Assessment of ANK-700 in Patients With Relapsing Remitting Multiple Sclerosis
Assessment of ANK-700 in Patients With Relapsing Remitting Multiple Sclerosis
A safety study of ANK-700 in patients with relapsing remitting multiple sclerosis. The study
 has two parts:

 Part A - first in human study in which patients receive a single dose of ANK-700 Part B -
 patients will receive three doses of either ANK-700 or placebo
Study ANK-700-01 is a Phase 1, FIH study designed to evaluate the safety and tolerability of
 ANK-700 in patients with relapsing remitting multiple sclerosis (rrms).

 An overview of the two parts and proposed dose groups is given below:

 Part A (SAD): Patients will receive a single dose of ANK-700. Part B (MAD): Patients will
 receive three doses of either ANK-700 or placebo.
Inclusion Criteria:

 -  Diagnosed with RRMS per revised McDonald criteria (2017) with an EDSS score ≤ 6.5 at
 screening

 -  Neurologically stable with no evidence of relapse within the 28 days before signing
 the informed consent form (ICF)

 -  Either not currently receiving disease modifying MS therapy, or currently using
 fumarate drugs (dimethyl fumarate or diroximel fumarate)

 -  Patients must use a highly effective method of birth control or are sterile or
 postmenopausal as confirmed by study Investigator

 -  Patient has signed and understands the ICF

 Exclusion Criteria:

 -  Diagnosis of primary progressive MS or secondary progressive MS

 -  Uncontrolled or significant medical conditions (including active infection or chronic
 hepatitis) which, in the opinion of the Investigator, preclude participation

 -  Patients treated with glatiramer acetate, parenteral steroids or adrenocorticotropic
 hormone, β-interferon, plasma exchange, fingolimod, ozanimod, or siponimod within the
 3 months prior to first dose

 -  Patients treated with cytotoxic agents (including, but not limited to, cladribine,
 mitoxantrone, cyclophosphamide, azathioprine, and methotrexate), laquinimod,
 teriflunomide, or IV gamma globulin within 12 months prior to first dose

 -  Patients treated with monoclonal antibody therapy (including natalizumab, daclizumab,
 rituximab, ofatumumab, and ocrelizumab) within 24 months prior to first dose

 -  Patients previously treated with alemtuzumab, total lymphoid irradiation, mesenchymal
 stem cell or hematopoietic stem cell transplantation, or tolerance-inducing therapies
 for MS

 -  Contraindication to or inability to undergo gadolinium-enhanced magnetic resonance
 imaging (MRI) scan

 -  Use of any investigational drug or experimental procedure within previous 6 months
 that would interfere with the assessment of ANK-700

 -  Patients who are pregnant or breastfeeding