In a Jan. 23 research note, analyst Ram Selvaraju reported Sorrento Therapeutics Inc.'s (SRNE:NASDAQ) resiniferatoxin (RTX) demonstrated, in early Phase 1b data, proof-of-concept efficacy at the lowest dose. RTX is Sorrento's nonopioid, injected drug candidate for intractable pain.
The goal of the trial is to determine a clinically effective dose of RTX. As such, for the study, a total of 40 patients were recruited, eight for each of the five dose levels tested. In each group, six patients were administered RTX intra-articularly, and two were given a saline control. Patients are then monitored for 12 months post injection.
As for results overall, "no dose limiting toxicities have been observed to date at any dose group, and a majority of the patients treated with the active drug have reported positive clinical benefits in pain reduction," Selvaraju noted.
Regarding patients in the lowest dose cohort, those administered RTX received a single injection of 5 micrograms in the knee joint. Their data were unblinded, per protocol.
At Day 84 treated patients reported a pain score, based on the Western Ontario and McMaster Universities Osteoarthritis Index questionnaire, that was 4.7 points lower than in control arm patients. Pain began to subside as early as the first day after administration, and effects were sustained through the last day of observation. There was no evidence that any single patient had zero response to RTX treatment.
"We believe that the clear curve separation between drug and placebo, with no standard deviation overlap, indicates very compelling efficacy at the lowest dose," Selvaraju commented.
Patients in the higher dose cohorts are also showing "rapid and sustainable improvements," Selvaraju relayed, but those groups currently remain blinded. They are expected to be unblinded after 12 weeks, at the end of April 2019, and a second interim data release should follow about a month later.
Considering Sorrento's path to approval of RTX, H.C. Wainwright anticipates the company will have to conduct two independent pivotal trials. Further, because it likely will not have to test RTX in a dose-ranging Phase 2 study, based on results so far, it could move into the first pivotal study once it completes the Phase 1b currently underway.
H.C. Wainwright has a Buy rating and a target price of $40 per share on Sorrento. The target is nearly 18 times the current share price, which is around $2.26.[NLINSERT]
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Disclosures from H.C. Wainwright & Co., Sorrento Therapeutics Inc., Company Update, January 23, 2019
Investment Banking Services include, but are not limited to, acting as a manager/co-manager in the underwriting or placement of securities, acting as financial advisor, and/or providing corporate finance or capital markets-related services to a company or one of its affiliates or subsidiaries within the past 12 months.
I, Raghuram Selvaraju, Ph.D., certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies.
None of the research analysts or the research analyst's household has a financial interest in the securities of Sorrento Therapeutics Inc. (including, without limitation, any option, right, warrant, future, long or short position).
As of December 31, 2018 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Sorrento Therapeutics Inc.
Neither the research analyst nor the Firm has any material conflict of interest in of which the research analyst knows or has reason to know at the time of publication of this research report.
The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services.
The Firm or its affiliates did not receive compensation from Sorrento Therapeutics Inc. for investment banking services within twelve months before, but will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report.
The Firm does not make a market in Sorrento Therapeutics Inc. as of the date of this research report.
H.C. Wainwright & Co., LLC and its affiliates, officers, directors, and employees, excluding its analysts, will from time to time have long or short positions in, act as principal in, and buy or sell, the securities or derivatives (including options and warrants) thereof of covered companies referred to in this research report.