Hidradenitis suppurativa, also called acne inversa, is a chronic inflammatory skin condition that causes small, painful lumps to form under the skin, particularly in armpits or groin. AbbVie’s injectable biologic Humira is the only FDA-approved treatment for hidradenitis suppurativa. Antibiotics and corticosteroids are also used to manage the symptoms of this condition.<\/p>\n
AnaptysBio Inc. (ANAB), a clinical-stage biotechnology company developing innovative immunology therapeutics, also has a drug candidate targeting hidradenitis suppurativa in its pipeline.<\/p>\n
The drug candidate in focus is Imsidolimab, an antibody that inhibits the function of the interleukin-36-receptor, or IL-36R. Studies have shown that IL-36 expression was increased in tissue samples of Hidradenitis suppurativa patients.<\/p>\n
A phase II trial of Imsidolimab in moderate-to-severe hidradenitis suppurativa, dubbed HARP, is underway, with topline data due this quarter.<\/p>\n
Imsidolimab is also being explored as a potential treatment for generalized pustular psoriasis, a systemic, life-threatening inflammatory disease characterized by widespread pustules. <\/p>\n
A phase III trial of Imsidolimab in generalized pustular psoriasis, dubbed GEMINI-1, and a phase III, long term extension study of Imsidolimab in generalized pustular psoriasis, dubbed GEMINI-2, are underway. Topline data from the GEMINI-1 trial are anticipated in the fourth quarter of next year. <\/p>\n
Also in the pipeline are two other clinical programs – Rosnilimab and ANB032.<\/p>\n
Rosnilimab is an antibody that binds PD-1 in an agonistic manner, leading to reduced T cell activity and anti-inflammatory effects. PD-1 is a protein found on T cells (a type of immune cell) that helps keep the body’s immune responses in check. (Source: National Cancer Institute). <\/p>\n
— A phase II clinical trial of Rosnilimab in moderate-to-severe alopecia areata, dubbed AZURE, is ongoing, with topline data expected in the first quarter of next year.<\/p>\n
ANB032 is an anti-BTLA agonist antibody with a broad potential to treat human inflammatory diseases associated with lymphoid and myeloid immune cell dysregulation.<\/p>\n
— A phase I trial of ANB032, the results of which were reported in April of this year, demonstrated favorable safety and tolerability with no observed dose limiting toxicities and no serious adverse events.<\/p>\n
The company will be seeking FDA clearance to initiate a phase II clinical trial of ANB032 in the fourth quarter of this year.<\/p>\n
Collaboration with GSK<\/p>\n
AnaptysBio has also developed multiple therapeutic antibodies in an immuno-oncology collaboration with GSK, including Jemperli, Cobolimab, and GSK4074386, entitling it to receive royalties on sales of the drugs.<\/p>\n
Q2 Scorecard<\/p>\n
In the second-quarter of 2022, net loss was $32.6 million or $1.15 per share on collaboration revenue of $1.2 million. This compares with a net loss of $0.4 million or $0.02 per share and collaboration revenue of $30 million in the year-ago quarter.<\/p>\n
As of June 30, 2022, the company had cash, cash equivalents and investments totaling $572.1 million.<\/p>\n
AnaptysBio shares began trading on the NASDAQ Global Select Market on January 26, 2017, priced at $15 per share.<\/p>\n
ANAB has traded in a range of $18.20 to $37.89 in the last 1 year. The stock closed Friday’s trading at $26.23, up 4.92%. <\/p>\n