GILEAD AND GALAPAGOS REPORT UPDATED SAFETY INFORMATION FOR FILGOTINIB IN RHEUMATOID ARTHRITIS (RA)

 

Gilead Sciences, Inc. (NASDAQ: GILD) and Galapagos NV (Euronext & NASDAQ: GLPG) today also announced interim safety information from four studies of the investigational compound filgotinib for the treatment of rheumatoid arthritis (RA). The data include 24 week results of the ongoing Phase 3 FINCH 1, 2, and 3 trials, and updated Week 156 safety data from the Phase 2b DARWIN 3 long term extension study in patients with RA.

Week 24 safety data from the FINCH 1, 2, and 3 studies are aggregated and summarized in the table below. Data from 3,452 patients are reported, including 2,088 patients who received filgotinib.

 

Placebo/

csDMARD

N= 1039

No. (%)

Adalimumab

+ MTX

40mg EOW

N=325

No. (%)

Filgotinib 100 mg +MTX/csDMARD

N=840

No. (%)

Filgotinib 200 mg +MTX/csDMARD

N=1038

No. (%)

Filgotinib 200 mg

N=210

No. (%)

Filgotinib Total

N=2088

No. (%)

Serious infections&

 10 (1.0)

8 (2.5)

13 (1.5)

13 (1.3)

3 (1.4)

29 (1.4)

Herpes zoster&

4 (0.4)

2 (0.6)

5 (0.6)

6 (0.6)

1 (0.5)

12 (0.6)

DVT/PE&

3 (0.3)

0 (0)

0 (0)

1 (0.1)µ

0 (0)

1 (<0.1)

Death@

2 (0.2)

0 (0)

1 (0.1)

3 (0.3)

0 (0)

4 (0.2)

Malignancy excluding NMSC&

4 (0.4)

1 (0.3)

1 (0.1)

0 (0)

0 (0)

1 (<0.1)

MACE&

5 (0.5)

1 (0.3)

2 (0.2)

2 (0.2)

1 (0.5)

5 (0.2)

 

MTX, methotrexate; EOW, every other week; csDMARD, conventional synthetic disease-modifying antirheumatic drug; DVT, deep venous thrombosis; PE, pulmonary embolism; NMSC, non-melanoma skin cancer; MACE, major adverse cardiac events

& Treatment-emergent events

µ Excludes one retinal vein occlusion

@ All events

The Phase 2b DARWIN 3 long term extension trial initially enrolled 739 patients, who received filgotinib 100 mg twice daily, 100 mg or 200 mg once daily. Safety data are summarized in the table below. Results represent treatment through 156 weeks or longer, and comprise 2,203 patient-years of exposure (PYE) to filgotinib.

 

Number of Events

(Events per 100 Patient-Years)

PYE=2,203

Serious infections

27 (1.2)

Herpes zoster

34 (1.5)

DVT/PE

2 (0.1)

Death

5 (0.2)

Malignancy excluding NMSC

11 (0.5)

MACE

3 (0.1)

DVT, deep venous thrombosis; PE, pulmonary embolism; NMSC, non-melanoma skin cancer; MACE, major adverse cardiac events

 

"The growing body of evidence from both the DARWIN 3 long-term extension trial combined with the results of the FINCH 1, 2, and 3 trials, represent a larger safety database in a broader population of RA patients, spanning from those who are treatment-naive to those who have failed biologics," said John McHutchison, AO, MD, Chief Scientific Officer, Head of Research and Development, Gilead Sciences.

 

"The available safety data from the FINCH and DARWIN 3 studies, which together included more than 2,700 patients receiving filgotinib, suggest that filgotinib has the potential to deliver a much needed option for treating people living with RA," said Dr. Walid Abi-Saab, Chief Medical Officer, Galapagos.

 

Filgotinib is an investigational agent and not approved anywhere globally. Its efficacy and safety have not been established.

Note

About the FINCH program

The FINCH Phase 3 program is investigating the efficacy and safety of 100 mg and 200 mg filgotinib once daily, in RA patient populations ranging from early stage to biologic-experienced patients. FINCH 1 is a 52-week, randomized, placebo- and adalimumab-controlled trial in combination with methotrexate (MTX) enrolling 1,759 adult patients with moderately to severely active RA who have had inadequate response to MTX. The primary endpoint is ACR20 at week 12. The trial includes radiographic assessment at weeks 24 and 52. FINCH 2 was a 24-week, randomized, placebo-controlled trial in 449 patients who were receiving conventional disease-modifying anti-rheumatic drugs (cDMARD), and had a prior inadequate response to one or more biological therapies. The primary endpoint was ACR20 at week 12. FINCH 3 is a 52-week, randomized trial in 1,252 MTX-naïve patients to study filgotinib in combination with MTX, as well as monotherapy. The primary endpoint is ACR20 at week 24. Radiographic progression is also being assessed.

 

About the DARWIN 3 program

DARWIN 3 is an ongoing multi-center, open-label, long-term follow-up safety and efficacy trial of subjects who completed either DARWIN 1 or DARWIN 2, which were double-blind, placebo-controlled Phase 2b trials for 24 weeks of treatment in patients with moderate to severe RA who showed an inadequate response to methotrexate. DARWIN 1 (594 patients) evaluated filgotinib as an addition to methotrexate, as once- and twice-daily administration (once-daily and twice-daily dosing, respectively) at three daily dose levels. DARWIN 2 (283 patients) evaluated filgotinib as once-daily monotherapy administration (once-daily dosing) at three dose levels. Both DARWIN 1 and DARWIN 2 achieved the primary endpoints (ACR20).  

 

More information about clinical trials with filgotinib can be accessed at: www.clinicaltrials.gov.

 

About the Galapagos - Gilead Collaboration

Galapagos and Gilead entered into a global collaboration for the development and commercialization of filgotinib in inflammatory indications.  The FINCH studies are among several clinical trials of filgotinib in inflammatory diseases, including the EQUATOR Phase 2 program in psoriatic arthritis, the TORTUGA study in ankylosing spondylitis, the DIVERSITY Phase 3 trial in Crohn's disease (also small bowel and fistulizing Crohn's disease Phase 2 studies) and the Phase 3 SELECTION trial in ulcerative colitis.

 

About Galapagos

Galapagos (Euronext & NASDAQ: GLPG) discovers and develops small molecule medicines with novel modes of action, three of which show promising patient results and are currently in late-stage development in multiple diseases. Our pipeline comprises Phase 3 through to discovery programs in inflammation, fibrosis, osteoarthritis 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 at www.glpg.com.

 

This press release contains inside information within the meaning of Regulation (EU) No 596/2014 of the European Parliament and of the Council of 16 April 2014 on market abuse (market abuse regulation).

 

About Gilead Sciences

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California. For more information on Gilead Sciences, please visit the company's website at www.gilead.com.

 

 

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