BioPharmX (NYSE: BPMX) Corporation is a specialty pharmaceutical firm that centers on the development of inventive dermatology products. Today, the company, which is “up 60% premarket on robust volume,” revealed positive findings from its Phase 2b clinical investigation of BPX-04 (a 1% minocycline gel).
BPX-04 fruitfully met the principal and trivial thresholds of the analysis by exhibiting a mean change that was statistically significant making it one of the top premarket movers today.
BioPharmX CEO, Dr. David S. Tierney, expressed the sheer delight derived from the positive outcome in addition to the confirmation of the security and cutaneous admissibility of the minocycline gel composition. The enterprise perceives these outcomes as additional affirmations of the advantages of its HyantX delivery system.
Dr. Mark Amster, an authorized investigator and dermatologist, remarked on the data and conveyed his sentiments by noting that his patients were “extremely pleased” with their involvement in this medical assessment. Besides that, he pointed out that the topline results hint BPX-04’s striking efficacy.
Moreover, his most riveting take away from his encounter was the satisfaction that the patients attained with reference to the well-designed gel formulation.
They further asserted that this BioPharmX’s outstanding product did not have an irritation effect that a majority of topical agents face. The practitioner is optimistic in the enhancement of this form of intervention that shows momentous potential.
Research Approach and Results
The analysis was randomized, double-blinded, and vehicle-controlled. It encompassed the Phase 2b experiment that engaged 207 subjects. Their age bracket was 18 years and above with moderate to extreme papulopustular rosacea across 11 locations in the United States.
The inquiry assessed the efficacy and safety of the application of BPX-04 once a day against a vehicle control across a treatment time-frame of 12 weeks.
In terms of permissibility and security, BPX-04 seemed to be greatly tolerated overall. The most frequently documented unfavorable incidents in the two treatment groups were headache (2.4%), gastroenteritis (2.4%), and upper respiratory tract infection (5.3%).
The large fraction of these undesirable events was established to be unrelated to treatment.
An Overview of Rosacea
Mayo Clinic describes rosacea as a widespread skin condition that leads to apparent blood vessels and redness in an individual’s face. Its symptoms and indicators may break out for weeks or months and then fade for a while. Some people can mistake it for skin problems such as acne, which is an allergic reaction.
The details in this press release comprise of futuristic accounts and information. These include the corporation’s plans, strategies, objectives, and projections. Furthermore, the statements revolve around uncertainties and risks, which could cause accurate results to vary materially from the predictions.
Also, they contain but are not restricted to statements concerning the therapeutic effects and safety of BPX-04, the impact it may have on treating rosacea, and outcomes of imminent analysis related to BPX-04. It is essential to note that these statements are made only as at this date, and the firm has no obligation to modify such records openly.
In a nutshell, the trial’s major endpoint for the Phase 2b study is a complete change of the mean in the number of inflammatory sessions. BioPharmX intends to announce topline safety and efficiency results in July 2019.