Results:  
Rapid and Effective

In conclusion, 
BPX-01 2% minocycline 
topical gel resulted in rapid 
improvement and better 
outcomes than vehicle control 
in the treatment of moderate-
to-severe non-nodular 
inflammatory acne vulgaris.  
This treatment may provide an 
effective new option with a favorable 
safety profile and potential for high 
patient compliance.   

This work was sponsored by BioPharmX; all investigators were active participants in the trial.  BPX-01 is limited by federal or US law to investigational use only.

Introduction

A reduction of 25% in the number of inflammatory lesions is considered clinically 
important and is recognized by patients as an indicator of an effective treatment.  
Because this milestone was reached within two weeks of treatment with BPX -01, it has 
the potential to result in optimal treatment compliance and improved patient 
satisfaction.  The rapid rate of improvement (43% after four weeks) outpaced that 
observed in a separate clinical trial with oral minocycline for acne in which improvement 
exceeding 40% required 12 weeks of treatment,4 with much lower systemic exposure. 

Additionally, BPX-01 2% resulted in 58.5% reduction in lesions with consistent trends
toward improvement in IGA, PGI, and satisfaction scores. The medication was well
tolerated with good safety profile and was largely undetectable in blood plasma, hence
no systemic side effects are anticipated.

1Mount Sinai St Luke’s, New York NY; 2Del Rosso Dermatology Research Center, Las Vegas NV; 3ACRC Trials/Innovative Dermatology, Plano, TX; 4Image Dermatology, Montclair, NJ; 5Dermatology Consulting Services, High
Point, NC; 6International Clinical Research-Tennessee, Murfreesboro, TN; 7International Clinical Research, Sanford, FL; 8DS Research, Louisville, KY; 9Tennessee Clinical Research Center, Nashville, TN; 10Skin Research
Institute, Coral Gables, FL; 11Austin Institute for Clinical Research, Heatherwilde, TX; 12Progressive Clinical Research, San Antonio, TX; 13MedaPhase, Newnan, GA; 14Medical & Cosmetic Dermatology, Santa Monica, CA;
15Premier Clinical Research, Spokane, WA; 16BioPharmX, Menlo Park, CA

Methods
This phase 2b study was intended to describe the safety 
and efficacy of topical minocycline in the treatment of 
inflammatory acne vulgaris.

Acne affects up to 50 million Americans annually.1 It can be
caused by sebaceous gland hyperactivity, abnormal
keratinocyte desquamation, and bacteria-related local
inflammatory changes.2,3 Comedones and inflammatory
papules, pustules and nodules are sites of proliferation for
Propionibacterium acnes bacteria.

BPX-01
topical minocycline gel

The study 
medication:

BPX-01 is the first completely solubilized minocycline gel for
topical use. It is intended for the treatment of non-nodular,
moderate-to-severe inflammatory acne vulgaris in patients
nine years of age and older. Its preliminary safety and
efficacy profile have been demonstrated in extensive
preclinical testing and a phase 2a study:

Strong 
Efficacy

» Stabilizes & solubilizes minocycline
» Delivered directly to pilosebaceous unit
» Targeted penetration

Strong 
Safety Profile

» Low dose: 1% and 2% minocycline
» Minimizes side effects
» Low systemic exposure » Rapidly absorbing

» Non-staining
» Non-oily
» Non-fluorescing
» Very high patient 

satisfaction in clinical 
trials

Positive Patient Experience

Primary Endpoint Achieved:
Reduction in P. acnes colonies

Change from Baseline 
at 4 weeks

Mean (Log10) Percentage

BPX-01 Minocycline 
(n=17) -1.04 -90.9%

Vehicle (n=7) -0.46 -65.3%

» No drug-related adverse events 
» No detectable plasma minocycline
» No cutaneous toxicity 
» 100% patient satisfaction

R
E

S
U

LT
S

Favorable Secondary and Safety 
Endpoints

» Randomized, double-blind, vehicle-controlled, dose-ranging study 
in 226 patients with moderate-to-severe acne

» 12-week study evaluating 3 arms: BPX-01 1% , BPX-01 2%, 
vehicle

» Conducted at 15 U.S. sites
» Patients ages 9 to 40, IGA* of 3 or 4, 20-60 non-nodular 

inflammatory lesions

1. Bickers DR, Lim HW, Margolis D, Weinstock MA, Goodman C, Faulkner E, et al. The burden of 
skin diseases: 2004 a joint project of the American Academy of Dermatology Association and 
the Society for Investigative Dermatology.  J Am Acad Dermatol. 2006;55:490-500. 

2. Gollnick H, Cunliffe W, Berson D, Dreno B, Finlay A, Leyden JJ, et al. Management of acne: a 
report from a Global Alliance to Improve Outcomes in Acne. J Am Acad Dermatol. 2003;49(1 
Suppl):S1-37.

3. Weiss JS. Acne: evolving concepts of pathogenesis need to guide therapeutic
developments. J Drugs Dermatol. 2013; 12: s66.

4. Torok HM. Extended-release formulation of minocycline in the treatment of moderate-to-
severe acne vulgaris in patients over the age of 12 years. J Clin Aesthet Dermatol.
2013;6[7]:19–22.

Poster presented at the 2017 Fall Clinical Dermatology Conference®; Las Vegas, NV; October 12-15, 2017.  

