On November 8, 2018 AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on unmet medical needs in inflammation, reported operating results for the third quarter ended September 30, 2018 and provided pipeline updates (Press release, AnaptysBio, NOV 8, 2018, View Source [SID1234531162]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"We continued to advance the clinical development of our wholly-owned etokimab and ANB019 programs for severe inflammatory disease indications during the third quarter of 2018," said Hamza Suria, president and chief executive officer of AnaptysBio. "Top-line data from our etokimab Phase 2a trial in severe adult eosinophilic asthma patients demonstrated rapid and sustained improvement in Forced Exhaled Volume In One Second versus placebo, with corresponding reduction in blood eosinophil levels. We look forward to further advancement of our wholly-owned pipeline with four additional readouts from ongoing clinical trials of etokimab and ANB019 during 2019."
Etokimab (ANB020 Anti-IL-33 Program)
•
In September, the Company announced positive topline proof-of-concept data for etokimab, its investigational anti-IL-33 therapeutic antibody, in an ongoing single dose Phase 2a clinical trial in adult patients with severe eosinophilic asthma. Patients administered with etokimab rapidly improved their Forced Exhaled Volume In One Second, or FEV1, which is a measure of lung function, with an eight percent FEV1 improvement over placebo at Day 2. FEV1 improvement was sustained through Day 64, with an 11 percent increase over placebo. Blood eosinophil reduction was sustained through the interim analysis period, with a 31 percent reduction at Day 2 and a 46 percent reduction at Day 64 over placebo, which was consistent with FEV1 improvement observed in this trial. Etokimab was generally well tolerated in all patients and no serious adverse events were reported as of this interim analysis. This Phase 2a trial is currently ongoing and the company plans to report full data from this trial at a medical conference in 2019 following trial completion. AnaptysBio plans to continue development of etokimab in eosinophilic asthma with a multi-dose Phase 2b randomized, double-blinded, placebo-controlled trial, which is expected to be initiated in 2019.
•
The Company is enrolling a Phase 2b randomized, double-blinded, placebo-controlled, multi-dose study in 300 adult patients with moderate-to-severe atopic dermatitis, also referred to as the ATLAS clinical trial, to assess different dose levels and dosing frequencies of subcutaneously-administered etokimab for a 16-week treatment period followed by an eight-week monitoring period, with data expected in the second half of 2019.
•
The Company has cleared an IND and initiated a randomized, placebo-controlled Phase 2 trial, also referred to as the ECLIPSE trial, in approximately 100 adult patients with chronic rhinosinusitis with nasal polyps. Patients will be treated with two multi-dosing frequencies of subcutaneous-administered etokimab or placebo, each in combination with mometasone furoate nasal spray as background therapy, for a treatment period of 16 weeks followed by an eight-week monitoring period. The Company anticipates top-line data from the ECLIPSE trial will be available in the second half of 2019.
ANB019 (Anti-IL-36 Receptor Program)
•
AnaptysBio has initiated a 10-patient, single arm, open-label Phase 2 trial of ANB019 in generalized pustular psoriasis, or GPP, also known as the GALLOP trial, and top-line data are anticipated in mid-2019.
All patients will be treated with an intravenous loading dose of ANB019 upon enrollment, followed by subcutaneously-administered monthly doses of ANB019 for a treatment period of up to 16 weeks post enrollment and followed by an eight-week monitoring period.
•
AnaptysBio has cleared an IND with the FDA and has initiated a randomized, placebo-controlled 50-patient multi-dose Phase 2 trial in palmoplantar pustulosis, or PPP, also known as the POPLAR trial, where top line data are anticipated in the second half of 2019. Patients will be treated with a (i) a subcutaneously-administered loading dose of ANB019 upon enrollment, followed by subcutaneously-administered monthly doses of ANB019, or (ii) placebo, each for a treatment period of 16 weeks post enrollment and followed an eight-week monitoring period.
