Sorrento Therapeutics Inc (NASDAQ: SRNE) announced that the company received a clearance from FDA (The U.S Food and Drug Administration) to proceed with the phase 2 trial of Non-Opioid Product Candidate Resiniferatoxin (RTX) for moderate to severe (OAK) osteoarthritis of the knee pain.
Phase 1 provides efficacy: As per the announcement based on data pf phase 1 trial of RTX, it demonstrated the safety of the product without DLT (Dose Limiting Toxicity) up to 30 ug. In addition, the report based on the phase 1 trial also indicates RTX (Resiniferatoxin), a unique treatment for long-term control of OAK. Sorrento Therapeutics further said that the patient observed significant pain relief and sustained relief beyond six months.
Proceed with Phase 2: On the back of the efficacy and safety of RTX, FDA clears the phase 2 trial of RTX. The phase 2 study will follow the data analyzed based on the observations of phase 1b, which lasted until February 2021. Now, phase 2 will assess the safety and efficacy of several dose groups of Resinferatoxin to manage OAK pain in moderate to severe patients. Sorrento Therapeutics further indicated that the superiority of data generated by RTX so far, against the current usage of the drug in the market, could help the company apply for registration in Europe and is also required for pricing purposes in the region.
As per Sorrento Therapeutics, quicker relief and durability of the RTX effect (more than 84 days) confirms the potential of Resiniferatoxin drug for the long term control of pain associated with knee, i.e. OAK (Osteoarthritis of the knee pain). Therefore, the company will continue with the RTX development program, with the phase 2 and phase 3 trials are expected to be conducted on a more extensive patient set. Initially, the phase 2 trial will focus on identifying the dose for the phase 3 trial.