Slide 1


 FAS population included 406 subjects: 400 mg QD (n=101), 400 mg BID (n=102), 600 mg BID (n=101) and placebo (n=102). At week 24 , PASI-75 was 

achieved by 44.3%, 47.2% and 39.7% patients in PPC-06 600 mg BID, 400 mg BID and 400 mg QD  groups, respectively, compared to 20% in the placebo 

group (p=0.004, 0.002 and 0.004 for the PPC-06 600 mg BID, 400 mg BID and 400 mg QD groups, respectively) (Fig.1).

 Additionally, 44.4%, 41.4% and 35.7% of patients in the PPC-06 600 mg BID and 400 mg BID and 400 mg QD groups, respectively, achieved an IGA score 

of 0/1 at week 24, compared to 22% of patients in the placebo group (p=0.010, 0.021 and 0.044 for the PPC-06 600 mg BID, 400 mg BID and 400 mg QD 

groups, respectively (Fig.1).

 Multiple Imputation was done for the missing efficacy data. Diarrhea was the most common TEAE, reported in 7%, 18%, 23% and 5% of patients in the 

PPC-06 400 mg QD, 400 mg BID, 600 mg BID, and placebo groups, respectively. Most cases being mild to moderate in severity. Nausea, abdominal pain 

were reported in < 10% and flushing in 1-2% of PPC-06 population. 

 Two subjects developed CTCAE grade 3 lymphopenia with PPC-06, but recovered uneventfully on discontinuation of study drug. No new/unexpected 

adverse events were reported compared to what is known for DMF drugs. PPC-06 demonstrated significant efficacy compared to placebo over 24 weeks of 

treatment for three dose strengths. 

PPC-06 (Tepilamide Fumarate), a novel fumaric acid ester, is efficacious in treating plaque psoriasis: 

Results from a phase 2b randomized controlled trial

Mark Lebwohl, MD1, Leon Kircik, MD1,2, Kristian Reich, MD3, Sagar Munjal, MD, MS4, Srinivas Shenoy, MD4, Ulrich Mrowietz MD5

1Mount Sinai School of Medicine, New York, NY; 2Skin Sciences, PLLC, Louisville, KY , 3University Medical Center Hamburg-Eppendorf, 

and Skinflammation® Center Hamburg, Germany, 4Dr. Reddy’s Laboratories Inc., Princeton, NJ, 5University Medical Center Schleswig-

Holstein, Campus Kiel, Kiel, Germany

Introduction

 Dimethyl fumarate (DMF) is approved in Europe for the 

treatment of moderate to severe plaque psoriasis. 

Monomethyl fumarate (MMF) is the active moiety.

 PPC-06 is a novel extended release MMF donor being 

developed for treatment of moderate to severe plaque 

psoriasis.

Conclusions

 PPC-06 may have potential to serve as an important therapeutic option for psoriasis 

patients in US as there are few oral treatments currently available. 

Methods

Figure 1. Co-Primary outcomes at week 24

 This phase 2b randomized, double blind, placebo-controlled, 

dose, regimen finding efficacy and safety study was 

conducted at 76 US sites. 

 Enrolled patients had chronic plaque psoriasis, PASI 

(Psoriasis Area and Severity Index) ≥12, IGA score 

(Investigator’s Global Assessment) ≥3, and BSA (Body 

Surface Area) ≥10%. 426 subjects were randomized in a 

1:1:1:1 ratio into 4 dose arms:  400 mg QD, 400 mg BID, 600 

mg BID, and placebo.  

 The co-primary end points at week 24 were PASI-75 (≥75% 

reduction from baseline PASI) and an IGA score of 

‘clear’/‘almost clear’ (i.e., 0/1).

Financial Support: This study was funded and sponsored by the Dr. Reddy’s Laboratories group of companies, Princeton, NJ, 08540, USA. DRL Publication # 885                                                                                                                          

Results

*Statistical significance reported with placebo

0

10

20

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50

60

70

80

90

100

PASI 75 IGA (0/1)

Co-Primary outcomes

PPC-06 600mg BID, n=101 PPC-06 400mg BID, n=102 PPC-06 400mg QD, n=101 Placebo, n=102

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