June 8, 2020

Dompé to Present Phase II Clinical Data for Ladarixin in New-Onset Type 1 Diabetes (T1D) at the American Diabetes Association’s Scientific Sessions

  • Accepted abstract to include results from phase 2 proof of concept trial on the potential for CXCR1/2 inhibition to slow-down the progression of new-onset T1D
  • Trial objective was to investigate whether ladarixin, an orally available investigational small molecule drug, has sufficient activity to preserve β-cell function in new-onset T1D

MILAN and SAN MATEO, Calif., May 18, 2020. – Dompé Farmaceutici S.p.A and Dompé U.S. Inc., (collectively Dompé) announced today that the Company will present new data at the American Diabetes Association's 80th Scientific Sessions in Chicago, IL, June 12-16, 2020. The abstract will highlight clinical data from Dompé’s recently completed Phase II clinical trial (MEX0114) for its novel CXCR1/2 inhibitor, ladarixin, in new-onset T1D.1

[Oral Presentation: 249-OR]

A Randomized, Double-blind Phase 2 Trial of The CXCR1/2 Inhibitor Ladarixin In Adult Patients with New Onset Type 1 Diabetes

Presenter: Prof. Paolo Pozzilli, MD

Sunday, June 14, 2020 5:00 PM – 5:15 PM CDT

For media queries or to schedule an interview, please contact Randi Kahn or Stefano Amoroso/Guido Romeo (contact information below).

About Type 1 Diabetes (T1D)

T1D is a chronic autoimmune disease that, over time, results in an immune-mediated loss of functional pancreatic β-cell mass, leading to symptomatic diabetes and lifelong insulin dependence.2,3 Currently available treatment approaches focus on glycemic control and do not address the high unmet medical need of delaying disease progression by preserving β-cell function.4

CXCL-8, a pro-inflammatory chemokine also known as IL-8, is an important mediator in several immune and metabolic disorders, including T1D.5 Modulation or inhibition of CXCL-8 activity through blockade of its cellular receptors, CXCR1/2, may be considered a target for the development of innovative treatments aimed at slowing the progression of T1D.6

About MEX0114

MEX0114 was a phase 2, multicenter, randomized, double-blind, placebo-controlled study in adult patients with new-onset type 1 diabetes. The objective of this clinical trial was to investigate whether ladarixin, a non-competitive allosteric inhibitor of CXCR1/2, has sufficient activity to preserve β-cell function and slow-down the progression of new-onset T1D. T1D was considered “new-onset” if the patient had received their first insulin administration within the past 100 days of randomization into the trial.1

The primary endpoint was the 2-hour AUC of C-peptide response to the mixed meal tolerance test (a standard measure of endogenous insulin secretion in T1D7) after three cycles of oral ladarixin treatment administered over 12 weeks. The safety of ladarixin as well as prespecified secondary analyses for A1c and total daily insulin requirement were also evaluated.1

About Dompé
Dompé is a private, rapidly scaling global biopharmaceutical company founded in Milan, Italy, with a 130-year legacy of medical innovation. Today, Dompé employs more than 800 employees worldwide and maintains a U.S. commercial operations hub in the San Francisco Bay Area as well as an R&D presence in Boston.

Forward Looking Statements
This press release refers to certain information that may not coincide with expected future results. Dompé firmly believes in the soundness and reasonableness of the concepts expressed. However, some of the information is subject to a certain degree of indetermination in relation to its research and development activities and the necessary verifications to be performed by regulatory bodies. Therefore, as of today, Dompé cannot guarantee that the expected results will be consistent with the information provided above.

Contacts

For the United States:

Randi Kahn

randi.kahn@syneoshealth.com

631 697 8310

For Europe:

Stefano Amoroso

+39 340 2838136

Stefano.Amoroso@dompe.com

Guido Romeo

+39 349 4154010

Guido.romeo@dompe.com

References

  1. A Phase 2, Multicentre, Randomized, Double-blind, Placebo-controlled Study in Patients with New-onset Type 1 Diabetes. https://clinicaltrials.gov/ct2/show/NCT02814838?term=ladarixin& rank=1. Accessed 3.2.2020.
  2. Atkinson MA, Eisenbarth GS, Michels AW. Type 1 diabetes. The Lancet 2014, 383:69-82.
  3. Eisenbarth GS. Type I diabetes mellitus. A chronic autoimmune disease. N Engl J Med 1986;314:1360–1368.
  4. Mittermayer F, Caveney E, De Oliveira C, Fleming GA, Gourgiotis L, Puri M, Tai LJ, Turner JR. Addressing Unmet Medical Needs in Type 1 Diabetes: A Review of Drugs Under Development. Curr Diabetes Rev. 2017;13(3):300-314.
  5. Alnek K, Kisand K, Heilman K, Peet A, Varik K, Uibo R (2015) Increased Blood Levels of Growth Factors, Proinflammatory Cytokines, and Th17 Cytokines in Patients with Newly Diagnosed Type 1 Diabetes. PLoS ONE 10(12): e0142976.
  6. Linhartova PB, Kavrikova D, Tomandlova M et al. Differences in Interleukin-8 Plasma Levels between Diabetic Patients and Healthy Individuals Independently on Their Periodontal Status. Intl J Molec Sci. 2018; 19 (3214): 1-17.
  7. Leighton E, Sainsbury CA, Jones GC. A Practical Review of C-Peptide Testing in Diabetes. Diabetes Ther. 2017 Jun;8(3):475-487.

Dompé farmaceutici S.p.A. Single shareholder company / Share capital € 50.000.000,00
REA MI 289519 - A registered company in Milan, Italy / Tax code and VAT number IT00791570153