Table 5.
Summary of the relative potency ranges and potency ratios of capsule and sachet lots used in ARC003 and ARC010 clinical studies.
| Clinical Study | Number of Drug Product Batches | Ara h 1 |
Ara h 2 |
Ara h 6 |
|||
|---|---|---|---|---|---|---|---|
| Potency Rangea | Ratiob | Potency Rangea | Ratiob | Potency Rangea | Ratiob | ||
| PALISADEc (ARC003) | 8 | 0.68–1.59 | 2.34 | 0.72–1.34 | 1.86 | 0.63–1.26 | 2.00 |
| ARTEMISd (ARC010) | 11 | 0.68–1.25 | 1.83 | 0.93–1.34 | 1.44 | 0.75–1.26 | 1.68 |
| Total | 19 | 0.68–1.59 | 2.34 | 0.72–1.34 | 1.86 | 0.63–1.26 | 2.00 |
The data shown in the table are from a total of 5,246 individual up-dosing events for 520 patients.
Relative to the reference standard.
Ratio is from highest to lowest potency.
PALISADE: Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization (22).
ARTEMIS: AR101 Trial in Europe Measuring Oral Immunotherapy Success (23).