Company: SMNR
Filing Date: 2025-06-11
Form Type: S-4/A
Source: 0001193125-25-139124
Chunk: 498

Company: Semnur Pharmaceuticals, Inc.
Filing Date: 2025-06-11
Form: S-4/A
Chunk 498
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 baseline averaged daily pain score as factors were used to compare the treatment groups at each week. |

**CI: confidence interval; ITT: intent-to-treat(randomized population) Phase 2 Repeat Dose Study — SP-102-03 We conducted an open-label, single-arm,pharmacodynamics (“PD”) and tolerability study of repeat epidural injections of SP-102in patients with sciatica. We conducted this study to characterize repeat dose PD with respect to hypothalamic-pituitary-adrenal suppression using plasma cortisol levels, white blood cell count and blood glucose levels. The study enrolled 19 subjects, of which 15 received repeat SP-102epidural injections four to eight weeks after the initial injection. Four of the subjects did not experience recurrent pain and thus did not require a repeat injection. The daily average, current and worst pain in the affected leg and back showed continuous reduction throughout the 28-dayobservation period for both treatments. Based on a preliminary review of the results, SP-102injections were generally well tolerated and there were no new unexpected adverse events observed. Mean Percentage Change in Sciatica-Related Leg Pain as Measured by NPRS Phase 1 Trial of SP-102Compared to RLD—ES-1504 We conducted an open-label, single-arm, two-period,fixed sequential-dose study to evaluate the PK, PD and tolerability of SP-102when administered by epidural injection. SP-102was compared to intravenous dexamethasone sodium phosphate injection in subjects with lumbosacral radiculopathy. There were 12 subjects enrolled in this study, all of whom received SP-102followed by the intravenous dexamethasone sodium phosphate injection (RLD) administered one month later. A RLD is an approved drug product to which new versions are compared to show that they are bioequivalent. The purpose of this study was to establish the pharmaceutical bridge between SP-102and the RLD. The time to maximum serum concentration (“Tmax”) observed with the administration of SP-102was four hours, compared to 15 minutes observed with intravenous dexamethasone. The PD parameters and tolerability profiles of both products were similar, and SP-102did not prolong cortisol suppression time. SP-102also maintained analgesic effects throughout a one-monthobservation period. The overall systemic exposure of dexamethasone was similar, whether administered as SP-102or injected intravenously, with a mean AUC