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Poster Session B - Monday Morning

Category: IBD

B0375 - Efficacy and Safety of Upadacitinib Induction Therapy in Patients With Moderately to Severely Active Crohn’s Disease: Results From a Randomized Phase 3 U-EXCEL Study

Monday, October 24, 2022

10:00 AM – 12:00 PM ET

Location: Crown Ballroom

Has Audio

Presenting Author(s)

EL

Edward V. Loftus, Jr., MD, FACG

Mayo Clinic College of Medicine and Science
Rochester, Minnesota

Edward V. Loftus, MD, FACG¹, Jean-Frederic Colombel, MD², Ana Paula Lacerda, MD, MSc³, Laurent Peyrin-Biroulet, MD⁴, Geert D’Haens, MD⁵, Remo Panaccione, MD⁶, Walter Reinisch, MD, PhD⁷, Edouard Louis, MD⁸, Minhu Chen, MD⁹, Hiroshi Nakase, MD¹⁰, Susan Greenbloom, MD¹¹, George DuVall, MD¹², Yuri Sanchez-Gonzalez, PhD³, Mohamed-Eslam Mohamed, PhD³, Susan Rhee, MD³, Tian Feng, PhD³, Elena Dubcenco, MD³, Julian Panés, MD, PhD¹³
¹Mayo Clinic College of Medicine and Science, Rochester, MN; ²Icahn School of Medicine at Mount Sinai, New York, NY; ³AbbVie, Inc., North Chicago, IL; ⁴University Hospital of Nancy, Lorraine University, Vandoeuvre, Franche-Comte, France; ⁵Amsterdam University Medical Centres, Amsterdam, Zuid-Holland, Netherlands; ⁶University of Calgary, Calgary, AB, Canada; ⁷Medical University of Vienna, Vienna, Wien, Austria; ⁸University Hospital CHU of Liège, Liège, Liege, Belgium; ⁹The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China; ¹⁰Sapporo Medical University School of Medicine, Sapporo, Kyoto, Japan; ¹¹Toronto Digestive Disease Associates, Woodbridge, ON, Canada; ¹²CHRISTUS Trinity Clinic, Tyler, TX; ¹³Formerly, Hospital Clínic de Barcelona, IDIBAPS, CIBERehd, Barcelona, Catalonia, Spain

Introduction: Eligible patients(N=526) with moderate to severe active Crohn’s Disease(CD), defined as average daily stool frequency(SF)≥4 and/or abdominal pain score(APS)≥2, and a Simple Endoscopic Score for CD(SES-CD) (excluding the narrowing component subscore) ≥6(≥4 for subjects with isolated ileal disease).

Methods: Patients(pts) were randomized 2:1 to UPA45 or PBO for 12 weeks(wks). Pts on baseline corticosteroids(CS) initiated a protocolized tapering at wk4. The co-primary endpoints, clinical remission(per CDAI for US [CDAI< 150] or per SF/APS for EU [average daily SF ≤2.8 and APS≤1.0 and neither greater than baseline [BL]) and endoscopic response(decrease in SES-CD >50% from BL or ≥2-point reduction from BL for pts with a BL SES-CD=4), were evaluated at wk 12. Safety, primary and key secondary clinical, and endoscopic outcomes were evaluated through wk 12.

Results: BL demographics and characteristics were similar between groups; 45.4% of pts had a history of prior biologic use or failure. At wk 12, significantly more pts receiving UPA45 vs PBO achieved the co-primary endpoints: clinical remission(per CDAI, UPA45 49.5% vs PBO 29.1%; per SF/APS, UPA45 50.7% vs PBO 22.2%) and endoscopic response (UPA45 45.5% vs PBO 13.1%) (P< .0001 for all endpoints; Table 1). UPA45 was superior to PBO for most of the ranked secondary endpoints including clinical remission per CDAI and SF/APS at wk 4, CS-free clinical remission per CDAI and SF/APS at wk 12, clinical response(CR-100; 100-point decrease in CDAI from BL at wk 2 and wk 12, and endoscopic remission at wk 12(P< .0001 or P< .01, Table 1). Severe AEs occurred at 8.9% and 8.5% within UPA45 and PBO groups, respectively. The most common AEs(≥5% of pts) were acne and anemia among pts treated with UPA, and CD exacerbation among pts receiving PBO. Serious infections were 1.1% and 1.7% for UPA45 and PBO groups, respectively. Herpes zoster(2.9%) was reported in the UPA45 group only, and an adjudicated cardiovascular event(0.6%) was reported only in the PBO group. No treatment-emergent deaths, malignancies, other opportunistic infections, adjudicated gastrointestinal perforations or adjudicated thrombotic events were reported in either group.

