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Bristol Myers' (BMY) Pulmonary Fibrosis Drug Positive in Phase II
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Bristol Myers Squibb (BMY - Free Report) announced the results from a mid-stage study evaluating pipeline candidate BMS-986278 in patients with progressive pulmonary fibrosis (PPF).
BMS-986278 is a potential first-in-class, oral, small-molecule LPA1 antagonist currently being evaluated as a novel antifibrotic treatment for patients with idiopathic pulmonary fibrosis (IPF) and PPF.
A serious and life-threatening interstitial lung disease, pulmonary fibrosis, occurs when lung tissues become damaged and scarred, thus impacting the lungs’ functioning.
This phase II study was a global, randomized study wherein parallel cohorts of patients with IPF and PPF were given 30 mg or 60 mg of BMS-986278 or a matched placebo orally twice daily. There were three phases in the study, a 26-week placebo-controlled treatment period, an optional 26-week active treatment extension period and a 4-week post-treatment follow-up period.
Patients were permitted to take background antifibrotics in the IPF cohort and background antifibrotics and/or immunosuppressants in the PPF cohort. The primary endpoint was the rate of change in the percent predicted forced vital capacity (ppFVC) from baseline to week 26 in the IPF cohort. A key secondary point was the rate of change in ppFVC from baseline through week 26 in the PPF cohort.
Results showed that a twice-daily 60 mg dose of BMS-986278 resulted in a 69% relative reduction in the rate of decline in ppFVC with 26 weeks of treatment versus the placebo arm.
In the 30 mg group, a 42% relative reduction was observed in the while-on-treatment analysis and a 37% relative reduction was observed in the treatment policy analysis.
These positive treatment effects were observed with or without background therapy and BMS-986278 was well tolerated, with rates of adverse events similar to placebo and low discontinuation rates.
In May 2023, results from the IPF cohort of the phase II study showed a 62% relative reduction in the rate of decline in ppFVC with 60 mg BMS-986278 versus placebo with or without background therapy.
Based on these positive data, the candidate will now be evaluated in the global phase III ALOFT trial program.
Bristol Myers is currently in transition mode as it shifts its mature product portfolio, which is facing generic competition, to new drugs.
Shares of the company have lost 15.5% year to date compared with the industry's decline of 13.4%.
Image Source: Zacks Investment Research
The approval of drugs like Opdualag, Reblozyl, Breyanzi and Sotyktu has already added a new stream of revenues to BMY’s top line.
The approval of additional new drugs and the label expansion of existing ones will enable Bristol Myers to diversify its product base and offset the slowdown in top-line growth as Revlimid and Eliquis face generic competition
Zacks Rank and Stocks to Consider
Bristol Myers currently carries a Zacks Rank #3 (Hold).
Loss estimates for Dynavax for 2023 have narrowed to 24 cents from 56 cents in the past 90 days, while earnings estimates for 2024 are pegged at 2 cents per share.
Shares of EXEL have gained 37.8% year to date. Earnings estimates for 2023 have risen by 9 cents to 98 cents.
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Bristol Myers' (BMY) Pulmonary Fibrosis Drug Positive in Phase II
Bristol Myers Squibb (BMY - Free Report) announced the results from a mid-stage study evaluating pipeline candidate BMS-986278 in patients with progressive pulmonary fibrosis (PPF).
BMS-986278 is a potential first-in-class, oral, small-molecule LPA1 antagonist currently being evaluated as a novel antifibrotic treatment for patients with idiopathic pulmonary fibrosis (IPF) and PPF.
A serious and life-threatening interstitial lung disease, pulmonary fibrosis, occurs when lung tissues become damaged and scarred, thus impacting the lungs’ functioning.
This phase II study was a global, randomized study wherein parallel cohorts of patients with IPF and PPF were given 30 mg or 60 mg of BMS-986278 or a matched placebo orally twice daily. There were three phases in the study, a 26-week placebo-controlled treatment period, an optional 26-week active treatment extension period and a 4-week post-treatment follow-up period.
Patients were permitted to take background antifibrotics in the IPF cohort and background antifibrotics and/or immunosuppressants in the PPF cohort. The primary endpoint was the rate of change in the percent predicted forced vital capacity (ppFVC) from baseline to week 26 in the IPF cohort. A key secondary point was the rate of change in ppFVC from baseline through week 26 in the PPF cohort.
Results showed that a twice-daily 60 mg dose of BMS-986278 resulted in a 69% relative reduction in the rate of decline in ppFVC with 26 weeks of treatment versus the placebo arm.
In the 30 mg group, a 42% relative reduction was observed in the while-on-treatment analysis and a 37% relative reduction was observed in the treatment policy analysis.
These positive treatment effects were observed with or without background therapy and BMS-986278 was well tolerated, with rates of adverse events similar to placebo and low discontinuation rates.
In May 2023, results from the IPF cohort of the phase II study showed a 62% relative reduction in the rate of decline in ppFVC with 60 mg BMS-986278 versus placebo with or without background therapy.
Based on these positive data, the candidate will now be evaluated in the global phase III ALOFT trial program.
Bristol Myers is currently in transition mode as it shifts its mature product portfolio, which is facing generic competition, to new drugs.
Shares of the company have lost 15.5% year to date compared with the industry's decline of 13.4%.
Image Source: Zacks Investment Research
The approval of drugs like Opdualag, Reblozyl, Breyanzi and Sotyktu has already added a new stream of revenues to BMY’s top line.
The approval of additional new drugs and the label expansion of existing ones will enable Bristol Myers to diversify its product base and offset the slowdown in top-line growth as Revlimid and Eliquis face generic competition
Zacks Rank and Stocks to Consider
Bristol Myers currently carries a Zacks Rank #3 (Hold).
A couple of better-ranked stocks in the overall healthcare sector are Dynavax Technologies (DVAX - Free Report) and Exelixis (EXEL - Free Report) , each currently carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Loss estimates for Dynavax for 2023 have narrowed to 24 cents from 56 cents in the past 90 days, while earnings estimates for 2024 are pegged at 2 cents per share.
Shares of EXEL have gained 37.8% year to date. Earnings estimates for 2023 have risen by 9 cents to 98 cents.