BPMX commences Phase II clinical study under U.S. FDA IND for BPX-01BPMX
By Zacks Small Cap Research - Grant Zeng, CFA
BioPharmX (BPMX) is developing BPX01, a non-lipophilic, topical antibiotic for the treatment of acne. BPX01 utilizes a transepidermal delivery mechanism for minocycline and other APIs that has the potential to kill p. acnes bacteria without the systemic side effects of orally-administered antibiotics.
In March 2015, BioPharmX completed its planned pre-IND (Investigational New Drug) meeting with the US FDA which was focused on the company's proposed strategy for advancing BPX01and plans for conducting safety and toxicology studies, along with human clinical trials. Following the conclusion of the meeting, the company believes that it has sufficient guidance from the FDA for advancing toward an IND application for phase II clinical trials.
On March 3, 2016, BioPharmX announced that it will immediately commence a Phase IIa clinical study under its U.S. FDA IND application for BPX-01. This clinical study will assess effectiveness in reducing the number of acne-causing bacteria in study patients at four weeks and evaluate the drug's safety and tolerability. This is the first clinical study in the clinical development program for BPX-01.
The Phase IIa clinical study will be conducted by KGL Skin Center, a Philadelphia-based independent clinical research facility recognized as a leader in clinical testing of cosmetics, personal care products, over-the-counter and prescription drugs, and devices for the skin. The principal investigator is Dr. Stuart Lessin, a board-certified dermatologist who serves as KGL's medical director.
The company's preclinical studies have found the unique gel formulation of minocycline in BPX-01 can deliver the antibiotic to the layer of skin where the condition develops, suggesting that the skin penetration needed to reach an efficacious dose in humans while minimizing systemic exposure is possible.
BPMX intends to pursue regulatory approval of BPX01 under Section 505(b)(2) of the FDC Act. The 505(b)(2) regulatory pathway may reduce the drug development risks and costs by using prior findings of safety and/or efficacy for an approved product. In BPX01 case, part of the safety and efficacy data from the oral formulation of minocycline may be used for the filing of a NDA for BPX01.
If everything goes well, we estimate BPX01 will be approved by the FDA in calendar 2019. Peak sales of BPX01 should be around $450 million.
Background on Minocycline
Minocycline is a broad-spectrum tetracycline antibiotic, and has a broader spectrum than the other members of the group. It is a bacteriostatic antibiotic, classified as a long-acting type. As a result of its long half-life it generally has serum levels 2–4 times that of the simple water-soluble tetracyclines.
Minocycline is the most lipid-soluble of the tetracycline-class antibiotics, giving it the greatest penetration into the prostate and brain, but also the greatest amount of central nervous system (CNS)-related side effects, such as vertigo. A common side effect is diarrhea. Uncommon side effects (with prolonged therapy) include skin discoloration and autoimmune disorders that are not seen with other drugs in the class.
.
Minocycline and doxycycline are the two most frequently used oral antibiotics for the treatment of acne vulgaris. Both of these closely related antibiotics have similar levels of efficacy, although doxycycline has a slightly lower risk of adverse side effects.
The most common side effects of minocycline include upset stomach, diarrhea, dizziness, unsteadiness, drowsiness, mouth sores, headache and vomiting. Occasionally minocycline therapy may result in autoimmune disorders such as drug related lupus and auto-immune hepatitis. Minocycline can cause vestibular disturbances with dizziness, ataxia, vertigo and tinnitus. These effects are again thought to be related to minocycline's greater penetration into the central nervous system. Vestibular side effects are much more common in women than in men, occurring in 50% to 70% of women receiving minocycline. As a result of the frequency of this bothersome side effect, minocycline is rarely used in female patients.
BPX01’s Advantages over Oral Minocycline
All the side effects discussed above limit the use of oral minocycline for the treatment of acne. As a result, BioPharmX formulated BPX01 as a topical cream using a proprietary drug delivery technology. BPX01 is a new anhydrous, non-oil based topical antibiotic targeting acne bacteria.
BPX01 is designed to have several advantages compared to both orally-administered and other topically-administered retinoid- and antibiotic-based solutions. Advantages of BPX01 include:
topical delivery of minocycline,
controlled dosages targeted directly to affected area,
increased delivery of API at low dosages,
non-lipophilic design allowing for faster absorption by the skin,
potential lower risk of systemic side effects common to orally administered antibiotics,
Gel-like form rubs on like a sanitizer.
In addition, BPX01 has been shown in pre-clinical studies to possess anti-inflammatory properties, which reduce swelling and slow hyper-cornification.
