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Bristol Myers lung drug succeeds at low dose, misses at high dose

Bristol Myers lung drug succeeds at low dose, misses at high dose

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Phase 3 ALOFT-IPF trial meets goal at 60mg dose, misses at 120mg

Today: Phase 3 ALOFT-IPF results announced

Overview

Updated 1 hour ago

Bristol Myers Squibb's experimental lung disease drug admilparant met its main goal in a late-stage trial, but only at the lower of two tested doses. The 60 milligram dose significantly slowed the decline in lung function among patients with idiopathic pulmonary fibrosis, while the 120 milligram dose missed the statistical threshold.

The mixed result sent Bristol Myers shares down about 4% and left analysts puzzled. A drug that works at a lower dose but not a higher one is unusual. The outcome raises questions about admilparant's profile even as it validates a new class of IPF treatments.

Why it matters

If approved, admilparant would be the first new class of IPF treatment in years, offering patients an alternative to drugs with significant side effects.

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Key Indicators

~4%
Bristol Myers stock change
Shares fell after the mixed ALOFT-IPF results were announced.
~30%
Contineum Therapeutics stock change
The rival LPA1 drug developer's stock fell sharply on the news.
1,255
Patients in ALOFT-IPF trial
Approximately 1,255 adults with IPF were enrolled in the Phase 3 trial.
1 of 2
Doses meeting primary endpoint
Only the 60mg dose met the primary endpoint; the 120mg dose missed.

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Timeline

September 2026 October 2026

3 events Latest: Today
  1. Phase 3 ALOFT-IPF results announced

    Today Clinical Trial

    Bristol Myers announced topline results: the 60mg dose of admilparant met the primary endpoint in FVC change from baseline to Week 52, while the 120mg dose missed. Stock fell about 4%.

  2. Death reported in ALOFT program

    Safety

    Bristol Myers reported a death from multi-organ failure after acute liver injury in the ALOFT program. The patient was in the 120mg arm; an adjudication committee determined the death was unlikely related to study treatment.

  3. BMS changes safety monitoring protocols in Europe

    Regulatory

    Bristol Myers changed safety monitoring protocols in Europe for admilparant's ALOFT trials, fueling analyst and investor concern about liver safety.

Scenarios

1

BMS files for FDA approval of admilparant

Likely Resolves by Q2 2027

Discussed by: BMO Capital Markets, William Blair

Bristol Myers completes its evaluation of the ALOFT-IPF data and submits a New Drug Application to the FDA. The 60mg dose's success, combined with the well-tolerated safety profile, supports the filing. BMO analysts called the data 'a derisked regulatory submission path for Bristol pending full data release.'

2

FDA requires additional data before approval

Possible Resolves by End of 2027

Discussed by: Leerink Partners, RBC Capital Markets

The lack of dose response and lingering liver safety concerns lead the FDA to request additional data or a confirmatory trial before considering approval. Leerink's David Risinger noted the results 'could be sufficient to support regulatory approval, but the lack of dose response raises questions about admilparant's profile.'

3

ALOFT-PPF results strengthen admilparant's case

Uncertain Resolves by Q1 2027

Discussed by: Bristol Myers Squibb, industry analysts

The Phase 3 ALOFT-PPF trial in progressive pulmonary fibrosis reads out in early 2027. If the 60mg dose meets its primary endpoint there too, it would reinforce the drug's efficacy and support the approval case. BMS chief medical officer Cristian Massacesi said the company looks forward to sharing those results.

Historical Context

2 moments from history that rhyme with this story — and how they unfolded.

2010s

Earlier LPA1 antagonist failures (2010s)

Bristol Myers scrapped an earlier LPA1 antagonist because of liver toxicity in clinical testing. Amgen also canceled its LPA1 drug after it fell short in a Phase 2 trial.

Then

The failures left the LPA1 class unproven and raised the bar for any new drug in the class.

Now

Admilparant became the first LPA1 antagonist to reach Phase 3 testing, carrying the class's hopes.

Why this matters now

Admilparant is the first LPA1 antagonist to succeed in a Phase 3 trial, but the liver safety concerns that sank earlier drugs in the class still hang over it.

Ongoing

Current IPF treatments and their limits

The current standard of care for IPF includes Esbriet, Ofev and Jascayd, which slow lung function decline but have significant side effects and limited efficacy.

Then

Patients still face a progressive, life-threatening disease with few good options.

Now

The limitations of existing drugs have left room for new treatments with different mechanisms.

Why this matters now

Admilparant works through a different mechanism, which could make it a combination partner or an alternative for patients who can't tolerate existing drugs.

Sources

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