Primary Endpoint:  Absolute 
mean change in number of 
inflammatory lesions from 
baseline at week 12EN

D
P

O
IN

T
S Secondary Endpoint:  Proportion 

of subjects with at least a two-grade 
reduction in IGA* to clear or almost 
clear (0 or 1) at week 12

S
T

U
D

Y
 

D
E

S
IG

N

» Minocycline plasma concentrations
» Safety – adverse events
» Cutaneous tolerance
» Patient satisfaction
» Non-inflammatory lesion reduction

* Investigator Global Assessment; based 
on scale of 0 (clear) to 4 (severe)

E
X

P
L

O
R

A
T

O
R

Y
/ 

S
A

F
E

T
Y

BPX-01 1% BPX-01 2% Vehicle
Subjects per arm 73 72 74

Absolute mean change in 
inflammatory lesions at 
week 12

- 15.5 - 15.4 - 11.2

p-value 0.0543 0.0352

Percent reduction in 
inflammatory lesions 54.4% 58.5% 43.8%

p-value 0.0765 0.0256 15%

» Primary endpoint: Absolute mean change in number of inflammatory 
lesions from baseline at week 12

» The above analysis reflects the intent to treat (ITT) population of 219

Rapid Rate of Improvement in BPX-01 2% Arm: Key Takeaways

» > 25% reduction in lesions at week 2 with both doses
» A 25% improvement is considered meaningful to patients
» Reaching a 25% improvement within 2 weeks may lead 

to patient compliance and satisfaction with treatment
» 43.3% reduction in lesions at week 4 with 2% dose 
» 58.5% reduction in lesions at week 12 with 2% dose Week 12

59%

Clear Trend in IGA Reduction for 2% Treatment Arm

BPX-01 1% BPX-01 2% Vehicle
Subjects per arm 73 72 74

Proportion with ≥ two-
grade reduction and
clear or almost clear 

20.5% 25.0% 17.6%

p-value (vs vehicle) >0.9999 0.5445

» Secondary Endpoint*:  25% of subjects in the 2% arm demonstrated at least a two-
grade reduction in IGA to clear or almost clear (0 or 1)

» 7.4% separation between 2% dose and vehicle informs sample size for confirmatory 
phase 3 trials

7.4%

Demonstrated Rapid Lesion Reduction

Reduction in Inflammatory Lesions

Safety Endpoint:  Systemic Exposure

» Treatment-related adverse 
events occurred in 0.4% of 
subjects

» Generally safe and well 
tolerated in this study

» No serious treatment-related 
adverse events

» No photosensitivity or post-
inflammation hyperpigmentation 
was reported 

» No staining and/or skin 
discoloration was reported

Would you consider using again?
Yes / No

86% of subjects would use BPX-01 2% again

BPX-01
1%

BPX-01
2% Vehicle

Baseline BLOQ BLOQ BLOQ

Week 4 BLOQ BLOQ BLOQ

Week 12 BLOQ BLOQ* BLOQ

*One subject measured 42 ng/ml at 12 weeks; no AEs
BLOQ=Below Limit of Quantification (10 ng/mL)

» Minocycline was undetectable in the 
plasma of 99.5% of subjects.

» Further support for no anticipated 
systemic side effects

» Highly sensitive assay with LLoQ for 
minocycline of 10 ng/mL in plasma

Yes

NoPositive Patient Experience:
BPX-01 2% Shows Potential 
for High Patient Compliance

P
e

rc
e

n
ta

g
e

 R
e

d
u

ct
io

n
 v

s.
 B

a
se

li
n

e

* Study was not powered for this endpoint

Week 2

>25%

Week 4

43%

Onset of Benefit:  BPX-01 vs. Oral Minocycline ER

0.0%

-43.3%
-49.5%

-58.5%
-70%

-60%

-50%

-40%

-30%

-20%

-10%

0%

Baseline Week 4 Week 8 Week 12

BPX-01 2%

0.0%

-31.6%

-39.9%

-44.5%

-70%

-60%

-50%

-40%

-30%

-20%

-10%

0%

Baseline Week 4 Week 8 Week 12

Oral Minocycline ER
*See Reference #4 below. The 
results of two phase 3 studies 
were combined for comparison.

P
e

rc
e

n
ta

g
e

 L
e

si
o

n
 R

e
d

u
ct

io
n

vs
. 

B
a

se
li

n
e

» Not conducted as a head-to-head trial.  While recognizing that these trial data cannot be directly 
compared, BPX-01 may demonstrate a more rapid rate of improvement when compared to clinical 
data available for oral ER minocycline.*

» BPX-01 may demonstrate a greater percentage of reduction in inflammatory lesions at all time points. 

79%
1 2

3

4

5 
(most 

favorable)

Ease of use and application
Scale of 1-5

79% of subjects thought BPX-01 2% was easy to 
use and apply

Andrew Alexis,1 James Del Rosso,2 Seemal R. Desai,3 Jeanine Downie,4 Zoe Diana Draelos,5
Christina Feser,6 Rion Forconi,7 Joseph Fowler,8 Michael Gold,9 Joely Kaufman-Janette,10 Edward 
Lain,11 Mark Lee,12 Mark Ling,13 Ava Shamban,14 William Werschler,15 AnnaMarie Daniels16

Rapid Improvement with BPX-01 Minocycline Topical Gel in the 
Treatment of Moderate-to-Severe Inflammatory Acne Vulgaris: 
a Randomized, Double-Blind, Vehicle-Controlled Study

-70%

-60%

-50%

-40%

-30%

-20%

-10%

0%

Baseline Week 4 Week 8 Week 12

BPX-01 1% BPX-01 2% Vehicle
Baseline 0.0% 0.0% 0.0%
Week 2 -32.8% -27.6% -25.7%
Week 4 -39.7% -43.3% -25.3%
Week 8 -50.5% -49.5% -38.7%
Week 12 -54.4% -58.5% -43.8%

Adverse Events

Baseline Week 2 Week 4 Week 8 Week 12

25% 
Reduction


	FC17PosterBioPharmXRapidImprovementAlexis.pdf