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An aspect vital to a drug’s road to market are the clinical trials.

Clinical trials test the medicine in real patients under controlled conditions, assessing the efficacy and safety of the drug.

Across successive phases, clinical trials answer key questions like “Is the medicine effective for the target condition?”, "What side effects are experienced?”, “Does the medicine work consistently across different patient groups?” etc. This evidence is essential for regulatory approval and clinical use.

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For Tezspire, the EMA outlined 3 major clinical trials. They were called “Navigator”, “Pathway”, and “Source”.

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Navigator and Pathway tested how well Tezspire reduced asthma attacks. Source tested whether Tezspire could help patients reduce their use of oral corticosteroids when managing asthma.

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All 3 of these clinical trials used “placebo” drugs alongside Tezspire. There’s an issue in clinical trials called the placebo effect, so by using a placebo drug, it determines whether the treatment is effective beyond the psychological effect of simply receiving treatment.

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These clinical trials were also carried out in a “Double-Blind” format, which means both the participants and researchers are unaware who received the placebo drug or the real drug, minimising biases when patients report symptoms and recovery, and from researchers when recording the results.

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The Navigator study had 1,061 participants, and they were aged 12-80.

Pathway had 550 participants, aged 18-75.

Source had 150 participants, aged 18-80.

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• In total, over 1,700 people participated in the trials.

• A large sample size increases statistical power and reduces the likelihood that observed effects are due to chance alone.

• Additionally, the inclusion of participants aged 12–80 means that evaluations weren’t carried out in a homogenous group (i.e. only 40 year old men).

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As I said, the clinical trials Navigator and Pathway were assessing how well Tezspire could reduce asthma attacks.

In the 1^st study, patients given Tezspire had on average 0.93 asthma flareups per year after one year of treatment compared with 2.1 in patients given placebo.

In the 2^nd study, patients taking Tezspire had an average of 0.2 flareups after 1 year, compared with 0.72 in patients who received placebo. 

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In both studies, people taking Tezspire had far fewer asthma attacks than those on placebo. In one trial, attacks dropped by more than half; in the other, by almost three-quarters. With over 1600 patients combined alongside a large age range, the EMA approved this data.