SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): December 11, 2019
VIELA BIO, INC.
(Exact name of registrant as specified in its charter)
(State or other jurisdiction
|One Medimmune Way, First Floor, Area Two|
|(Address of principal executive offices)||(zip code)|
Registrants telephone number, including area code: (240) 558-0038
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
|Title of each class||Trading Symbol(s)||Name of each exchange on which registered|
|Common Stock, $0.001 par value per share||VIE||The Nasdaq Stock Market LLC|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging Growth Company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
|Item 7.01|| |
Regulation FD Disclosure.
On December 11, 2019, Viela Bio, Inc. (the Company) issued a press release entitled Viela Bio Announces Initiation of Phase 2b Trial of VIB4920 in Sjögrens Syndrome, which is attached here as Exhibit 99.1.
The information contained in this Item 7.01 and Exhibit 99.1 attached hereto is being furnished and shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the Exchange Act), or otherwise subject to the liabilities under that Section, nor shall it be deemed incorporated by reference into any registration statement or other filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
|Item 8.01|| |
On December 11, 2019, the Company announced that the first patient has been dosed in a Phase 2b trial of VIB4920 for the treatment of Sjögrens syndrome, which is a chronic, systemic autoimmune disease involving inflammation and destruction of the salivary and lacrimal glands which leads to severe dryness and chronic pain.
|Item 9.01|| |
Financial Statements and Exhibits.
|99.1||Press release dated December 11, 2019|
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|VIELA BIO, INC.|
|By:||/s/ Mitchell Chan|
Chief Financial Officer
Date: December 11, 2019
Viela Bio Announces Initiation of Phase 2b Trial of VIB4920 in Sjögrens Syndrome
Gaithersburg, MDDecember 11, 2019 Viela Bio (Nasdaq:VIE), a clinical-stage biotechnology company pioneering treatments for autoimmune and severe inflammatory diseases, today announced that the first patient has been dosed in a Phase 2b trial of VIB4920 for the treatment of Sjögrens syndromea chronic, systemic autoimmune disease involving inflammation and destruction of the salivary and lacrimal glands which leads to severe dryness and chronic pain.
Sjögrens is a common rheumatic disease for which there are currently no approved disease-modifying therapies. Patients with this disease suffer from debilitating fatigue and extensive mouth and eye dryness, and in some cases, lung and kidney disease as well as an increased risk of lymphoma, said Jorn Drappa, M.D., Ph.D., Chief Medical Officer, Head of Research and Development at Viela Bio. The initiation of this trial is an important milestone in our research and development efforts involving the CD40/CD40L co-stimulatory pathway. We believe that treatment with our product candidate VIB4920a fusion protein designed to bind to CD40Lcould address immune overactivation in T and B cell-driven diseases such as Sjögrens syndrome.
The Phase 2b trial is a randomized, double-blind and placebo-controlled trial designed to evaluate the efficacy and safety of VIB4920 in participants with Sjögrens syndrome. For additional information about this clinical trial, please visit clinicaltrials.gov, identifier NCT04129164.
VIB4920 is an investigational fusion protein designed to bind to CD40L, blocking the T cells interaction with CD40-expressing cells.
About Sjögrens Syndrome
Sjögrens syndrome is a chronic, systemic autoimmune disease characterized by lymphocytic infiltration of the exocrine glands such as the lacrimal and salivary glands. The disease frequently leads to keratoconjunctivitis sicca (dry eye) and xerostomia (dry mouth). Sjögrens syndrome may occur with other autoimmune diseases, such as systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA). No treatments have been shown to alter the course of this disease. Supportive treatment is aimed at relieving dry mouth/dry eye symptoms.
About Viela Bio
Viela Bio, headquartered in Gaithersburg, Maryland, is a clinical-stage biotechnology company pioneering treatments for autoimmune and severe inflammatory diseases. For more information, please visit www.vielabio.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical
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facts, contained in this press release, including statements regarding our strategy, future operations, prospects and plans; our expectations with respect to the potential regulatory approval of VIB4920 for the treatment of patients with Sjögrens syndrome; our planned and ongoing clinical trials for our product candidates and the potential advantages of those product candidates, including inebilizumab, VIB4920 for the treatment of patients with Sjögrens syndrome and VIB7734; the initiation, enrollment, timing, progress, release of data from and results of those planned and ongoing clinical trials; and our goals with respect to the development and potential use, if approved, of each of its product candidates are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as anticipate, believe, estimate, expect, intend, may, plan, predict, project, target, potential, will, would, could, should, continue or the negative of these terms or other comparable terminology, which are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. Various factors may cause differences between our expectations and actual results as discussed in greater detail in our filings with the Securities and Exchange Commission (SEC), including without limitation, the risks and uncertainties described in the section entitled Risk Factors in our Quarterly Report on Form 10-Q for the three months ended September 30, 2019, which was filed with the SEC on November 14, 2019. We do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
Source: Viela Bio Inc.
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