By Zacks Small Cap Research - Grant Zeng, CFA
BioPharmX (BPMX) is developing BPX01, a non-lipophilic, topical antibiotic for the treatment of acne. BPX01 utilizes a transepidermal delivery mechanism for minocycline and other APIs that has the potential to kill p. acnes bacteria without the systemic side effects of orally-administered antibiotics.
In March 2015, BioPharmX completed its planned pre-IND (Investigational New Drug) meeting with the US FDA which was focused on the company's proposed strategy for advancing BPX01and plans for conducting safety and toxicology studies, along with human clinical trials. Following the conclusion of the meeting, the company believes that it has sufficient guidance from the FDA for advancing toward an IND application for phase II clinical trials.
On March 3, 2016, BioPharmX announced that it will immediately commence a Phase IIa clinical study under its U.S. FDA IND application for BPX-01. This clinical study will assess effectiveness in reducing the number of acne-causing bacteria in study patients at four weeks and evaluate the drug's safety and tolerability. This is the first clinical study in the clinical development program for BPX-01.
The Phase IIa clinical study will be conducted by KGL Skin Center, a Philadelphia-based independent clinical research facility recognized as a leader in clinical testing of cosmetics, personal care products, over-the-counter and prescription drugs, and devices for the skin. The principal investigator is Dr. Stuart Lessin, a board-certified dermatologist who serves as KGL's medical director.
The company's preclinical studies have found the unique gel formulation of minocycline in BPX-01 can deliver the antibiotic to the layer of skin where the condition develops, suggesting that the skin penetration needed to reach an efficacious dose in humans while minimizing systemic exposure is possible.
BPMX intends to pursue regulatory approval of BPX01 under Section 505(b)(2) of the FDC Act. The 505(b)(2) regulatory pathway may reduce the drug development risks and costs by using prior findings of safety and/or efficacy for an approved product. In BPX01 case, part of the safety and efficacy data from the oral formulation of minocycline may be used for the filing of a NDA for BPX01.
If everything goes well, we estimate BPX01 will be approved by the FDA in calendar 2019. Peak sales of BPX01 should be around $450 million.
Background on Minocycline
Minocycline is a broad-spectrum tetracycline antibiotic, and has a broader spectrum than the other members of the group. It is a bacteriostatic antibiotic, classified as a long-acting type. As a result of its long half-life it generally has serum levels 2–4 times that of the simple water-soluble tetracyclines.
Minocycline is the most lipid-soluble of the tetracycline-class antibiotics, giving it the greatest penetration into the prostate and brain, but also the greatest amount of central nervous system (CNS)-related side effects, such as vertigo. A common side effect is diarrhea. Uncommon side effects (with prolonged therapy) include skin discoloration and autoimmune disorders that are not seen with other drugs in the class.
.
Minocycline and doxycycline are the two most frequently used oral antibiotics for the treatment of acne vulgaris. Both of these closely related antibiotics have similar levels of efficacy, although doxycycline has a slightly lower risk of adverse side effects.
The most common side effects of minocycline include upset stomach, diarrhea, dizziness, unsteadiness, drowsiness, mouth sores, headache and vomiting. Occasionally minocycline therapy may result in autoimmune disorders such as drug related lupus and auto-immune hepatitis. Minocycline can cause vestibular disturbances with dizziness, ataxia, vertigo and tinnitus. These effects are again thought to be related to minocycline's greater penetration into the central nervous system. Vestibular side effects are much more common in women than in men, occurring in 50% to 70% of women receiving minocycline. As a result of the frequency of this bothersome side effect, minocycline is rarely used in female patients.
BPX01’s Advantages over Oral Minocycline
All the side effects discussed above limit the use of oral minocycline for the treatment of acne. As a result, BioPharmX formulated BPX01 as a topical cream using a proprietary drug delivery technology. BPX01 is a new anhydrous, non-oil based topical antibiotic targeting acne bacteria.
BPX01 is designed to have several advantages compared to both orally-administered and other topically-administered retinoid- and antibiotic-based solutions. Advantages of BPX01 include:
topical delivery of minocycline,
controlled dosages targeted directly to affected area,
increased delivery of API at low dosages,
non-lipophilic design allowing for faster absorption by the skin,
potential lower risk of systemic side effects common to orally administered antibiotics,
Gel-like form rubs on like a sanitizer.
In addition, BPX01 has been shown in pre-clinical studies to possess anti-inflammatory properties, which reduce swelling and slow hyper-cornification.
