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LONDON, UK / ACCESSWIRE / October 12, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for AnaptysBio, Inc. (NASDAQ: ANAB), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/?symbol=ANAB. The clinical-stage Biotechnology Company, developing product candidates for unmet medical needs in inflammation, announced on October 10, 2017, positive proof-of-concept data for ANB020 in the ongoing Phase-2a clinical trial in adult patients suffering from moderate-to-severe atopic dermatitis. The results indicate that after a single dose of ANB020, 75% of patients achieved an Eczema Area Severity Index (EASI) score improvement of 50% compared to the enrolment baseline (EASI-50) at day 15; 83% patients attained EASI-50 at day 29; and 75% patients reached EASI-50 at day 57. In fact, all 12 patients achieved EASI-50 at one or more time points during the 57-day time period of the interim analysis. For immediate access to our complimentary reports, including today's coverage, register for free now at:
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ANB020 is an antibody that binds and inhibits the activity of interleukin-33, or IL-33, a pro-inflammatory cytokine, which is believed to be a central mediator of atopic diseases such as asthma, food allergies, and atopic dermatitis. Post successful completion of the Phase-1 trial, AnaptysBio is extending the clinical development of ANB020 into Phase-2a studies for moderate-to-severe adult atopic dermatitis, severe adult peanut allergy, and severe adult eosinophilic asthma.
About Phase-2a Trial
- The Phase-2a proof-of-concept trial enrolled 12 moderate-to-severe adult atopic dermatitis patients, who were originally administered a single intravenous dose of placebo within 14 days of enrollment. This was followed by a single intravenous 300mg dose of ANB020 one week after placebo.
- The clinical response for the treatment was evaluated through the improvement of each patient's EASI score, which is a tool used to gauge the extent of atopic dermatitis at important time points following ANB020 administration relative to their enrollment baseline.
- Moreover, the trial also included assessment of pruritus for each patient. The 5-D pruritus scale score measured pruritus, which is basically itchiness.
- The exploratory mechanistic biomarkers included granulocyte infiltration and cytokine levels in localized skin lesions. These were measured five days after placebo administration and five days after ANB020 administration.
Results of the Interim Analysis
Presently, the Phase-2a study is in progress and EASI scores will be measured for all patients for up to 140 days post-ANB020 treatment. AnaptysBio intends to report full data from this trial at a medical conference, after the completion of the study. However, an interim analysis was conducted after all 12 patients reached day 57 after a single administration of ANB020. It indicated the following:
- The average baseline EASI score upon enrollment was 32. The average decline in EASI scores pruritus score at seven days post-placebo administration was 4% and 10%, respectively. In fact, all 12 patients were inadequately controlled by topical corticosteroids while 7 were treated with systemic non-biologic anti-inflammatory therapy before the screening washout period of this trial.
- The rapid clinical response was observed at day 15 post-ANB020 administrations. Nine out of 12 patients (i.e. 75%) achieved EASI-50. Out of this, 3 patients (i.e. 25%) accomplished EASI score improvement of 75% compared to the baseline (EASI-75). The average EASI score reduction at day 15 was 58% while average pruritus reduction was 28% compared to baseline.
- At day 29 post-ANB020 administrations, 10 out of 12 patients (i.e. 83%) achieved EASI-50. Of this, 4 patients (i.e. 33%) also reached EASI-75. The average EASI score decline at this time point was 61% and the average pruritus reduction was 32% versus the baseline.
- At day 57, sustained clinical response was observed post-ANB020 administrations. Nine out of 12 patients (i.e. 75%) got EASI-50, of which five patients (i.e. 42%) also achieved EASI-75. The average EASI reduction was 62% while the average pruritus reduction was 21% relative to baseline.
- Besides, the exploratory biomarker assessment showed a lessening of granulocyte infiltration into localized skin lesions by around 30% amongst all patients, and 60% among the 10 patients achieving EASI-50 at 29 days post-ANB020 administrations. The exploratory cytokine biomarker levels were below the detection limit and therefore inconclusive.
- ANB020 was mostly well tolerated by all patients. No serious adverse events have been reported up till now. The common treatment-emergent adverse events that were reported include mild dizziness in two patients after placebo dosing, and mild headache in two patients after ANB020 administration.
Committed To Fulfill Unmet Medical Needs in Inflammation
Dr. Graham Ogg, Professor of Dermatology at the University of Oxford and Primary Investigator of the Phase-2a study, highlighted that moderate-to-severe atopic dermatitis is a serious disease related to chronic skin inflammation and debilitating pruritus. Currently, it is clearly an unmet medical need. He stated that, after observation, a single dose of ANB020 had a rapid and sustained effect on patients is an encouraging interim result from the trial. Dr. Ogg looks forward to the continued development of ANB020 as a potential future therapeutic option for patients suffering from atopic dermatitis.
Hamza Suria, President and Chief Executive Officer at AnaptysBio, mentioned that the latest efficacy results from the Phase-2a study are very encouraging. This is indicative of AnaptysBio's strategic focus on developing first-in-class anti-inflammatory antibody therapeutics to relieve patients suffering from incapacitating inflammatory diseases. He said that he was eager for advancing the development of ANB020 for the treatment of patients with atopic diseases.
Future Plans for ANB020
AnaptysBio continues to develop its ongoing ANB020 Phase-2a studies in adults with severe peanut allergy and adults with severe eosinophilic asthma. The top-line data for adults with peanut energy is expected in the fourth quarter of 2017, while top-line data for adults with asthma is expected in the first half of 2018.
Furthermore, AnaptysBio plans to initiate a Phase-2b randomized, double-blinded, placebo-controlled study in 200-300 adult patients with moderate-to-severe atopic dermatitis. The study is intended to assess the multi-dose subcutaneous administration of ANB020. The data from this study is expected in 2019.
Last Close Stock Review
At the closing bell, on Wednesday, October 11, 2017, AnaptysBio's stock fell slightly by 0.67%, ending the trading session at $69.94. A total volume of 1.20 million shares have exchanged hands, which was higher than the 3-month average volume of 328.65 thousand shares. The Company's stock price soared 117.95% in the last one month, 167.46% in the past three months, and 175.57% in the previous six months. Moreover, the stock skyrocketed 311.41% since the start of the year. The stock currently has a market cap of $1.39 billion.
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