage of phase 3 Lupuzor™ research will involve a pharmacokinetic study, helping further evaluate the drug’s safety profile and efficacy.
Why Lupus Research is Important
Affecting an estimated 5 million people worldwide, Lupus is a chronic inflammatory, autoimmune disease that can be life threatening. Lupus can impact various parts of the body, including skin, kidneys, the brain, heart and lungs.
Diagnosis can be challenging, since Lupus can appear in several different forms and although awareness is steadily increasing, it does not have the greatest level of recognition.
As well as challenges in diagnosis, the current standard treatment for Lupus can often present adverse side effects. As well, the standard treatment has limited efficacy. As a result, there is an unmet need for an effective Lupus treatment with stronger efficacy and fewer side effects.
Partner With Simbec-Orion
Partnerships are an effective way to balance the costs of drug development, alongside other strategies such as using a decentralised virtual laboratory. Experts in clinical trial management, we’re here to support you with your clinical development needs. Get in touch with our expert team to find out more.