Discussion: UPA45 induction therapy was superior to PBO in achieving early response, including clinical remission, endoscopic response, and CS-free clinical remission during the U-EXCEL study. UPA45 was well tolerated, with no new safety risks and a safety profile comparable to previous UPA studies.

Endpoint

PBO

(N=176)

% [95% CI]^g

UPA 45 mg QD

(N=350)

% [95% CI]^g

Difference vs. PBO

% [95% CI]^h

Co-Primary Endpoints

Clinical remission, wk 12

Per CDAI^a

Per SF/APS^b

29.1 [22.4, 35.8]

22.2 [16.0, 28.3]

49.5 [44.2, 54.8]

50.7 [45.5, 56.0]

20.8 [12.7, 28.8]**

28.7 [20.9, 36.4]**

Endoscopic response^c, wk 12

13.1 [8.1, 18.0]

45.5 [40.3, 50.8]

33.0 [26.2, 39.9]**

Key Secondary Endpoints

Clinical Remission, wk 4

Per CDAI^a

Per SF/APS^b

26.7 [20.2, 33.3]

14.8 [9.5, 20.0]

37.1 [32.1, 42.2]

35.7 [30.7, 40.7]

10.8 [2.9, 18.6]*

21.2 [14.3, 28.2]**

Corticosteroid-free clinical remission, wk 12

per CDAI^d

per SF/APS^d

(N=64)

15.7 [6.8, 24.7]

12.5 [4.4, 20.6]

(N=126)

42.9 [34.2, 51.5]

44.4 [35.8, 53.1]

27.7 [15.7, 39.8]**

32.6 [21.5, 43.7]**

Clinical Response CR-100^e

Week 2

Week 12

20.4 [14.4, 26.5]

37.3 [30.1, 44.5]

32.2 [27.3, 37.1]

56.6 [51.4, 61.8]

11.7 [4.2, 19.2]*

19.8 [11.3, 28.4]**

Endoscopic remission^f, wk 12

7.4 [3.5, 11.3]

28.9 [24.2, 33.7]

21.8 [15.8, 27.8]**

Patient randomization was stratified by baseline corticosteroid use, endoscopic disease severity, and the number of previously failed biologics. All patients within this dataset were included here within the ITT population.

a. Clinical remission per CDAI = per US, CDAI < 150

b. Clinical remission per SF/APS = per EU, average daily SF ≤ 2.8 and average daily APS ≤ 1.0 and both not greater than baseline

c. Endoscopic response = decrease in SES-CD > 50% from baseline (or for subjects with a baseline SES-CD of 4, at least a 2-point reduction from baseline), as scored by a central reviewer

d. Corticosteroid-free clinical remission = discontinuation of corticosteroid use and achievement of clinical remission per CDAI or SF/APS at wk 12 among patients on corticosteroids at baseline

e. Clinical response-100 = decrease of ≥ 100 points in CDAI from baseline

f. Endoscopic remission = SES-CD ≤ 4, at least a 2-point reduction versus baseline and no subscore >1 in any individual variable, as scored by a central reviewer

g. Results are based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C).

h. 95% CI for adjusted difference and p-value are calculated according to the Cochran-Mantel-Haenszel (CMH) test adjusted for randomization strata.

**P ≤ .0001 or *P ≤ .01 vs PBO; Average daily abdominal pain score, APS; Coronavirus disease 2019, COVID-19; Confidence Interval, CI; Crohn’s Disease Activity Index, CDAI; Simple Endoscopic Score for CD, SES-CD, Placebo, PBO; Once daily, QD; average daily very soft/liquid stool frequency, SF; Upadacitinib, UPA

Table: Table 1. Co-primary and Key Secondary Endpoints

Disclosures:

