Sorrento Therapeutics Inc (NASDAQ: SRNE) announced that the company had received the Food and Drug Administration (FDA) green signal, allowing it to go ahead with the Phase 2 trial of a clinical study for RTX. The Phase 2 Trial of non-opioid product candidate resiniferatoxin (RTX) is for treating knee pain in steoarthritis (OA) patients.
Information about the Phase 2 Trial
The Phase 2 Trial will understand the impact and safety of the various dose groups of RTX used by patients to manage pain. Patients who suffer from moderate-to-severe osteoarthritis of the knee pain (OAK) are administered the RTX dose. The company has recorded the OA pain relief response that patients have demonstrated after being given the RTX.
Based on the observations, Sorrento Therapeutics Inc has concluded to include injectable corticosteroid as the active comparator in the current trial protocol. The RTX clinical development program will continue, with Phase 2 and 3 clinical trials planned in larger patient populations. The first Phase 2 trial will focus on identifying the recommended Phase 3 dose.
Based on Phase 1b trial observation results, Phase 2 study is initiated
The Phase 1b trial brought to light observations. Based on the conclusions, the Phase 2 study is initiated by Sorrento Therapeutics Inc. In the Phase 1b study, about 94 patients were involved. The company completed the study in one year.
The double-blinded, placebo-controlled ascending dose study in 94 patients included an open-label expansion cohort to assess the long-term safety and preliminary efficacy of a single intra-articular administration of RTX or saline control (as placebo group) treatment of moderate-to-severe pain due to osteoarthritis of the knee. As part of the Phase 1b study, patients were followed up today 84. Additionally, patients were given an option to remain under observation as part of follow-up for one year. The study found that pain relief was remarkably consistent among patients who responded to the initial treatment. Thus, fast pain relief in patients confirms the clinical potential of the RTX drug for long-term control of pain associated with osteoarthritis of the knee.