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Homesarcomed2020-07-21T20:28:27+00:00


THE PATH TO BETTER HEALTH

Sarcoidosis and other Interstitial Lung Diseases



Contact Us




OUR MISSION


SarcoMed USA was formed in 2017 to investigate if a novel DNase 1 compound
(SM001) could influence the chronic pulmonary inflammation seen in Pulmonary
Sarcoidosis patients.

Sarcoidosis is a systemic granulomatous disease characterized by a T-helper-1
response with accumulation of CD4+ lymphocytes and activated macrophages in the
lungs and affected organs, resulting in characteristic granuloma formation. The
lungs are involved in more than 90% of patients with sarcoidosis, thus abnormal
pulmonary function is characteristic for many patients. Sarcoidosis affects
approximately 200,000 people in the United States and at present corticosteroids
are the only approved treatments.



A REDUCTION IN THE USE OF STEROIDS IS A SIGNIFICANT UNMET NEED FOR SARCOIDOSIS
PATIENTS




OUR SCIENCE

The presence of microbial DNA (mDNA) from mycobacteria, propionibacteria and
borrelia have been identified in sarcoidosis tissues suggesting their role in
sarcoidosis granuloma formation

 * Bacterial amyloid curli act as a carrier for such DNA to elicit an autoimmune
   response
 * Serum amyloid A (SAA) derived from the host may participate in the granuloma
   formation by regulating inflammation through Toll-like receptor-2 (TLR2)
 * SAA localized to macrophages and giant cells within sarcoidosis granulomas
   correlate with CD3(+) lymphocytes, linking expression to local Th1 responses
 * Additional antigens implicated in initiating the inflammatory cascade leading
   to granuloma formation include beta-actin, intermediate filament vimentin and
   pathogen-associated molecular patterns (PAMPs)

The DNase activity of SM001 is expected to degrade the microbial DNA within the
protein/DNA complex present in lungs of patients with pulmonary sarcoidosis
(extracellular red X marks). The reduction of the burden of bacterial DNA could
then reduce or eliminate the antigenic stimulation responsible for the
persistent immunological stimulation causing granuloma formation (See
intracellular orange X marks).





DEVELOPMENT

Lead product candidate, SM001, is a recombinant form of human deoxyribonuclease
I (DNase I), with a proven mechanism of action and a differentiated clinical
profile.

Regulatory Pathway
Clear development and regulatory pathway along with FDA Orphan status
designation granted for the treatment of sarcoidosis.

Clinical Development
Phase 1 healthy subject clinical study completed (SAD, MAD with 18 subjects).
SarcoMed is planning to initiate a Phase 1b Randomized, Double-Blind,
Placebo-Controlled Multiple Ascending Dose Study of Inhalation SM001 in Patients
with Pulmonary Sarcoidosis.




CONTACT US

Please contact us should you have an interest in learning more about our
efforts.
















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