Imm17 Nov 2018 20:59
Far from giving up on Lupuzor™, ImmuPharma immediately began working on ways to continue the drug’s progression following April’s news. Under the request of investigators and patients, it is carrying out a six-month follow-up study, permitting patients from the completed phase III study to continue receiving the drug. These results are due in Q2 2019. Meanwhile, in May, it released additional analysis of the Phase III trial that found a statistically significant reduction in disease activity among the European cohort group, who were antibody positive.
Finally, in September, the firm announced that it had signed an agreement with a specialist provider to distribute Lupuzor™ in what is known as a Managed Access Programme (MAP). The MAP, which ImmuPharma will fund from its existing cash resources, will give up to 500 patients early access to the medication for a minimum of two years, before any regulatory filings.
The programme is longer, more extensive and cheaper than the Phase III trial, which cost c. €10m and was carried out on 200 patients for twelve months. It also gives ImmuPharma access to ongoing results rather than having to wait until the programme has completed.
McCarthy tells us this ‘real-time’ approach allows ImmuPharma to monitor the drug’s effectiveness as the trial unfolds, which, from an investor’s standpoint, means it can deliver regular newsflow throughout the process. He adds that the data generated from the MAP will also be an invaluable addition to the firm’s application for final regulatory approval:
‘Not only will the MAP allow us to help patients ahead of our drug being approved, it will provide us an invaluable set of data that we can put into the application for when we do go for formal approval, at some point in the future. These programmes are becoming increasingly common. Out of the top 20 pharma companies globally, 18 are using MAP on a regular basis to supplement clinical trial data.’
Although he is optimistic that the MAP can support Lupuzor™’s progression, McCarthy says it is not yet clear whether the programme will be enough to cement FDA approval. Traditionally, the regulator must receive two separate Phase III studies with similar results before awarding a marketing license for a drug. However, McCarthy says the regulatory world is changing, adding that the firm’s application could benefit from an ongoing debate between the FDA and industry experts over a lack of approved lupus drugs:
‘The representative body for lupus patients has argued that the FDA should alter the design of trials for drugs because they are currently struggling to find success. If the FDA re-designed the trials to account for the current anomalies then there would likely be a much higher success rate. These discussions are ongoing, and we remain in contact with our regulatory advisers around the FDA’s attitude to the use of MAP data as a supplement to clinical development data in licence applications.’
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