Lakefront Biotherapeutics NV 6-K, filed Nov 29, 2021
Lakefront Biotherapeutics NV (LKFT)
About this 6-K
Lakefront Biotherapeutics NV filed this 6-K on November 29, 2021.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of November 2021
Commission File Number: 001-37384
GALAPAGOS NV
(Translation of registrant's name into English)
Generaal De Wittelaan L11 A3 2800 Mechelen, Belgium
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F [ X ] Form 40-F [ ]
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):
Note: Regulation S-T Rule 101(b)(1) only permits the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security holders.
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):
Note: Regulation S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which the registrant is incorporated, domiciled or legally organized (the registrant's "home country"), or under the rules of the home country exchange on which the registrant's securities are traded, as long as the report or other document is not a press release, is not required to be and has not been distributed to the registrant's security holders, and, if discussing a material event, has already been the subject of a Form 6-K submission or other Commission filing on EDGAR.
The information contained in this Report on Form 6-K, including Exhibit 99.1, except for the quote of Dr. Walid Abi-Saab contained in Exhibit 99.1, is hereby incorporated by reference into the Company’s Registration Statements on Forms F-3 (File No. 333-230639) and S-8 (File Nos. 333-204567, 333-208697, 333-211834, 333-215783, 333-218160, 333-225263, 333-231765 and 333-249416).
On November 22, 2021, the Registrant issued a press release, a copy of which is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
(c) Exhibit 99.1. Press release dated November 22, 2021
SIGNATURES
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.
| GALAPAGOS NV | ||
| (Registrant) | ||
| Date: November 29, 2021 | /s/ MARIE-THÉODORA VANDEWIELE | |
| Marie-Théodora Vandewiele | ||
| Company Secretary | ||
EXHIBIT 99.1
Galapagos completes patient recruitment for MANGROVE Phase 2 trial with GLPG2737 in polycystic kidney disease
Mechelen, Belgium; 22 November 2021, 22.01 CET; Galapagos NV (Euronext & NASDAQ: GLPG) announces completion of recruitment in the MANGROVE Phase 2 trial with investigational CFTR inhibitor GLPG2737 in patients with autosomal dominant polycystic kidney disease (ADPKD).
MANGROVE is a randomized, double-blind, placebo-controlled trial evaluating a once-daily oral dose of GLPG2737 (NCT04578548). The drug candidate or placebo is administered for 52 weeks, followed by an open-label extension period of 52 weeks, in 66 ADPKD patients with rapidly progressing disease. Patients are randomized in a 2:1 ratio of treatment to placebo. Primary objectives of the trial are to assess the effect on growth of total kidney volume over 52 weeks compared to placebo as well as overall safety and tolerability. Secondary objectives include renal function, pharmacokinetics, and pharmacodynamics. Recruitment for the MANGROVE trial was conducted in 7 countries in Europe.
GLPG2737 is a CFTR1 inhibitor which was observed to be well tolerated by patients in previous clinical trials. It is hypothesized that inhibition of the CFTR channel might reduce cyst growth and kidney enlargement for patients with ADPKD.
Galapagos expects topline results from the MANGROVE Phase 2 trial in the first half of 2023.
“We thank the ADPKD community for participating in the MANGROVE Phase 2 trial with GLPG2737,” said Dr. Walid Abi-Saab, Chief Medical Officer of Galapagos. “Polycystic kidney disease patients have a real need for new therapy options. We hope to learn in 2023 from this trial what CFTR modulation may be able to achieve against ADPKD, in our mission to bring new medicines to kidney disease patients.”
About
ADPKD
Autosomal dominant polycystic kidney disease affects approximately 12.5 million
people worldwide and is the fourth leading cause of kidney failure today.2 Typically
with this disease, both kidneys enlarge with fluid-filled cysts, leading to kidney failure
for approximately half of patients by the age of 60 and requiring dialysis and possibly kidney
transplantation.3 Patients may also suffer from hypertension, abdominal pain,
kidney infections, cyst ruptures, bleeding, and other symptoms impacting quality of life.
Other organs may be affected as well. Treatment is aimed at relieving symptoms and controlling
the accompanying hypertension. Currently, only one therapy (tolvaptan) is available to slow
down the progression of cyst development and renal insufficiency; however, not all patients
tolerate this therapy.4
About
Galapagos
Galapagos NV discovers, develops, and commercializes small molecule medicines
with novel modes of action. Our pipeline comprises discovery through Phase 3 programs in
inflammation, fibrosis, and other indications. Our ambition is to become a leading global
biopharmaceutical company focused on the discovery, development, and commercialization of
innovative medicines. More information is available at www.glpg.com.
Contacts
Investors:
Elizabeth
Goodwin
VP Investor Relations
+1 781 460 1784
Sofie
Van Gijsel
Senior Director Investor Relations
+1 781 296 1143
Sandra
Cauwenberghs
Director Investor Relations
+32 495 58 46 63
ir@glpg.com
Media:
Anna
Gibbins
Senior Director Therapeutic Areas Communications
+44 7717 801900
Evelyn
Fox
Director Executive Communications
+31 65 3591 999
communications@glpg.com
Forward-looking statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks, uncertainties and other factors that could cause actual results to differ materially from those referred to in the forward-looking statements and, therefore, the reader should not place undue reliance on them. These risks, uncertainties and other factors include, without limitation, the risk that ongoing and future clinical studies with GLPG2737 may not be completed in the currently envisaged timelines or at all, the inherent uncertainties associated with competitive developments, clinical trial and product development activities and regulatory approval requirements (including that data from the ongoing and planned clinical research programs may not support registration or further development of GLPG2737 due to safety or efficacy concerns or other reasons), Galapagos' reliance on collaborations with third parties, and that Galapagos’ estimations regarding its GLPG2737 development program, regarding the potential value of CFTR inhibition as a mechanism to treat ADPKD, and regarding the commercial potential of GLPG2737, may be incorrect, as well as those risks and uncertainties identified in our Annual Report on Form 20-F for the year ended 31 December 2020 and our subsequent filings with the SEC. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The forward-looking statements contained herein are based on management’s current expectations and beliefs and speak only as of the date hereof, and Galapagos makes no commitment to update or publicly release any revisions to forward-looking statements in order to reflect new information or subsequent events, circumstances or changes in expectations.
1
Cystic Fibrosis Transmembrane Conductance Regulator
2 Chebib
F.T., Torres V.E. Autosomal Dominant Polycystic Kidney Disease: Core Curriculum 2016. Am
J Kidney Dis. May 2016, 67 (5) 792-810
3 Parfrey P.S., Bear J.C., Morgan
J., Cramer B.C., McManamon P.J., Gault M.H., et al. The diagnosis and prognosis of autosomal
dominant polycystic kidney disease. N Engl J Med. 1990;323(16):1085–90
4
Chebib F.T., Perrone R.D., Chapman A.B., Dahl N.K., Harris P.C., Mrug M., et al. A
Practical Guide for Treatment of Rapidly Progressive ADPKD with Tolvaptan. JASN. October
2018, 29 (10) 2458-2470