Dermira Inc. (DERM) announced positive results from Phase 2b study for treating patients with atopic dermatitis, a condition which causes redness, dryness and itching. Shares of Dermira skyrocketed more than 100% and hit a new 52-week high ($14.91) during today morning’s trading session.
Dermira, which was founded in 2010 and became public company in 2014, plans to speed up the start of Phase 3 development program for lebrikizumab (eczema treating drug) after the positive trial results. Following and end-of-Phase 2 meeting with the FDA, Dermira plans to initiate the program by the end of 2019.
Dermira stated that all three doses of lebrikizumab met the primary endpoint. Patients treated with lebrikizumab at the 250 mg dose every two or four weeks achieved statistically significant improvements in other key efficacy measures compared to placebo after 16 weeks of treatment.
“Based on the clinical profile observed in this study, we believe lebrikizumab has the potential to be a best-in-disease therapy for atopic dermatitis,” said CEO Tom Wiggans. He also added, “We intend to move quickly into a Phase 3 program following discussions with U.S. regulators”.
Last month, Dermira and Barcelona, Spain-based Almirall entered into an option and license agreement to develop and commercialize lebrikizumab for atopic dermatitis in Europe. Under the agreement terms, the Menlo Park, California-based biopharmaceutical firm will receive an option fee of $30 million.
Dermira reported its fourth quarter results on February 26. The company’s loss widened to $71.8 million or $1.70 per share compared to a loss of $56 million or $1.34 per share in the prior year quarter. Revenue stood at $2.2 million, comprised exclusively of QBREXZA product sales, compared with $1.3 million of collaboration and license revenue in the fourth quarter of 2017.
Dermira stock had gained 82% since the beginning of this year and 34% in the past three month period.