BioPharmX (BPMX) Developments We are developing
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Posted On: 03/29/2016 12:11:20 AM
BioPharmX (BPMX) Developments
We are developing BPX01, a hydrophilic, topical antibiotic for the treatment of acne. BPX01 is a novel formulation and utilizes a transepidermal delivery mechanism for minocycline that we believe has the potential to kill P. acnes bacteria without the systemic side effects of orally-administered antibiotics. BPX01 contains an active pharmaceutical ingredient that is well known, and is expected to also possess anti-inflammatory properties, which reduce swelling and redness. We have completed a 4-week animal toxicity study to support our first Phase 2a clinical study, and we are currently conducting a 13-week animal toxicity study to support the planned 12-week Phase 2b clinical study. An IND to initiate the first Phase 2a clinical trial of BPX01 was submitted to the FDA in January 2016, and we received a letter from the FDA in March 2016 stating that the study may proceed. We intend to immediately commence the Phase 2a clinical study. We are also preparing to conduct a bridging safety study using oral minocycline as the comparator and a Phase 2b dose-finding clinical study for BPX01. We intend to pursue regulatory approval under Section 505(b)(2) of the FDC Act, or Section 505(b)(2). We believe the Section 505(b)(2) regulatory pathway, which permits us to rely in part on the FDA’s prior findings of safety and/or efficacy for an approved drug product, may reduce the product development risk and could reduce the time and resources we spend during development of BPX01. We believe our design approach for transepidermal delivery may also be utilized with other APIs.
We are developing BPX01, a hydrophilic, topical antibiotic for the treatment of acne. BPX01 is a novel formulation and utilizes a transepidermal delivery mechanism for minocycline that we believe has the potential to kill P. acnes bacteria without the systemic side effects of orally-administered antibiotics. BPX01 contains an active pharmaceutical ingredient that is well known, and is expected to also possess anti-inflammatory properties, which reduce swelling and redness. We have completed a 4-week animal toxicity study to support our first Phase 2a clinical study, and we are currently conducting a 13-week animal toxicity study to support the planned 12-week Phase 2b clinical study. An IND to initiate the first Phase 2a clinical trial of BPX01 was submitted to the FDA in January 2016, and we received a letter from the FDA in March 2016 stating that the study may proceed. We intend to immediately commence the Phase 2a clinical study. We are also preparing to conduct a bridging safety study using oral minocycline as the comparator and a Phase 2b dose-finding clinical study for BPX01. We intend to pursue regulatory approval under Section 505(b)(2) of the FDC Act, or Section 505(b)(2). We believe the Section 505(b)(2) regulatory pathway, which permits us to rely in part on the FDA’s prior findings of safety and/or efficacy for an approved drug product, may reduce the product development risk and could reduce the time and resources we spend during development of BPX01. We believe our design approach for transepidermal delivery may also be utilized with other APIs.
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