Apogee Therapeutics filed a $100 million initial public offering late last week and with it a plan to compete against Dupixent, one of the pharma world’s top-selling anti-inflammatory drugs.

The one-year-old biotech, based in Waltham, Massachusetts, is focused on developing “differentiated” treatments in the inflammatory and immunology (I&I) space. Its most advanced programs are IL-13 antibody APG777 and IL-4Rα antibody APG808. They’re in preclinical testing for treating atopic dermatitis (AD) and chronic obstructive pulmonary disease (COPD), respectively. 

With those indications, the company has its sights set on competing with Sanofi and Regeneron’s Dupixent, the targeted immunomodulator which achieved megablockbuster status with $8.6 billion in sales last year. 

Dupixent, which inhibits IL-4 and IL-13, is the only targeted biologic that’s Food and Drug Administration-approved for moderate-to-severe AD, a chronic inflammatory skin disorder affecting about 40 million adults and 18 million children in the U.S. The treatment is injected subcutaneously every two weeks.

Analysts have said AD is a growing therapeutic category capable of supporting multiple blockbusters that are differentiated through safety, efficacy and/or dosing convenience.

“Based on our preclinical studies, we believe APG777 can be dosed either every two or every three months in maintenance, which, if our clinical trials are successful, would represent a significant improvement compared to first generation IL-13 antibodies that are dosed every two to four weeks,” Apogee stated in a preliminary prospectus.

The firm said it filed for approval to start human clinical trials in Australia and anticipates initiating a Phase 1 clinical trial of APG777 in healthy volunteers later this year, subject to regulatory clearance. Pharmacokinetic and safety data from the trial are expected in mid-2024. 

Dupixent, whose additional indications cover asthma, chronic rhinosinusitis with nasal polyps (CRSwNP) and eosinophilic esophagitis (EoE), is also a case study in how uptake in a mix of major and obscure disease areas can lead to outsized commercial success. 

In March, Regeneron and Sanofi announced positive Phase 3 data for Dupixent in COPD. The disease, which affects approximately 32 million U.S. adults, could unlock yet another blockbuster indication for the drug.

With APG777, Apogee said it will look to take a page out of Dupixent’s playbook. Based on results, it may initiate a Phase 2 trial in asthma and plans to evaluate further I&I opportunities, including CRSwNP and EoE, as well as alopecia areata (AA), chronic spontaneous urticaria (CSU), and prurigo nodularis (PN).

APG808 can be dosed either every six weeks or every two months, per the company. Apogee has not yet nominated a development candidate for the program but expects to do so this year, after which it will file an IND to start clinical trials.

The company is taking other actions to gear up for bringing these medicines into commercialization. 

This month, Apogee added William “BJ” Jones to its board of directors. Jones most recently served as chief commercial officer, migraine & common diseases at Biohaven Pharmaceuticals, where he launched migraine drug Nurtec. After Biohaven was acquired by Pfizer for $11.6 billion last year, Jones was responsible for the company’s commercial integration. 

Also brought onto the board was healthcare investment banking leader Jennifer Fox, currently CFO at public firm Nuvation Bio. Fox is a veteran advisor on all matters pertaining to M&A, corporate strategy, business development and financing strategies. She will also chair Apogee’s audit committee.

According to the prospectus, the company lost $12.5 million, or $2.51 a share, in the first quarter, versus losses of $4.3 million, or $4.19 a share, in the year-ago period. 

“Even if this offering is successful, we will require substantial additional capital to finance our operations in the future,” Apogee wrote as one of its risk factors.

The biotech company did not provide the number of shares it intends to sell or a price range. Underwriters of the IPO include ​Jefferies as well as TD Cowen, and the biotech said it would trade on the Nasdaq under the symbol APGE.