Development and Assessment of BPX-01, a Novel Topical Minocycline Gel for Treatment of Acne Vulgaris


MedicalResearch.com Interview with:
Usha Nagavarapu, PhD

Senior director of preclinical drug development
BioPharmX

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Acne vulgaris is a complex chronic inflammatory disease known to be linked with P. acnes and can have profound social and psychological effects. Though a number of treatments exist, there is promise of a long-term benefit for acne patients. BioPharmX’s in vitro and in vivo studies have revealed that a low-dose, topical 1% minocycline gel (BPX-01) provided a localized and targeted delivery of adequate minocycline to the epidermis and pilosebaceous units that can potentially limit systemic exposure and may reduce treatment related side effects.

At the intended clinical dose, toxicity and safety animal studies found that BPX-01 was well tolerated with no significant local or systemic toxic effects. A comparative animal study with oral minocycline demonstrated that topical application of minocycline can limit systemic exposure while delivering sufficient minocycline to the skin to treat acne vulgaris.

Along the same lines, a 4-week clinical study with extended release oral minocycline to assess the skin and plasma concentrations of minocycline was conducted. A marked reduction of mean acne lesion counts from baseline was seen with oral minocycline with presence in plasma. On the contrary no minocycline was identified in the skin from periauricular biopsies.

Recently, BioPharmX completed a 4-week Phase 2 clinical repeat-dose study of BPX-01. The minocycline gel was well tolerated and over 90% of P. acnes were eliminated.

A 12-week Phase 2 dose-finding clinical trial to further assess the efficacy and safety of BPX-01 for the treatment of moderate-to-severe, non-nodular inflammatory acne vulgaris has been initiated. The dose-finding study will provide additional support for the planned Phase 3 clinical trial program with BPX-01.

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Taltz Demonstrates Improved Clearing of Psoriasis Compared to Stelara

MedicalResearch.com Interview with:

Prof. Dr. Kristian Reich, Dermatologikum Hamburg, Hamburg 07.04.2009 | Prof. Dr. Kristian Reich, Dermatologikum Hamburg, Hamburg, Germany, 07.04.2009 | [© (c) Martin Zitzlaff, Emilienstr.78, 20259 Hamburg, Germany, Tel. +491711940261, http://www.zitzlaff.com, martin@zitzlaff.com, Postbank Hamburg BLZ 20010020 Kto.-Nr. 10204204, MwSt. 7%, Veroeffentlichung nur gegen Honorar (MFM) und Belegexemplar, mit Namensnennung]

Prof. Reich

Prof. Dr. med. Kristian Reich
Dermatologie, Allergologie
Psoriasis- und Neurodermitis-Trainer
Hamburg

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The IXORA-S study compared the efficacy and safety of Taltz® (ixekizumab) and Stelara®* (ustekinumab) for the treatment of moderate-to-severe plaque psoriasis at 24 weeks.

In this study, patients were randomized to receive either Stelara (45 mg or 90 mg weight-based dosing per label) or Taltz (80 mg every two weeks followed by 80 mg every four weeks), following an initial starting dose of 160 mg. At 24 weeks, patients treated with Taltz achieved significantly higher response rates compared to patients treated with Stelara, including 83 percent of patients who achieved Psoriasis Area Severity Index (PASI) 90—the study’s primary endpoint—compared to 59 percent of patients who achieved PASI 90 after treatment with Stelara.

Results at 24 weeks also found:
• 91.2 percent of patients treated with Taltz achieved PASI 75 compared to 81.9 percent of patients treated with Stelara (p=0.015)
• 49.3 percent of patients treated with Taltz achieved PASI 100 compared to 23.5 percent of patients treated with Stelara (p=0.001)
• 86.6 percent of patients treated with Taltz achieve static Physician’s Global Assessment score (sPGA) 0 or 1 compared to 69.3 percent of patients treated with Stelara (p<0.001)

The majority of treatment-emergent adverse events were mild or moderate. There were no statistically significant differences between treatment groups in overall treatment-emergent adverse events. The safety profile for Taltz was consistent with previous clinical trials.

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Psoriasis: Efficacy and Safety of Guselkumab vs Humira for Moderate to Severe Disease

MedicalResearch.com Interview with:

Andrew Blauvelt, M.D., M.B.A. President and Investigator Oregon Medical Research Center

Dr. Blauvelt

Andrew Blauvelt, M.D., M.B.A.
President and Investigator
Oregon Medical Research Center

 MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Findings from the Phase 3 VOYAGE 1 study showed that patients with moderate to severe plaque psoriasis receiving guselkumab, an human anti-interleukin (IL)-23 monoclonal antibody, achieved significant improvement in skin clearance and in comparison with Humira® (adalimumab), a TNF blocker.  The Phase 3 study and head-to-head analysis of guselkumab vs. adalimumab showed the significant and durable efficacy of guselkumab as maintained through one year when compared with adalimumab, and the robust efficacy of this novel IL-23 targeted therapy in meeting all primary and major secondary endpoints.

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