GAITHERSBURG, Md., Aug. 12, 2020 (GLOBE NEWSWIRE) -- Viela Bio (NASDAQ:VIE), a biotechnology company dedicated to the discovery, development and commercialization of novel treatments for autoimmune and severe inflammatory diseases, today reported financial results and provided program highlights for the second quarter ended June 30, 2020.
"Viela had another productive quarter marked by the U.S. FDA approval of UPLIZNA™—also known as inebilizumab—in the U.S.," said Bing Yao, Ph.D., Chief Executive Officer at Viela Bio. "In parallel, we continue to advance the development of inebilizumab in the U.S. in additional indications such as myasthenia gravis and IgG4-related disease."
Added Dr. Yao: "Beyond UPLIZNA™, we continue to make progress throughout our entire pipeline. We recently reported positive interim Phase 1b data from our ongoing trial with VIB7734 and selected systemic lupus erythematosus as our area of focus for a Phase 2 trial. Separately, we are planning to initiate a Phase 1 trial with this product candidate in patients with COVID-19-related acute lung injury. Looking toward our objectives for the rest of the year and beyond, we are well-positioned having recently raised gross proceeds of approximately $169 million in an underwritten public offering, which will support our clinical and commercial execution and extends our cash runway into 2023."
PROGRAM HIGHLIGHTS
UPLIZNA™ (inebilizumab-cdon)
- UPLIZNA™ Commercial Launch Underway
On June 11, the U.S. Food and Drug Administration (FDA) approved UPLIZNA™ for the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-AQP4 antibody positive as a twice-a-year maintenance regimen following initial doses. UPLIZNA™ is the first and only treatment designed to deplete B cells that is approved by the FDA for this patient population. Commercial launch activities are currently underway, with focus on both centers of excellence and community neurologists throughout the U.S.
- Viela Preparing for Additional Clinical Trials with Inebilizumab
Phase 3 trials of inebilizumab in myasthenia gravis and IgG4-related disease are projected to initiate in Q4 2020. The Company is also conducting a Phase 2 trial for kidney transplant desensitization, which due to the COVID-19 pandemic, remains voluntarily paused.
VIB4920
- Viela Resumes New Patient Enrollment in Ongoing Trial with VIB4920
Viela is currently conducting a Phase 2b trial with VIB4920 in Sjögren's syndrome as well as a Phase 2 trial in patients with kidney transplant rejection. Due to the COVID-19 pandemic, new patient enrollment in both trials had been voluntarily paused, but has recently resumed in the kidney transplant rejection trial, with enrollment in the Sjögren's trial anticipated to resume in Q4 2020. The Company continues to explore other potential indications associated with the CD40/CD40L co-stimulatory pathway for potential additional clinical studies.
VIB7734
- Viela Prepares for New Study in COVID-19-Related Acute Lung Injury
Viela is planning to initiate a Phase 1 study in Q3 2020 with VIB7734 in patients with COVID-19-related acute lung injury. Results from this study are anticipated in Q1 2021, at which time the Company will decide whether to pursue additional clinical trials in this indication.
FINANCIAL RESULTS
Conference Call and Webcast
The Company will host a live webcast and conference call to discuss financial results and program highlights for the second quarter of 2020 today at 5:00 p.m. EDT.
The archived webcast will be available for replay on the Viela Bio website approximately two hours after the event.
Statements of Operations and Comprehensive Loss
(Unaudited)
(In thousands, except share and per share amounts)
Balance Sheets
(Unaudited)
(In thousands, except share and per share amounts)
Source: Viela Bio
Contacts: Investors: Solebury Trout Chad Rubin 646-378-2947 [email protected] Media: Solebury Trout Amy Bonanno 914-450-0349 [email protected]
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