Sorrento Announces Full Enrollment of Phase I Study of Intranasal STI-9199 (COVISHIELD™ IN), a Potent Neutralization Antibody Against Omicron BA.2 and All Variants of Concern
05/02/2022 - 09:00 AM
The Phase I safety and pharmacokinetic study in 24 healthy volunteers has completed enrollment. The study is still blinded, but only 5 minor adverse events requiring no treatment have been reported in the entire study to date, similar to the safety profile observed in Sorrento’s COVIDROPSTM (STI-2099) product candidate in Phase I and two Phase II studies (US and UK). STI-9199 has demonstrated in vitro and in vivo activity against all SARS-CoV-2 variants of concern, including the Omicron strain BA.1, Omicron BA.1.1 and Omicron BA.2. Separate Phase II/III pivotal studies in mild to moderate COVID-19 patients is planned in the US, China and Mexico for Emergency Use Authorization (EUA) submissions. STI-9199 has the potential to address the significant unmet medical need in the multi-billion dollar market of neutralization antibody (nAb) for COVID-19 for rapid outpatient treatment immediately upon detection effective across all variants of concern (Most of the EUA-approved nAbs are no longer active against the Omicron variants, other than a single EUA-approved nAb that is still on the market.) SAN DIEGO, May 02, 2022 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today announced that its Phase I study of intranasal (IN) STI-9199 (COVISHIELDTM IN) has been fully enrolled in healthy volunteers. The study is currently still blinded and ongoing. The safety profile of STI-9199 (COVISHIELDTM IN) to date is similar to Sorrento’s Phase II compound STI-2099 (COVIDROPSTM ) with only transient adverse events, mild in severity and requiring no treatment. This was expected given that in nearly 300 patients treated with COVIDROPSTM , a benign safety profile was also observed.
The Phase II/III studies are expected to be conducted in several countries (USA, China and Mexico). Sorrento plans to discuss with the FDA and other regulatory authorities the most appropriate end-points for the pivotal study that could result in an EUA, assuming the trials meet the efficacy end-points of the pivotal study.
The neutralizing antibody of STI-9199 is delivered as drops into the nose and, unlike most of the EUA-approved intravenously administered neutralizing antibodies, it has demonstrated in vitro and in vivo activity against the Omicron BA.2 variant, as well as all other SARS-CoV-2 variants of concern. This intranasal approach has the potential to target Omicron in the upper airways and lungs. Although several neutralizing antibodies were shown to be quite effective during the initial outbreak of COVID-19, the initially EUA-cleared antibodies have had to be withdrawn from the market due to their lack of activity against the Omicron variants, and only a single EUA antibody, delivered by intravenous injection, is still available on the market for COVID-19 patients in need.
“We are encouraged by the speed with which this study enrolled, as the IND was just cleared two months ago,” said Dr. Mike Royal, Chief Medical Officer of Sorrento. “We anticipate the Phase II/III studies will enroll very quickly given the significant increase in BA.2 cases worldwide and the non-invasive treatment approach. These studies have the potential to support EUA submission in the near future”.
About Sorrento Therapeutics, Inc.
Sorrento is a clinical and commercial stage biopharmaceutical company developing new therapies to treat cancer, pain (non-opioid treatments), autoimmune disease and COVID-19. Sorrento's multimodal, multipronged approach to fighting cancer is made possible by its extensive immuno-oncology platforms, including key assets such as fully human antibodies (“G-MAB™ library”), immuno-cellular therapies (“DAR-T™”), antibody-drug conjugates (“ADCs”), and oncolytic virus (“Seprehvec™”). Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including Abivertinib, COVISHIELD™, and COVI-MSC™; and diagnostic test solutions, including COVIMARK™.
Sorrento's commitment to life-enhancing therapies for patients is also demonstrated by our effort to advance a first-in-class (TRPV1 agonist) non-opioid pain management small molecule, resiniferatoxin (“RTX”), and SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (SEMDEXA™), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, and to commercialize ZTlido® (lidocaine topical system) 1.8% for the treatment of post-herpetic neuralgia (PHN). RTX has been cleared for a Phase II trial for intractable pain associated with cancer and a Phase II trial in osteoarthritis patients. Positive final results from the Phase III Pivotal Trial C.L.E.A.R. Program for SEMDEXA™, its novel, non-opioid product for the treatment of lumbosacral radicular pain (sciatica), were announced in March 2022. ZTlido® was approved by the FDA on February 28, 2018.
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Forward-Looking Statements
This press release and any statements made for and during any presentation or meeting contain forward-looking statements related to Sorrento Therapeutics, Inc., under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding STI-9199 (COVISHIELDTM IN); the therapeutic and clinical potential of STI-9199 and its potential ability to address unmet medical needs; the potential safety and efficacy of STI-9199 and STI-2099, including STI-9199’s potential efficacy against variants of concern and Omicron strains and its potential to target Omicron in the upper airways and lungs; the preclinical and clinical testing of STI-9199 and STI-2099; Sorrento’s expectations regarding the Phase II/III studies to evaluate STI-9199, including with respect to the locations for such studies, the end-points of such studies and the expected timing for enrollment; Sorrento’s plans to discuss with FDA the endpoint criteria for a pivotal study that could result in an EUA for STI-9199 and the timing for any potential EUA submission; and Sorrento’s position in the antiviral industry. Risks and uncertainties that could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements, include, but are not limited to: risks related to Sorrento's technologies and prospects, including, but not limited to risks related to seeking regulatory approval for STI-9199; clinical development risks, including risks in the progress, timing, cost, and results of clinical trials and product development programs; risk of difficulties or delays in obtaining regulatory approvals; risks that clinical study results may not meet any or all endpoints of a clinical study and that any data generated from such studies may not support a regulatory submission or approval; risks that prior test, study and trial results may not be replicated in continuing or future studies and trials; risks of manufacturing and supplying drug product; risks related to leveraging the expertise of its employees, subsidiaries, affiliates and partners to assist Sorrento in the execution of its product candidates’ strategies; risks related to the global impact of COVID-19; and other risks that are described in Sorrento's most recent periodic reports filed with the Securities and Exchange Commission, including Sorrento's Annual Report on Form 10-K for the year ended December 31, 2021 filed with the Securities and Exchange Commission, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and we undertake no obligation to update any forward-looking statement in this press release except as required by law.
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Contact: Brian Cooleymediarelations@sorrentotherapeutics.com
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