AbbVie is discontinuing a cystic fibrosis medicine after an interim analysis revealed that the therapy did nothing when added to a two-drug regimen, putting a dent in the pharma’s efforts to compete with Vertex’s Trikafta.
An interim analysis of a phase 2 trial did not meet AbbVie’s prespecified criteria to move the study forward, Senior Vice President of R&D and Chief Scientific Officer Thomas Hudson, M.D., said on a Friday earnings call.
Patients in the study received a dual combo of AbbVie’s C1 corrector and potentiator therapies for 28 days followed the C2 corrector ABBV-119 for 20 days. ABBV-119 did not provide any meaningful improvement compared to patients who received only the dual therapy, which performed as expected.
AbbVie will now move forward with the dual treatment, leaving ABBV-119 for the trash can.
But the company is still eyeing a triple-attack regimen with a C2 corrector, which will advance into studies with a different C1 corrector called ABBV-576. Hudson said this C2 corrector is different from the failed ABBV-119, has a better safety profile and could yield higher efficacy.
A phase 2 triple-combo study featuring ABBV-3067, ABBV-2222 and ABBV-576 should get underway early next year, according to Hudson.
RBC Capital Markets analysts said the failure of ABBV-119 was in line with expectations even if the results were highly anticipated by investors. The firm believed that the medicine was crucial to a triple-attack needed to challenge Vertex’s approved med Trikafta, which combines three different therapies into one. The results further relieve pressure on Vertex.
But another company that may be reeling from the results is Galapagos, which had been hoping for some royalties from a successful readout for ABBV-119. AbbVie bought out the troubled biotech’s cystic fibrosis pipeline for $45 million upfront in 2018. A series of setbacks have sent Galapagos and its new CEO Paul Stoffels back to the drawing board. A little cash from AbbVie from this long-ago deal would have been a nice boost.
Even when the buy was made, the portfolio underwhelming data suggesting Galapagos’ drugs may struggle to go up against Vertex’s winning offerings.
As for the new triple combo AbbVie is planning, RBC said today’s news highlights the risk in cystic fibrosis, so time will tell if the plan helps the pharma advance in the disease.