Sorrento Announces Phase 3 Trial Met Primary Endpoint and Key Secondary Endpoint in Mild or Moderate COVID-19 Adult Patients Treated with Ovydso (Olgotrelvir), an Oral Mpro Inhibitor as a Standalone Treatment for COVID-19
- In the phase 3 trial, a randomized double blind and placebo-controlled pivotal study, 1,212 mild or moderate COVID-19 patients were enrolled and treated with OVYDSO™ (Olgotrelvir) or placebo. The primary endpoint was time to sustained recovery of 11 COVID-19 related symptoms and the key secondary endpoint was the viral RNA copy load reduction.
- Ovydso significantly shortened clinical recovery time of 11 COVID-19 related symptoms by 2.4 days (8.6 days vs 11.0 days, HR 1.29/95%CI, P=0.0001) and reduced the viral RNA load at Day 4 (three days after treatment) by -0.80 log10 (p<0.0001) compared with the placebo group.
- Most adverse events (AEs) were mild and balanced between Ovydso group and placebo group. Among AEs >1%, nausea (1.5% vs 0.2%) and skin rash (3.3% vs 0.3%) were more frequent in the Ovydso group than in the placebo group.
- We have initiated communications with the China Health Authority (National Medical Products Administration, or NMPA) for a submission of a new drug application (NDA) and expedited review of the application based on the Phase 3 trial results.
- We also plan to open dialogue with other regulatory agencies around the world to discuss potential paths to approval.
SAN DIEGO, Sept. 12, 2023 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (OTC: SRNEQ, “Sorrento”) announced today positive topline results of a pivotal Phase 3 study of Sorrento’s oral Mpro inhibitor, Ovydso (Olgotrelvir, STI-1558), in mild or moderate symptomatic adults infected with SARS-CoV-2, or COVID-19, irrespective of risk factors for severe complications. Ovydso is an Oral Mpro Inhibitor as a standalone treatment for COVID-19 meaning it does not require co-administration with other agents. The Phase 3 study results met the primary endpoint of time to sustained recovery of 11 COVID-19 symptoms, as well as the key second endpoint of the viral RNA copy load reduction at Day 4 (after three-day treatment).
In this phase 3 trial, 1,212 patients were enrolled in China between February 2023 and June 2023, and 98.7% of the patients were vaccinated or previously infected with SARS-CoV-2. All patients were treated in an out-patient setting and received 600 mg BID of Ovydso for 5 days as a standalone treatment or placebo. The median time to sustained recovery of 11 COVID symptoms was 8.6 days in comparison with 11.0 days in the placebo group (HR 1.29/95% CI, p=0.0001). Ovydso also demonstrated profound antiviral activity in COVID-19 patients at Day 4 (three days after treatment), reducing the viral RNA copy load by -0.8 log10 (p< 0.0001) compared with placebo group. Results of subgroup analyses were largely consistent with these overall results. In patients with risk factors for severe COVID-19, Ovydso improved recovery time by 2.3 days (7.6 days vs 9.9 days, HR 1.36/95% CI, p= 0.026) and reduced viral RNA copy load by -1.10 log10 (p<0.0001) at Day 4, compared with the placebo group.
A total of 327 Treatment–Emergent Adverse Events (TEAEs) were reported in 1,212 patients (27.0%). Among them, 188 of 606 (31.0%) were in the Ovydso group and 139 of 606 (22.9%) were in the placebo group. Most TEAEs were mild and balanced between the Ovydso group and the placebo group. Nausea (1.5 % vs 0.2%) and skin rash (3.3% vs 0.3%) were the only two AEs that occurred with >1.0% with higher incidence in the Ovydso group than in the placebo group. No metallic taste was reported in the Ovydso group. Very few serious AEs were reported (4 in placebo and 3 in Ovydso), which were not related to the drug. The Phase 3 study was conducted at 25 sites in China, led by Dr. Hongzhou Lu, Fellow of the American Society for Microbiology, Professor and Dean of Shenzhen Third Hospital and co-led by Dr. Ronmeng Jiang, Professor and Deputy Dean of Beijing DiTan Hospital. Sorrento has initiated communications with the NMPA for an NDA submission and potential approval in China. Sorrento plans to open discussions with other regulatory authorities worldwide to discuss the potential path required for each particular authority for a full approval of Ovydso.
“We are very excited to see that the phase 3 results met the primary and key secondary endpoints. When the data are finalized, we look forward to working closely with the NMPA to submit an NDA, aiming to deliver Ovydso as a potential stand-alone treatment for COVID-19 patients as rapidly as possible,” stated Henry Ji, Ph.D., Chairman and Chief Executive Officer of Sorrento.
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 next-generation tyrosine kinase inhibitors ("TKIs"), 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 STI-1558, 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 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 postherpetic 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 3 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.
For more information visit www.sorrentotherapeutics.com
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 Sorrento’s products, technologies and prospects, statements regarding Ovydso, the potential appropriateness of Ovydso as a standalone treatment for COVID-19, Sorrento’s plans regarding submission of an NDA with NMPA and any potential plans to open dialogue and discussions with regulatory authorities worldwide to discuss the paths to approval of Ovydso. 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 safety and efficacy of Ovydso and seeking regulatory approval for Ovydso; 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, including those for Ovydso, 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 relating to the voluntary proceedings under Chapter 11 in the Bankruptcy Court (the "Chapter 11 Cases"), Sorrento's ability to continue operating in the ordinary course while the Chapter 11 Cases are pending, the timing and outcome of the Chapter 11 Cases, Sorrento's ability to obtain timely approval by the Bankruptcy Court of the motions filed in the Chapter 11 Cases, employee attrition and Sorrento's ability to retain senior management and other key personnel due to the distractions and uncertainties of the Chapter 11 Cases, Sorrento's ability to maintain relationships with suppliers, customers, employees and other third parties and regulatory authorities as a result of the Chapter 11 Cases, the Bankruptcy Court's rulings in the Chapter 11 Cases, the length of time that Sorrento will operate under Chapter 11 protection and the continued availability to Sorrento of operating capital during the pendency of the Chapter 11 Cases, risks associated with any third party motions in the Chapter 11 Cases, increased administrative and legal costs related to the chapter 11 process, exposure to potential litigation and inherent risks involved in a bankruptcy process, the potential adverse effects of the Chapter 11 Cases on Sorrento's liquidity or results of operations, or Sorrento's ability to timely file its periodic reports or meet periodic reporting requirements with the SEC; 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, 2022 and subsequent Quarterly Reports on Form 10-Q 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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