said its licensing partner, Avion Pharmaceuticals, has submitted a Special Protocol Assessment ("SPA") request to the US Food & Drug Administration (“FDA”) for Lupuzor™, a novel peptide therapeutic for the treatment of systemic lupus erythematosus.
The specialist drug discovery and development firm said the SPA is an important regulatory milestone in preparation for the new optimised international Phase III trial of Lupuzor™.
As part of the SPA, sponsors will reach an agreement with the FDA on the design and size of clinical trials, addressing all requirements for a study that could support marketing approval.
The previous Phase III clinical trial of Lupuzor™ in systemic lupus erythematosus was also carried out under ImmuPharma's SPA. The review period for a request is up to 45 days.
ImmuPharma and Avion have worked closely on the clinical trial design and strategy since they signed an agreement in November 2019 for Lupuzor™, with Avion agreeing to fund a new international Phase III trial and commercialise the treatment in the US.
Shares in ImmuPharma have been trending upwards over the past three months from 12.5p to closed at 15.03p on Friday afternoon.
This tripartite Phase III protocol development approach ‘provided thorough and detailed support for developing the most relevant clinical trial for Lupuzor™ in patients with lupus.’
Results from the first Phase III clinical study were analysed and a new optimised international Phase III study protocol was finalised and is now the subject of the SPA request to the FDA.
The new Phase III study design will be communicated to the market at a later date, once agreed with the FDA, the company added.
In May 2020, ImmuPharma said a study conducted at Emory University Atlanta in the US suggested that its Lupuzor™ treatment could potentially reduce symptoms of coronavirus.
As a result of the findings, the company said that further exploratory work is now underway to assess Lupuzor's possible potential and clinical program in Covid-19 patients.
At the time, the group said its technology could “help bring together a therapy that could be effective against the inflammation that causes the serious complications of Covid-19.”
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