RTX-OAK-201: Clinical Trial for Knee Pain Due to Osteoarthritis

Investigational Product

Resiniferatoxin (RTX) is a small-molecule derivative (diterpene ester), purified from a cactus-like plant source. It is a highly potent agonist of the transient receptor potential vanilloid-1 (TRPV1) receptor and is obtained from the latex of several Euphoria species, such as E. resinifera or E. poisonii.

Inclusion Criteria

● Adult ≥ 18 years of age with a BMI < 50 kg/m● Moderate to severe pain in the index knee due to OA (≥ 6 months prior to Screening)● Worst daily average pain of ≥ 4 (0-10 NRS) during the week prior to Screening● Knee x-ray or MRI scan with KL grade ≥ 2 (within 3 months prior to Screening)● Treatment failure/inadequate response with at least 2 prior analgesic agents (at least 1 NSAID)● Willing to abstain from other IA injections/ knee surgery for at least 6 months after study treatment, unless elects early discontinuation from the study.● If on any analgesic medications, must have been taking a stable dose for at least 1 month prior to screening with no increase in dose leading up to study treatment. If the subject is on “as needed” or PRN analgesic medications, these may be continued during the study.

Exclusion Criteria

● Intra-articular injection within one month of Screening● Intra-articular injection with Zilretta within three months of screening● Any evidence of Serious coagulopathy● History of the hemorrhagic event within 6 months prior to screening● History of surgical hardware or other foreign bodies within the index knee joint. Hardware in the contralateral knee joint is permitted.● Instability or misalignment in the index joint post-repair● History of sensory peripheral neuropathy● If on opioids, the upper limit of allowed opioids is 30mg/day Morphine equivalent.● Substance use disorder