Cytokinetics reveals unexpected delay; AstraZeneca combo therapy hits in asthma
Today, a brief rundown of news involving Cytokinetics and AstraZeneca, as well as updates from Repare Therapeutics, Amicus Therapeutics and Pliant Therapeutics that you may have missed.
The Food and Drug Administration has delayed an approval decision on Cytokinetics‘ experimental hypertrophic obstructive cardiomyopathy drug aficamten so it can have more time to review the company’s proposed risk management plan. In a statement Thursday, Cytokinetics revealed it had discussed safety and risk mitigation protocols with the agency before filing its application, but didn’t include an official plan in its submission. The FDA requested one during its review and deemed the addition a “major amendment” that will extend the drug’s evaluation by three months. A decision is now expected by Dec. 26. The news surprised analysts and investors, as Cytokinetics executive “had been guiding to proposing a distinct risk mitigation strategy,” wrote Stifel analyst James Condulis. Shares fell by double digits in early trading Friday. — Ben Fidler
AstraZeneca’s combination drug Breztri Aerosphere outperformed inhaled corticosteroid and long-acting beta2-agonist medicines in two replicate Phase 3 studies, significantly improving lung function in people with asthma by a degree the company said Friday was clinically meaningful. The studies, dubbed Kalos and Logos, enrolled roughly 4,400 adults and teenagers with uncontrolled asthma. Breztri is already approved to treat chronic obstructive pulmonary disease in the U.S. and AstraZeneca hopes to use this new data to expand the drug’s use into asthma. The company expects Breztri to eventually generate $3 billion to $5 billion in peak annual revenues. — Ned Pagliarulo
Amicus Therapeutics will pay $30 million to license U.S. rights to a kidney disease drug developed by Australia-based biotech Dimerix, the companies announced Wednesday. Dubbed DMX-200, the drug is designed to treat focal segmental glomerulosclerosis, a rare disorder caused by progressive scarring of the kidney’s principal filtration system. Dimerix has been running a Phase 3 trial of DMX-200 that, at an interim analysis, showed treatment reduced protein levels in the urine, an accepted endpoint for FSGS. Dimerix will retain rights to DMX-200 outside of the U.S., and is eligible for additional payments from Amicus upon achievement of certain milestones. — Ned Pagliarulo
Struggling cancer drug developer Repare Therapeutics has licensed its drug discovery work, intellectual property and certain other assets into a newly launched startup called DCx Biotherapeutics, according to a Friday statement. The startup, backed by Amplitude Ventures, will employ about 20 former Repare workers and develop so-called multi-modal antibody-drug conjugates for cancer. Repare, meanwhile, will get a roughly 10% stake in DCx and could receive unspecified future payments if drugs in the deal progress. — Ben Fidler
Pliant Therapeutics will lay off 45% of its staff as part of a plan to minimize costs and conserve cash as it awaits data from the recently halted late-stage study of its idiopathic pulmonary fibrosis drug, it said Friday. Pliant stopped the trial after two independent panels of trial monitors found an “imbalance” in adverse events between participants given the company’s treatment instead of a placebo. But it hasn’t given up on the drug, choosing instead to wait for final study results, expected this quarter, before determining its next steps. Pliant had 171 full-time employees as of Dec. 31, according to a regulatory filing. — Ben Fidler
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