Q3 clearout: Shire dumps rare disease med, Gilead cuts simtuzumab

Print 03 November 2016
Ben Adams / Fierce Biotech

It’s that time of year when biopharmas sneak out negative R&D news amid a swath of financial data, and the FierceBiotech team has delved deep into the reports and found out which programs have been quietly dumped.

Pfizer’s ($PFE) shock announcement that it was killing off all development for its PCSK9 candidate grabbed the headlines this week, but both Shire ($SHPG) and Gilead ($GILD) have also terminated some potentially big programs.

First up, to Gilead. Just two weeks ago, it posted some mixed data for its experimental med GS-4997 (selonsertib), an investigational inhibitor of apoptosis signal-regulating kinase 1, after missing the primary endpoints in both pulmonary arterial hypertension (PAH) and diabetic kidney disease (DKD).

It said it would stop work on these programs, but during its Q3 call, the Big Biotech also announced that selonsertib “will not be progressed further for Crohn’s Disease.”

And that’s not all. During its mixed data release in late October, Gilead also published some slightly confusing figures for selonsertib in nonalcoholic steatohepatitis (NASH), also known as nonalcoholic fatty liver disease, in an open-label Phase II study.

The top-line data looked at both selonsertib alone and in combo with Gilead's simtuzumab, an investigational injected antibody directed against lysyl oxidase-like-2, and it appeared as if adding SIM didn’t do much to help NASH patients.

But its partner for SIM, U.K.-based Abenza (AIM: ABZA), confirmed reports that Gilead was not in fact happy with the med and was ditching further work on it. “Gilead stated that no further development of simtuzumab will be pursued,” Abenza said in a brief statement.

Now to Shire, which quietly got rid of its midstage candidate SHP610, a med that was being studied in patients with Sanfilippo syndrome type A (MPS-IIIA). “The Phase IIb study of SHP610 in pediatric patients with early stage Sanfilippo A did not meet its primary endpoint of slowing the cognitive decline in patients,” Shire said in a brief update amid its financials.  

The Big Biotech said it will now “terminate all clinical trials of SHP610” and plans to publish the results of the SHP610 program “for the benefit of the Sanfilippo community.”

Shire is however not the only co that was testing for this disease area, with Alexion ($ALXN) recently touting its progress on its experimental Sanfilippo B drug, with gene therapy biotech Lysogene and Abeona Therapeutics ($ABEO) also working on Type A forms of the disease.

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