Sorrento Therapeutics Announces Positive Phase 2a Clinical Trial Results for Resiniferatoxin (RTX) for the Treatment of Knee Pain in Moderate to Severe Osteoarthritis of the Knee (OAK) Patients

• All study objectives were met, demonstrating safety across dose groups and confirming efficacy and durability at the selected doses against placebo (lidocaine) and active control (steroid).
• All RTX doses (7.5 to 20 µg) were well-tolerated, with few severe or serious adverse events (AEs). The majority of reported AEs related to pain post-administration and resolved within hours following treatment. Very few severe AEs were reported across groups (including placebo) with no dose correlation. RTX post-injection administration pain was easily controlled.
• RTX 20mcg dose outperformed all other dose groups (including the approved drug for this indication (intra-articular corticosteroids)) for efficacy and durability at and beyond 26 weeks post-treatment. RTX 20mcg and 12.5mcg have been selected as the clinically optimal and minimally effective doses for further phase 2 pivotal or phase 3 trials.
  

SAN DIEGO, Sept. 07, 2023 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (OTC: SRNEQ, "Sorrento") announced today positive Phase 2a top-line clinical trial results for the RTX program.

The Phase 2a study follows the positive observations from the Phase 1b/2 trial results (NCT03542838) of RTX Day 84 patient data, for which Sorrento has completed the one-year follow up for the last patient dosed in February 2021.

The phase 2 trial, a multi-center, double blind, placebo- and active-controlled study, assessed the efficacy and safety of several dose groups of RTX to manage pain in patients with moderate-to-severe OAK (clinicaltrials.gov: NCT04885972). Given the durability of OAK pain relief response to RTX demonstrated in earlier phase 1b/2 trials, Sorrento decided to include an active approved comparator (Zilretta intra-articular corticosteroids) in the current trial protocol.

Top-Line Safety Outcomes (Summary)

Generally, treatment was well-tolerated, with the most common noted AE being pain following topical capsaicin 0.1% given to all patients for blinding purposes and study drug administration in the knee (across all dose groups).

Very few serious AEs were noted across all dose groups, with one in particular (see below for additional detail) in the 15mcg RTX group being severe/life threatening (hypertension following drug administration), which resolved within hours with treatment of pain and no additional intervention.

In the cases requiring pain control (any group) the dose of opioid was comparable. A few subjects in RTX groups required use of low dose oral opioids for up to 6 hours in some cases of prolonged moderate discomfort/pain. No patient required additional pain control or intervention after 6 hours or in the days following the day of administration and no patient left the clinic with opioids or an opioid prescription.