aTyr hits record low as lung disease drug fails in late-stage trial

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By Padmanabhan Ananthan

(Reuters) – Drug developer aTyr Pharma’s experimental drug failed to meet the main goal in a late-stage study for the treatment of a type of lung disease, the company said on Monday, sending its shares plunging more than 80% to a record low.

The drug, called efzofitimod, was being tested for pulmonary sarcoidosis, a condition that causes the formation of small clumps of inflammatory cells called granulomas impacting the lungs and lymph nodes.

Among the 268 patients enrolled, those on the higher 5 mg/kg dose of efzofitimod reduced steroid use to 2.79 mg a day from baseline, compared with 3.52 mg on placebo, a difference that was not statistically significant.

Despite the setback, the company said it saw benefit for the use of efzofitimod and would meet with the U.S. Food and Drug Administration to review the results and determine the path forward.

“Patients start to feel better, and they continue to feel substantially better compared to their placebo counterparts all throughout the year, while maintaining zero to low steroids,” CEO Sanjay Shukla said in a conference call.

“I view it as a maintenance therapy that could fit really well into current standard of care,” he added.

The company also said more patients on its drug showed withdrawal from use of steroids at 48 weeks.

While the main goal was missed, “we do not believe the door is shut for efzofitimod in pulmonary sarcoidosis with a potential ‘green-light’ for filing after regulator engagement,” said Piper Sandler analyst Yasmeen Rahimi.

Approved treatments for the condition include corticosteroids like prednisone, which are used as the first line of therapy.

Shares of aTyr hit a record low of $1.14.

(Reporting by Padmanabhan Ananthan in Bengaluru; Editing by Pooja Desai and Shailesh Kuber)