Edward Loftus: AbbVie – Consultant, Grant/Research Support. Amgen – Consultant, Grant/Research Support. Arena Pharmaceuticals – Consultant. Boehringer Ingelheim – Consultant. Bristol-Myers Squibb – Consultant, Grant/Research Support. Calibr – Consultant. Celgene – Consultant, Grant/Research Support. Eli Lilly – Consultant. Genentech – Consultant, Grant/Research Support. Gilead – Consultant, Grant/Research Support. Iterative Scopes – Consultant. Janssen – Consultant, Grant/Research Support. Morphic – Consultant. Ono Pharma – Consultant. Pfizer – Consultant, Grant/Research Support. Protagonist – Consultant. Receptos – Grant/Research Support. Robarts Clinical Trials – Grant/Research Support. Scipher Medicine – Consultant. Sun Pharma – Consultant. Surrozen – Consultant. Takeda – Consultant, Grant/Research Support. Theravance – Grant/Research Support. UCB – Consultant, Grant/Research Support.

Jean-Frederic Colombel: AbbVie – Consultant, Grant/Research Support. Amgen – Consultant. Arena – Consultant. BMS – Consultant. Boehringer Ingelheim – Consultant. Celgene Corporation – Consultant. Celltrion – Personal Fees. Eli Lilly – Consultant. Enterome – Personal Fees. Ferring Pharmaceuticals – Consultant. Galmed Research – Consultant. Galxo Smith Kline – Consultant. Genentech – Consultant. Genfit – Stock Options. Imedex – Consultant. Immunic – Consultant. Intestinal Biotech Development – Stock Options. Intestinal Biotech Development – Stock Options. Iterative Scopes – Consultant. Janssen Pharmaceuticals – Advisory Committee/Board Member, Consultant, Grant/Research Support. Kaleido Biosciences – Consultant. MedImmune – Personal Fees. Merck – Consultant. Microba – Consultant. Novartis – Consultant. PBM Capital – Consultant. Pfizer – Consultant. PPM Services – Personal Fees. Protagonist Therapeutics – Consultant. Sanofi – Consultant. Second Genome – Personal Fees. Seres – Personal Fees. Shire – Personal Fees. Takeda – Advisory Committee/Board Member, Consultant, Grant/Research Support. Theradiag – Personal Fees. TiGenix – Consultant. Vifor – Consultant.

Ana Paula Lacerda: AbbVie – Employee, Stock Options.

Laurent Peyrin-Biroulet: AbbVie – Grant/Research Support, Personal Fees. Allergan – Personal Fees. Alma Bio Therapeutics – Personal Fees. Amgen – Personal Fees. Arena – Personal Fees. Biogen – Personal Fees. Boehringer-Ingelheim – Personal Fees. Celgene – Personal Fees. Celltrion – Personal Fees. Clementia Pharmaceuticals – Stock Options. Enterome – Personal Fees. Ferring – Personal Fees. Genentech – Personal Fees. Gilead – Personal Fees. Hikma – Personal Fees. InDex Pharmaceuticals – Personal Fees. Janssen – Personal Fees. Merck/MSD – Grant/Research Support, Personal Fees. Nestle – Personal Fees. Pfizer – Personal Fees. Pharmacosmos – Personal Fees. Roche – Personal Fees. Samsung Bioepis – Personal Fees. Sandoz – Personal Fees. Sterna Biological – Personal Fees. Takeda – Grant/Research Support, Personal Fees. Tillots Pharma – Personal Fees.

