Company: SMNR
Filing Date: 2025-04-21
Form Type: S-4/A
Source: 0001193125-25-087342
Chunk: 484

Company: Semnur Pharmaceuticals, Inc.
Filing Date: 2025-04-21
Form: S-4/A
Chunk 484
---
 SP-102 showed continued pain reduction with no unexpected adverse events based on preliminary results from the SP-102-03 study; and |

| • |     | SP-102 showed an extended local activity with epidural administration in the ES-1504 study. |

294

Study Details Phase 3 Pivotal Clinical Trial — CLEAR We have completed a pivotal, randomized, double-blind, placebo-controlled Phase 3 trial, CLEAR, that enrolled 401 patients with sciatica at over 40 sites across the United States. The study included an open-label extension where subjects were followed for up to 24 weeks after treatment to evaluate the tolerability of administering SP-102in a larger patient population. After week four, subjects who met certain pain criteria received open-label SP-102to investigate the tolerability of repeat injections and the duration of pain relief following injection. This well-controlled, double-blind, randomized trial was designed to demonstrate evidence of the analgesic effect and tolerability of SP-102.The schematic of this Phase 3 trial is demonstrated in the flowchart below. The primary objective of this study was to evaluate the analgesic effect of SP-102on average leg pain, measured using the NPRS following a single transforaminal injection. These results were compared to an intra-muscular injection of placebo over a four-week period. The secondary objectives of this study include (i) evaluation of the degree of disability over time as measured by the ODI; (ii) characterization of the change of the subject’s radiculopathy symptoms and overall condition, using a combination of PainDETECT, modified Brief Pain Inventory, Clinical Global Impression of Change (“CGIC”), and Patient Global Impression of Change (“PGIC”) and (iii) evaluation of the tolerability of a single and repeat SP-102injection. Schematic of CLEAR - SP-102 (SEMDEXA) Phase 3 Pivotal Trial Results of CLEAR - SP-102Phase 3 Pivotal Trial A full six-monthdata analysis was completed in February 2022, and we announced final results from the study in March 2022, which results reflect achievement of primary and secondary endpoints. The Phase 3 study results have been published in PAIN ®Journal (Miller et al 2024) and we also presented the pivotal Phase 3 trial results at the American Society of Interventional Pain Physicians annual meeting in Las Vegas, Nevada in May 2022. The Phase 3 CLEAR trial summary results, which results reflect achievement of