A Double Blind, Placebo-Controlled, Randomized Study in Subjects With Acne Vulgaris

Primary Objective

- To assess the safety and tolerability of B244 relative to placebo in subjects with acne
vulgaris after 14 days treatment Secondary Objectives

- To evaluate the efficacy of B244 relative to placebo in subjects with acne vulgaris
after 14 days of treatment

Inclusion Criteria:

1. Male and female subjects ≥18 and ≤45 years of age

2. In good general health as determined by a thorough medical history and physical
examination, electrocardiogram (ECG), vital signs, and clinical laboratory
evaluation. Results of clinical laboratory tests must be without clinically
significant abnormalities, including hematology, clinical chemistry and urinalysis.

3. Clinical diagnosis of facial acne vulgaris defined as:

- ≥105 inflammatory lesions

- ≥10 non-inflammatory lesions

- IGA ≥32

4. Willing to refrain from using any treatments, other than the investigational product,
including antibiotics, for acne present on the face. Topical acne treatments that do
not have significant or measurable systemic absorption (e.g., benzoyl peroxide,
salicylic acid) are allowed for treatment of acne of the back, shoulders and chest
only.

5. Ability to comprehend and comply with procedures

6. Agree to commit to participate in the current protocol

7. Provide written informed consent prior to any study procedure being performed (all
subjects should be able to understand the informed consent form and any other
documents that subjects are required to read)

Exclusion Criteria:

1. Female subjects who are pregnant or lactating or who are trying to conceive

2. Female subjects with a positive urine β-human chorionic gonadotropin (β-hCG) test at
screening or positive β-hCG urine at pre-dose

3. Any clinically relevant abnormality identified on the screening history, physical or
laboratory examinations, or any other medical condition or circumstance making the
volunteer unsuitable for participation in the study

4. Any skin condition which may interfere with the evaluation of safety or of acne
vulgaris (e.g., rosacea; seborrheic dermatitis; perioral dermatitis;
corticosteroid-induced acne or folliculitis)

5. Use of tanning booths or excessive sun exposure, in the opinion of the investigator

6. Active cystic acne or acne congoblata, acne fulminans, and secondary acne

7. Two or more active nodular lesions

8. Treatment with over-the-counter topical medications for the treatment of acne
vulgaris including benzoyl peroxide, topical anti-inflammatory medications,
corticosteroids, α-hydroxy/glycolic acid on the face within 2 weeks prior to baseline

9. Treatment with systemic corticosteroids (including intranasal and inhaled
corticosteroids) within 4 weeks prior to baseline

10. Treatment with systemic antibiotics or systemic anti-acne drugs or systemic
anti-inflammatory drugs within 4 weeks prior to baseline

11. Prescription topical retinoid use on the face within 4 weeks of baseline (e.g.,
tretinoin, tazarotene, adapalene)

12. Treatment with hormonal therapy or dose change to hormonal therapy within 12 weeks
prior to baseline. Dose and frequency of use of any hormonal therapy started more
than 12 weeks prior to baseline must remain unchanged throughout the study. Hormonal
therapies include, but are not limited to, estrogenic and progestational agents such
as birth control pills.

13. Use of androgen receptor blockers (such as spironolactone or flutamide)

14. Oral retinoid use (e.g., isotretinoin) within 12 months prior to baseline or vitamin
A supplements greater than 10,000 units/day within 6 months of baseline

15. Facial procedures (chemical or laser peel, microdermabrasion, etc.) within the 8
weeks of the first dose or during the study

16. A positive urine drug screen for drugs of abuse, including alcohol or positive urine
cotinine (≥300 ng/mL for cotinine) at the screening visit or at entry to the clinic
(Note: urine cotinine required at screening visit only)

17. Treatment with any investigational drug within 30 days or 5 half-lives (whichever is
longer) prior to the beginning of the screening period (this includes investigational
formulations of marketed products, inhaled and topical drugs)

18. Hypersensitivity to B244 or its components

19. Blood collection of greater than 500 mL within 56 days prior to screening

20. Seropositive for human immunodeficiency virus (HIV) at screening

21. Positive for Hepatitis B virus surface antigen (HBsAg) or positive Hepatitis C virus
antibody (HCV Ab) at screening

22. Any other condition and/or situation that causes the Investigator to deem a subject
unsuitable for the study (e.g., due to expected study medication non-compliance,
inability to medically tolerate the study procedures, or a subject's unwillingness to
comply with study-related procedures)