Geert D’Haens: AbbVie – Advisor or Review Panel Member, Speakers Bureau. Ablynx – Advisor or Review Panel Member. Allergan – Advisor or Review Panel Member. Alphabiomics – Advisor or Review Panel Member. AM Pharma – Advisor or Review Panel Member. Amakem – Advisor or Review Panel Member. Amgen – Advisor or Review Panel Member. Arena Pharmaceuticals – Advisor or Review Panel Member. AstraZeneca – Advisor or Review Panel Member. Avaxia – Advisor or Review Panel Member. Biogen – Advisor or Review Panel Member, Speakers Bureau. Boehringer-Ingelheim – Advisor or Review Panel Member. Bristol-Myers Squibb(BMS) – Advisor or Review Panel Member. Celgene/Receptos – Advisor or Review Panel Member. Celltrion – Advisor or Review Panel Member. Cosmo – Advisor or Review Panel Member. Dr FALK Pharma – Advisor or Review Panel Member. Echo Pharmaceuticals – Advisor or Review Panel Member. Eli Lilly – Advisor or Review Panel Member. Engene – Advisor or Review Panel Member. Ferring – Advisor or Review Panel Member, Speakers Bureau. Galapagos – Advisor or Review Panel Member. Genentech/Roche – Advisor or Review Panel Member. Gilead – Advisor or Review Panel Member. GlaxoSmithKlein(GSK) – Advisor or Review Panel Member. Gossamerbio – Advisor or Review Panel Member. Hospira – Advisor or Review Panel Member. Immunic – Advisor or Review Panel Member. Johnson & Johnson – Advisor or Review Panel Member, Speakers Bureau. Kintai Therapeutics – Advisor or Review Panel Member. Lycera – Advisor or Review Panel Member. Medimetrics – Advisor or Review Panel Member. Medtronics – Advisor or Review Panel Member. Merck/MSD – Advisor or Review Panel Member, Speakers Bureau. Millenium/Takeda – Advisor or Review Panel Member, Speakers Bureau. Mitsubishi Pharma – Advisor or Review Panel Member. Mundipharma – Advisor or Review Panel Member, Speakers Bureau. Nextbiotics – Advisor or Review Panel Member. Norgine – Speakers Bureau. Novonordisk – Advisor or Review Panel Member. Otsuka – Advisor or Review Panel Member. Pfizer – Advisor or Review Panel Member, Speakers Bureau. Photopill – Advisor or Review Panel Member. Prodigest – Advisor or Review Panel Member. Progenity – Advisor or Review Panel Member. Prometheus laboratories/Nestle – Advisor or Review Panel Member. Protagonist – Advisor or Review Panel Member. RedHill – Advisor or Review Panel Member. Robarts Clinical Trials – Advisor or Review Panel Member. Salix – Advisor or Review Panel Member. Samsung Bioepis – Advisor or Review Panel Member, Speakers Bureau. Sandoz – Advisor or Review Panel Member. Seres/Nestle – Advisor or Review Panel Member. Setpoint – Advisor or Review Panel Member. Shire – Advisor or Review Panel Member, Speakers Bureau. Teva – Advisor or Review Panel Member. Tigenix – Advisor or Review Panel Member. Tillots Pharma – Advisor or Review Panel Member, Speakers Bureau. Topivert – Advisor or Review Panel Member. Versant – Advisor or Review Panel Member. Vifor Pharma – Advisor or Review Panel Member, Speakers Bureau.

Remo Panaccione: Abbott – Consultant. AbbVie – Advisory Committee/Board Member, Consultant, Grant/Research Support, Speakers Bureau. Alimentiv – Consultant. Amgen – Advisory Committee/Board Member, Consultant. Arena – Advisory Committee/Board Member, Consultant, Speakers Bureau. AstraZeneca – Consultant. Boehringer Ingelheim – Consultant. Bristol Myers Squibb – Advisory Committee/Board Member, Consultant. Celgene – Advisory Committee/Board Member, Consultant, Speakers Bureau. Celltrion – Advisory Committee/Board Member, Consultant. Cosmos Pharmaceuticals – Consultant. Eisai – Consultant. Elan – Consultant. Eli Lilly – Advisory Committee/Board Member, Consultant, Speakers Bureau. Ferring – Advisory Committee/Board Member, Consultant, Grant/Research Support, Speakers Bureau. Galapagos – Advisory Committee/Board Member, Consultant. Genentech – Advisory Committee/Board Member, Consultant. Gilead Sciences – Advisory Committee/Board Member, Consultant, Speakers Bureau. GlaxoSmithKline – Advisory Committee/Board Member, Consultant. Janssen – Advisory Committee/Board Member, Consultant, Grant/Research Support, Speakers Bureau. Merck – Advisory Committee/Board Member, Consultant, Speakers Bureau. Mylan – Advisory Committee/Board Member, Consultant. Oppilan Pharma – Advisory Committee/Board Member, Consultant. Pandion Pharma – Advisory Committee/Board Member. Pandion Therapeutics – Consultant. Pfizer – Advisory Committee/Board Member, Consultant, Grant/Research Support, Speakers Bureau. Progenity – Consultant. Protagonist Therapeutics – Consultant. Roche – Consultant, Speakers Bureau. Sandoz – Advisory Committee/Board Member, Consultant, Speakers Bureau. Satisfai Health – Consultant. Schering-Plough – Consultant. Shire – Advisory Committee/Board Member, Consultant, Speakers Bureau. Sublimity Therapeutics – Advisory Committee/Board Member, Consultant. Takeda – Advisory Committee/Board Member, Consultant, Grant/Research Support, Speakers Bureau. Theravance – Advisory Committee/Board Member, Consultant. UCB – Consultant.