Corporate Highlights
•
On September 28, 2018, the Company completed an underwritten public offering of 2,530,000 shares of common stock at a price to the public of $94.46, which included the exercise by the underwriters of their option to purchase an additional 330,000 shares of common stock. AnaptysBio, received net proceeds from the offering of $227.5 million, after deducting underwriting discounts and commissions.
Third Quarter Financial Results
•
Cash, cash equivalents and investments totaled $512.4 million as of September 30, 2018 compared to $324.3 million as of December 31, 2017, for an increase of $188.1 million. The increase primarily relates to net proceeds received by the Company of $227.5 million from the public offering, offset by operating cash outflow for clinical and manufacturing related expenses, as well as personnel costs.
•
Collaboration revenue was $5.0 million for the three and nine months ended September 30, 2018, related to a milestone for the first Phase 3 trial of TSR-042 by TESARO compared to no revenue and $7.0 million for two TESARO milestones for the three and nine months ended September 30, 2017, respectively.
•
Research and development expenses were $17.9 million for the three months ended September 30, 2018, as compared to $6.7 million for the three months ended September 30, 2017. The increase was primarily due to continued advancement of the Company’s etokimab and ANB019 clinical programs and additional personnel-related expenses including share based compensation during the three months ended September 30, 2018.
•
General and administrative expenses were $4.0 million for the three months ended September 30, 2018, as compared to $2.4 million for the three months ended September 30, 2017. The increase was primarily attributable to additional personnel-related expenses, including share based compensation, to support the Company’s growth.
Financial Guidance
AnaptysBio expects that its cash, cash equivalents and investments will fund its current operating plan at least through the end of 2020.
About Etokimab
Etokimab, previously referred to as ANB020, is an antibody that potently binds and inhibits the activity of interleukin-33, or IL-33, a pro-inflammatory cytokine that multiple studies have indicated is a central mediator of atopic diseases, which AnaptysBio believes is broadly applicable to the treatment of atopic inflammatory disorders, such as atopic dermatitis, eosinophilic asthma, chronic rhinosinusitis with nasal polyps, or CRSwNP, and potentially other allergic conditions. Following completion of a healthy volunteer Phase 1 trial of etokimab, AnaptysBio continued clinical development of etokimab into a Phase 2a trial for moderate-to-severe adult atopic dermatitis and a placebo-controlled Phase 2a trial in severe adult eosinophilic asthma patients. AnaptysBio is enrolling its ATLAS trial, a randomized, double-blinded, placebo-controlled multi-dose Phase 2b clinical trial of etokimab in 300 moderate-to-severe adult atopic dermatitis patients where data is anticipated in the second half of 2019. The company has also initiated its ECLIPSE trial, a randomized, double-blinded, placebo-
controlled Phase 2 trial of etokimab in approximately 100 adult patients with CRSwNP with data anticipated in the second half of 2019. AnaptysBio also plans to initiate a randomized, double-blinded, placebo-controlled, multi-dose Phase 2b trial of etokimab in patients with eosinophilic asthma in 2019.
About ANB019
ANB019 is an antibody that inhibits the function of the interleukin-36-receptor, or IL-36R, which AnaptysBio plans to initially develop as a potential first-in-class therapy for patients suffering from generalized pustular psoriasis, or GPP and palmoplantar pustulosis, or PPP. AnaptysBio conducted a Phase 1 clinical trial in healthy volunteers, where 54 subjects are dosed with ANB019 and 18 are dosed with placebo in single and multi-dose cohorts at various subcutaneous and intravenously administered dose levels. In May 2018, AnaptysBio presented data from this Phase 1 clinical trial, which demonstrated favorable safety, pharmacokinetics and pharmacodynamic properties that support advancement of ANB019 into Phase 2 studies. AnaptysBio is enrolling its GALLOP trial, a Phase 2 study of ANB019 in GPP where data is anticipated in the second quarter of 2019, and have initiated its POPLAR trial, a Phase 2 study in PPP where data is anticipated in the second half of 2019.