A Study of Oral Ladarixin in Recent Onset Type 1 Diabetes and a Low Residual β-cell Function

Inclusion Criteria:

1. Male and female patients aged 14-45 years, inclusive;

2. Recent onset T1D (1st IMP dose within 180 days from 1st insulin administration);

3. Positive for at least one diabetes-related auto-antibody (anti-GAD; IAA, if obtainedwithin 10 days of the onset of insulin therapy; IA-2 antibody; ZnT8);

4. Require, or has required at some time, insulin therapy through one or more separatesubcutaneous injections or Continuous Subcutaneous Insulin Infusion (CSII).

5. Fasting C peptide < 0.205nmol/L;

6. Residual beta-cell function as per peak stimulated (MMTT) C-peptide level >0.2nmol/L; MMTT should not be performed within one week of resolution of a diabeticketoacidosis event;

7. Patient able to comply with all protocol procedures for the duration of the study,including scheduled follow-up visits and examinations;

8. Patients who have given written informed consent prior of any study-relatedprocedure not part of standard medical care (participants under the age of 18, shallprovide an assent for the study as per country requirements). Specific consent mustbe given by adolescents to be selected for the full PK analysis.

Exclusion Criteria:

1. A type 2 diabetes diagnosis or any other unstable chronic disease for which doseadjustment of specific medication is anticipated during the trial;

2. Moderate to severe renal impairment as per estimated Glomerular Filtration Rate (eGFR) 60 mL/min/1.73m2, as determined using Chronic Kidney Disease EpidemiologyCollaboration (CKD-EPI) creatinine equation;

3. Hepatic dysfunction defined by increased ALT/AST > 3 x upper limit of normal (ULN)and increased total bilirubin > 3 mg/dL [>51.3 μmol/L];

4. Hypoalbuminemia defined as serum albumin < 3 g/dL;

5. QTcF > 470 msec;

6. Occurrence of an episode of ketoacidosis or hypoglycemic coma in the past 2 weeks;

7. A history of significant cardiovascular disease/abnormality;

8. Known hypersensitivity to non-steroidal anti-inflammatory drugs;

9. Concomitant treatment with drugs metabolized by CYP2C9 with a narrow therapeuticindex [i.e. phenytoin, warfarin, sulphonylurea hypoglycemics (e.g. tolbutamide,glipizide, glibenclamide/glyburide, glimepiride, nateglinide) and high doseamitriptyline (> 50 mg/day)];

10. Previous (past 2 weeks) and concomitant treatment with antidiabetic agents asmetformin, sulfonylureas, glinides, thiazolidinediones, exenatide, liraglutide,DPP-IV inhibitors, SGLT2-inhibitors or amylin, or any medications known to influenceglucose tolerance (e.g. beta-blockers, angiotensin-converting enzyme inhibitors,interferons, quinidine antimalarial drugs, lithium, niacin, etc.);

11. Past (past month) or current administration of any immunosuppressive medications (including oral or systemic corticosteroids) and use of any investigational agents,including any agents that impact the immune response or the cytokine system;

12. Significant systemic infection during the 4 weeks before the 1st dose of the studydrug (e.g., infection requiring hospitalization, major surgery, or IV antibiotics toresolve; other infections, e.g., bronchitis, sinusitis, localized cellulitis,candidiasis, or urinary tract infections, must be assessed on a case-by-case basisby the investigator regarding whether they are serious enough to warrant exclusion);

13. History of positive status for hepatitis A (IgM), hepatitis B (not due toimmunization), hepatitis C and HIV..

14. Pregnant or breast-feeding women. Unwillingness to use effective contraceptivemeasures up to 2 months after the end of study drug administration (females andmales). Effective contraceptive measures include a hormonal birth control (e.g. oralpills, long term injections, vaginal ring, patch); the intrauterine device (IUD); adouble barrier method (e.g. condom or diaphragm plus spermicide foam); abstinence.