- Massive Section 2 efficacy trial cleared to start out in the UK in newly recognized SARS-CoV-2 contaminated sufferers.
- COVI-DROPS is run by intranasal drops and the antibody is energetic in opposition to the unique SARS-CoV-2 virus, in addition to the UK/Alpha and India/Delta variants, at the moment prevalent within the UK and US.
SAN DIEGO, June 11, 2021 (GLOBE NEWSWIRE) — Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) at this time introduced that the Medicines and Healthcare merchandise Regulatory Company (MHRA), the UK’s regulatory company, has cleared Sorrento’s COVI-DROPS product candidate for a Section 2 efficacy trial. The applying was submitted as a rolling software and the MHRA cleared the research in lower than a month from Sorrento’s first submission to the MHRA. The applying was supported by the security knowledge from a wholesome topic research accomplished within the US, which confirmed a security profile akin to placebo with doses as much as 60 mg. On this research, there have been no critical antagonistic results or dose limiting toxicities and all antagonistic results have been delicate in severity. The utmost tolerated dose was not reached.
The Section 2 efficacy trial is a big double-blind scientific trial enrolling 350 outpatients with COVID-19 who’re asymptomatic or have delicate signs in a 2:2:1 randomization with sufferers receiving 10mg, 20mg or placebo (particulars may be discovered on www.ClinicalTrials.gov utilizing the identifier NCT04900428). This trial will complement the Section 2 trial at the moment being began within the US and a separate trial to be began in Mexico.
COVI-DROPS is run as an intranasal instillation in every nares to lately contaminated sufferers and makes use of the identical neutralizing antibody drug substance as COVI-AMG, the intravenous formulation. The antibody is energetic in opposition to the unique SARS-CoV-2 virus in addition to essentially the most prevalent viral variants of concern (VoCs) at the moment infecting the UK and the US. These variants embody the UK/Alpha and the India/Delta variants of concern.
The outcomes of this Section 2 trial within the UK might be mixed with the outcomes of the US and Mexico Section 2 trials and will the outcomes of those research reveal that COVI-DROPS is each protected and efficient in opposition to SARS-CoV-2, Sorrento will apply for Emergency Use Authorization within the US, India, UK, Mexico and European Union in addition to different territories.
About Sorrento Therapeutics, Inc.
Sorrento is a scientific stage, antibody-centric, biopharmaceutical firm creating new therapies to deal with cancers and COVID-19. Sorrento’s multimodal, multipronged method to combating most cancers is made potential by its intensive immuno-oncology platforms, together with key belongings reminiscent of absolutely human antibodies (“G-MAB™ library”), scientific stage immuno-cellular therapies (“CAR-T”, “DAR-T™”), antibody-drug conjugates (“ADCs”), and scientific stage oncolytic virus (“Seprehvir™”). Sorrento can also be creating potential antiviral therapies and vaccines in opposition to coronaviruses, together with COVIGUARD™, COVI-AMG™, COVISHIELD™, Gene-MAb™, COVI-MSC™ and COVIDROPS™; and diagnostic check options, together with COVITRACK™, COVISTIX™ and COVITRACE™.
Sorrento’s dedication to life-enhancing therapies for sufferers can also be demonstrated by our effort to advance a first-in-class (TRPV1 agonist) non-opioid ache administration small molecule, resiniferatoxin (“RTX”), and SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (SEMDEXA™), a novel, viscous gel formulation of a extensively used corticosteroid for epidural injections to deal with lumbosacral radicular ache, or sciatica, and to commercialize ZTlido® (lidocaine topical system) 1.8% for the therapy of post-herpetic neuralgia. RTX has accomplished a Section IB trial for intractable ache related to most cancers and a Section 1B trial in osteoarthritis sufferers. SEMDEXA is in a pivotal Section 3 trial for the therapy of lumbosacral radicular ache, or sciatica. ZTlido® was accepted by the FDA on February 28, 2018.
For extra data go to www.sorrentotherapeutics.com.
This press launch and any statements made for and through any presentation or assembly comprise forward-looking statements associated to Sorrento Therapeutics, Inc., underneath the protected harbor provisions of Part 21E of the Personal Securities Litigation Reform Act of 1995 and topic to dangers and uncertainties that might trigger precise outcomes to vary materially from these projected. Ahead-looking statements embody statements concerning the exercise of COVIDROPS in opposition to SARS-CoV-2, together with the unique SARS-CoV-2 virus, the UK/Alpha and the India/Delta variants, and some other VoCs; the anticipated variety of sufferers and doses within the deliberate Section 2 trial within the UK; the anticipated final result or outcomes of the Section 2 trials within the UK, the US and Mexico; the potential efficacy and security of COVIDROPS and Sorrento’s plans to use for Emergency Use Authorization within the US, India, UK, European Union or some other territories. Dangers and uncertainties that might trigger our precise outcomes to vary materially and adversely from these expressed in our forward-looking statements, embody, however are usually not restricted to: dangers associated to Sorrento’s applied sciences and prospects, together with, however not restricted to dangers associated to looking for regulatory approval for COVI-DROPS; scientific improvement dangers, together with dangers within the progress, timing, price, and outcomes of scientific trials and product improvement packages; danger of difficulties or delays in acquiring regulatory approvals; dangers that scientific research outcomes might not meet all or any endpoints of a scientific research and that any knowledge generated from such research might not help a regulatory submission or approval; dangers that prior check, research and trial outcomes is probably not replicated in future research and trials; dangers of producing and supplying drug product; dangers associated to leveraging the experience of its staff, subsidiaries, associates and companions to help Sorrento within the execution of its therapeutic antibody product candidate methods; dangers associated to the worldwide influence of COVID-19; and different dangers which can be described in Sorrento’s most up-to-date periodic reviews filed with the Securities and Change Fee, together with Sorrento’s Annual Report on Type 10-Ok for the yr ended December 31, 2020, and subsequent Quarterly Experiences on Type 10-Q filed with the Securities and Change Fee, together with the danger elements set forth in these filings. Buyers are cautioned to not place undue reliance on these forward-looking statements, which communicate solely as of the date of this launch and we undertake no obligation to replace any forward-looking assertion on this press launch besides as required by regulation.
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G-MAB™, DAR-T™, SOFUSA™, COVIGUARD™, COVI-AMG™, COVISHIELD™, Gene-MAb™, COVIDROPS™, COVI-MSC™, COVITRACK™, COVITRACE™ and COVISTIX™ are emblems of Sorrento Therapeutics, Inc.
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