Walter Reinisch: 4SC – Advisory Committee/Board Member, Consultant. Abbott Laboratories – Advisory Committee/Board Member, Consultant, Grant/Research Support, Speakers Bureau. AbbVie – Advisory Committee/Board Member, Consultant, Grant/Research Support, Speakers Bureau. Aesca – Advisory Committee/Board Member, Consultant, Grant/Research Support, Speakers Bureau. Algernon – Consultant. AM Pharma – Advisory Committee/Board Member, Consultant. Amgen – Advisory Committee/Board Member, Consultant. AMT – Consultant. AOP Orphan – Consultant. Aptalis – Speakers Bureau. Arena Pharmaceuticals – Consultant. Astellas – Advisory Committee/Board Member, Consultant, Speakers Bureau. AstraZeneca – Advisory Committee/Board Member, Consultant. Avaxia – Advisory Committee/Board Member, Consultant. Bioclinica – Consultant. Biogen IDEC – Advisory Committee/Board Member, Consultant. Boehringer Ingelheim – Advisory Committee/Board Member, Consultant. Bristol Myers Squibb – Advisory Committee/Board Member, Consultant. Celgene – Advisory Committee/Board Member, Consultant. Cellerix – Advisory Committee/Board Member, Consultant. Celltrion – Advisory Committee/Board Member, Consultant, Speakers Bureau. Centocor – Advisory Committee/Board Member, Consultant, Grant/Research Support, Speakers Bureau. ChemoCentryx – Advisory Committee/Board Member, Consultant. Covance – Consultant. Danone Austria – Advisory Committee/Board Member, Consultant, Speakers Bureau. DSM – Advisory Committee/Board Member, Consultant. Elan – Advisory Committee/Board Member, Consultant, Speakers Bureau. Eli Lilly – Consultant. Ernest & Young – Consultant. Falk Pharma GmbH – Consultant, Grant/Research Support, Speakers Bureau. Ferring – Advisory Committee/Board Member, Consultant, Speakers Bureau. Galapagos – Advisory Committee/Board Member, Consultant. Gatehouse Bio – Consultant. Genentech – Advisory Committee/Board Member, Consultant. Gilead – Consultant. Grünenthal – Advisory Committee/Board Member, Consultant. ICON – Consultant. Immundiagnostik – Grant/Research Support, Speaker. Index Pharma – Consultant. Inova – Advisory Committee/Board Member, Consultant. Intrinsic Imaging – Consultant. Janssen – Advisory Committee/Board Member, Consultant, Grant/Research Support. Johnson & Johnson – Advisory Committee/Board Member, Consultant. Kyowa Hakko Kirin Pharma – Advisory Committee/Board Member, Consultant. Lipid Therapeutics – Advisory Committee/Board Member, Consultant. LivaNova – Consultant. Mallinckrodt – Consultant. Medahead – Consultant. MedImmune – Advisory Committee/Board Member, Consultant. Millenium – Advisory Committee/Board Member, Consultant. Mitsubishi Tanabe Pharma Corporation – Advisory Committee/Board Member, Consultant, Speakers Bureau. MSD – Advisory Committee/Board Member, Consultant, Grant/Research Support, Speakers Bureau. Nash Pharmaceuticals – Consultant. Nestle – Advisory Committee/Board Member, Consultant. Nippon Kayaku – Consultant. Novartis – Advisory Committee/Board Member, Consultant. Ocera – Advisory Committee/Board Member, Consultant. OMass – Consultant. Otsuka – Advisory Committee/Board Member, Consultant, Speakers Bureau. Parexel – Consultant. PDL – Advisory Committee/Board Member, Consultant, Speakers Bureau. Periconsulting – Consultant. Pfizer – Advisory Committee/Board Member, Consultant. Pharmacosmos – Advisory Committee/Board Member, Consultant, Speakers Bureau. Philip Morris Institute – Consultant. PLS Education – Speakers Bureau. Procter & Gamble – Advisory Committee/Board Member, Consultant. Prometheus – Advisory Committee/Board Member, Consultant. Protagonist – Consultant. Provention – Consultant. Quell Therapeutics – Consultant. Robarts Clinical Trial – Consultant. Roland Berger GmbH – Consultant. Sandoz – Advisory Committee/Board Member, Consultant, Grant/Research Support. Schering-Plough – Advisory Committee/Board Member, Consultant, Speakers Bureau. Second Genome – Advisory Committee/Board Member, Consultant. Seres Therapeutics – Consultant. Setpoint Medical – Advisory Committee/Board Member, Consultant. Shire – Speakers Bureau. Sigmoid – Consultant. Sublimity – Consultant. Takeda – Advisory Committee/Board Member, Consultant, Grant/Research Support, Speakers Bureau. Therakos – Advisory Committee/Board Member, Consultant, Speakers Bureau. Theravance – Consultant. TiGenix – Advisory Committee/Board Member, Consultant. UCB – Advisory Committee/Board Member, Consultant. Vifor – Consultant, Speakers Bureau. Yakult – Speakers Bureau. Zealand – Advisory Committee/Board Member, Consultant. Zyngenia – Advisory Committee/Board Member, Consultant.

