Gilead has struck a deal to acquire PepStar Therapeutics’ oral IL-23 receptor inhibitor program for $1.275 billion, positioning itself as a would-be challenger to Johnson & Johnson’s Icotyde across a range of inflammatory diseases.
Injectable IL-23 drugs are big business. Skyrizi racked up nearly $10 billion for AbbVie over the first half of the year, and J&J has talked up Icotyde’s launch without sharing sales data. Skyrizi is typically administered via subcutaneous injection, although initial intravenous infusion doses are required for some indications. Patients take Icotyde orally once daily.
Gilead is betting big that there is room for another product. The big biotech is acquiring global rights to PepStar’s IL-23 receptor inhibitor program, including HCXT-2001, from the Shanghai-based company in return for the upfront payment. HCXT-2001 is in phase 1 development.
BMO Capital Markets analysts welcomed the deal in a note to investors, calling it “a logical complement to emvistegrast that sets up a potential all-oral combination.” Emvistegrast, Gilead’s inhibitor of the α4β7 pathway, recently impressed in a phase 2 trial.
Researchers added an HCXT-2001 study to China’s clinical trial registry in August and uploaded a second study to the database the following month. Both trials are enrolling healthy volunteers and assessing the effect of food on HCXT-2001.
The second study is assessing single doses of “HCXT-2001 Tablets (A).” A third clinical trial, which is enrolling healthy adults in New Zealand, is testing “HCXT-2001 Tablets” and “HCXT-2001 Tablets (A).”
HCXT-2001 is an oral macrocyclic peptide inhibitor of the IL-23 receptor. As J&J has shown with Icotyde, oral macrocyclic peptides can survive the gut to hit targets traditionally engaged by injectable medicines. However, food can affect the absorption of these drugs. Patients must wait (PDF) at least 30 minutes after taking Icotyde before eating. Merck & Co.’s Lipfendra has the same restriction.
Targeting markets already served by Icotyde, PepStar extended the half-life of HCXT-2001. The first phase 1 trial could test daily and weekly administration of HCXT-2001 in its multiple-ascending-dose stage. Less frequent dosing and the potential to combine the peptide with emvistegrast “could represent key points of differentiation” for HCXT-2001, BMO analysts said.
While HCXT-2001 is in early development, the asset could ultimately challenge drugs including Icotyde across a range of indications. IL-23 is implicated in an array of immune-mediated inflammatory diseases. Icotyde is approved for plaque psoriasis, while Skyrizi’s label covers plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis.