Efficacy Study of Trichuris Suis Ova to Treat Chronic Plaque Psoriasis

This is an open-label study to assess the safety and efficacy of 16 weeks of treatment with
7500 trichuris suis ova (TSO 7500) given every 2 weeks (a total of 8 doses) for the
treatment of moderate-to-severe, chronic, plaque-type psoriasis.

Inclusion criteria:

1. Males or females, 18-75 years old

2. Diagnosis of stable plaque type psoriasis for at least 6 months prior to baseline

3. Baseline moderate to severe psoriasis, defined as:

1. Psoriasis covering a body surface area (BSA) ≥10%;

2. Physician's global assessment (PGA) ≥3, and;

3. PASI ≥12

4. Must be in good health as judged by the PI, based on medical history, physical
examination, and clinical laboratories

5. In the opinion of the PI, must be a candidate for systemic therapy or phototherapy of
psoriasis

6. If a woman, before entry she must be one of the following:

1. Postmenopausal, defined as 45 years of age with amenorrhea for at least 18
months, or >45 years of age with amenorrhea for >6 months and a serum follicle
stimulating hormone (FSH) level >40 IU/mL, or surgically postmenopausal
(bilateral oophorectomy)

2. surgically sterile (have had a hysterectomy or tubal ligation or otherwise be
incapable of pregnancy)

3. If heterosexually active, practicing a highly effective method of birth control,
including hormonal prescription oral contraceptives, contraceptive injections,
contraceptive patch, intrauterine device, double-barrier method (eg, condoms,
diaphragm, or cervical cap, with spermicidal foam, cream, or gel), or male
partner sterilization for the duration of their participation in the study and
for 2 months after receiving the last administration of any study agent; or

4. Not heterosexually active

7. Women of childbearing potential must have a negative pregnancy test (urine and serum)
prior to randomization

8. Agree to avoid prolonged exposure to natural sunlight or tanning beds or phototherapy
devices for the duration of the study

9. Agree to avoid any prohibited concomitant medications as detailed below for the
duration of the study and for 4 weeks prior to baseline

10. Negative stool culture

11. Subject has the ability to provide informed consent

12. Subjects who are on inhaled or ophthalmic steroids are allowed

Exclusion Criteria:

1. Subjects with known history of intestinal parasitic infection, even if adequately
treated, in the past 5 years

2. Subject received antibiotic, antifungal or antiparasitic medication in the last 2
weeks prior to Screening and/or would potentially require this during the study
treatment period

3. Subject with history of drug or alcohol abuse within 6 months prior to screening

4. Subject with evidence of poor compliance with medical advice and instruction
including diet or medication

5. Subject is unable or unwilling to swallow study medication suspension

6. Subject with a significant medical condition which puts the subject at risk for study
participation and/or for any reason is considered by the Investigator to be an
unsuitable candidate to receive TSO or is potentially put at risk by study procedures

7. Subjects who has participated in another clinical trial within 30 days of screening
for this trial and/or any experimental treatment for this population

8. White blood cell count ≤3,000/mm3 (≤3.0 x 109/L) or ≥14,000/mm3 (≥14 x 109/L)

9. Platelet count ≤ 100,000/μL (≤100 x 109/L)

10. Serum creatinine >2 x upper limit of normal (ULN)

11. Aspartate or alanine aminotransferase >2 x ULN

12. Total bilirubin >2 mg/dL (34 μmol/L)

13. Hemoglobin < 9 g/dL

14. Subjects who are currently taking or have taken in the past 30 days, for any reason,
any medication that, in the opinion of the investigator, suppressed the immune
response. This may include but is not limited to systemic steroids, azathioprine,
cyclosporine, tacrolimus, mycophenolate mofetil, mycophenolic acid, etanercept,
adalimumab, infliximab, ustekinumab, cimzia, or any other biologic agent targeted to
any cell or cytokine in the immune system.

15. Subjects who are refractory to 2 or more biological agent plaque psoriasis therapies
due to lack of efficacy

16. Subjects currently taking or who have taken in the past 2 weeks, topical steroids

17. Subjects on a non-stable dose of vitamin D analog in the past 30 days

18. Subjects currently taking or who have taken in the past 30 days any medications
likely to improve psoriasis and thus interfere with evaluation. This may include, in
addition to the medications listed above, phototherapy, methotrexate, hydroxyurea, or
acitretin

19. Subjects with a diagnosis of inflammatory bowel disease (ulcerative colitis or
Crohn's disease) or of irritable bowel syndrome

20. Subjects with HIV-1/HIV-2 antibody, hepatitis B surface antigen, hepatitis C antibody

21. Subject received non-steroidal anti-inflammatory drugs within 2 weeks before Baseline
visit for more than 3 consecutive days, except acetylsalicylic acid ≤350 mg/d which
is allowed

22. Women who are intending to become pregnant or who are breastfeeding or planning to
breastfeed