Edouard Louis: AbbVie – Advisory Committee/Board Member, Consultant, Grant/Research Support, Speakers Bureau. Arena Pharmaceuticals – Advisory Committee/Board Member. Celgene – Advisory Committee/Board Member. Falk – Speakers Bureau. Ferring – Advisory Committee/Board Member, Speakers Bureau. Galapagos – Advisory Committee/Board Member. Gilead – Advisory Committee/Board Member. Hospira – Advisory Committee/Board Member, Speakers Bureau. Janssen – Advisory Committee/Board Member, Grant/Research Support, Speakers Bureau. MSD – Advisory Committee/Board Member, Grant/Research Support, Speakers Bureau. Pfizer – Advisory Committee/Board Member, Grant/Research Support, Speakers Bureau. Takeda – Advisory Committee/Board Member, Grant/Research Support, Speakers Bureau.

Minhu Chen: AbbVie – Provided educational activities. Boehringer-Ingelheim – Advisory Committee/Board Member. China Medical System – Provided educational activities. IPSEN – Provided educational activities. Janssen – Advisory Committee/Board Member, Grant/Research Support. Takeda – Grant/Research Support, Provided educational activities.

Hiroshi Nakase: AbbVie – Consultant. Boehringer-Ingelheim – Grant/Research Support. Bristol-Myers Squibb(BMS) – Grant/Research Support. Celgene – Consultant. Daiichi Sankyo – Consultant. EA Pharma – Consultant. Hoya Group Pentax Medical – Grant/Research Support. Janssen – Consultant. JIMRO – Consultant. Kissei Pharmaceuticals – Consultant. Kyorin – Consultant. Mitsubishi Tanabe Pharma Corporation – Consultant. Mochida Pharmaceutical – Consultant. Nippon Kayaku – Consultant. Pfizer – Consultant. Takeda – Consultant. Zeria Pharmaceutical – Consultant.

Susan Greenbloom indicated no relevant financial relationships.

George DuVall indicated no relevant financial relationships.

Yuri Sanchez-Gonzalez: AbbVie – Employee, Stock Options.

Mohamed-Eslam Mohamed: AbbVie – Employee, Stock Options.

Susan Rhee: AbbVie – Employee, Stock Options.

Tian Feng: AbbVie – Employee, Stock Options.

Elena Dubcenco: AbbVie – Employee, Stock Options.

Julian Panés: AbbVie – Grant/Research Support, Personal fees. Arena – Personal fees. Athos – Personal fees. Boehringer Ingelheim – Personal fees. Celgene – Personal fees. Celltrion – Personal fees. Ferring Pharmaceuticals – Personal fees. Galapagos – Personal fees. Genentech/Roche – Personal fees. GSK – Personal fees. Immunic – Personal fees. Janssen Pharmaceuticals – Personal fees. Mirum – Personal fees. Morphic – Personal fees. Nestlé – Personal fees. Origo – Personal fees. Pandion – Personal fees. Pfizer Inc – Grant/Research Support, Personal fees. Progenity – Personal fees. Takeda – Personal fees. Theravance Biopharma – Personal fees. Wassermann – Personal fees.