Regeneron and Sanofi Announce Mixed Results from COPD Trials
The AERIFY-1 trial reported a significant reduction in COPD exacerbations, while AERIFY-2 fell short of its primary endpoint.
Clinical Trial Outcomes
Regeneron Pharmaceuticals and Sanofi revealed that their Phase 3 trial, AERIFY-1, demonstrated a 27% reduction in moderate to severe COPD exacerbations among former smokers treated with itepekimab, compared to placebo. Conversely, the AERIFY-2 trial did not meet its primary endpoint, though early benefits were indicated. Safety profiles for itepekimab were consistent with prior studies, as both trials reported general tolerability. The companies are currently reviewing the data and plan to engage with regulatory authorities regarding next steps. They remain focused on developing itepekimab for other respiratory conditions, recognizing the complexity of COPD and the need for effective treatments.
Highlights of AERIFY-1
- The AERIFY-1 trial achieved a statistically significant 27% reduction in COPD exacerbations, providing a clinically meaningful benefit.
- Both trials showed itepekimab was well tolerated with consistent safety profiles.
- Regeneron and Sanofi are dedicated to advancing the itepekimab program, addressing unmet needs in respiratory disease.
Caveats from AERIFY-2
- The AERIFY-2 trial did not meet its primary endpoint, potentially diminishing confidence in itepekimab’s overall efficacy.
- Total exacerbation numbers were lower than expected, which could impact the statistical credibility of the results.
- Enrollment during the COVID-19 pandemic may have affected trial outcomes, raising concerns about their validity in typical settings.
Frequently Asked Questions
What were the findings from the AERIFY-1 trial?
The AERIFY-1 trial demonstrated a 27% reduction in moderate to severe COPD exacerbations compared to placebo.
Did AERIFY-2 meet its primary endpoint?
No, the AERIFY-2 trial did not meet its primary endpoint, although some early benefits were noted.
How was the safety of itepekimab assessed in the trials?
Itepekimab was generally well tolerated, with safety consistent throughout both AERIFY-1 and AERIFY-2 trials.
What are Regeneron and Sanofi’s next steps?
They will analyze the data and discuss potential actions with regulatory authorities.
What is itepekimab’s role in treating COPD?
Itepekimab is an experimental treatment targeting interleukin-33 to reduce inflammation in COPD patients.
Disclaimer: This summary is based on a press release from GlobeNewswire. The AI model may contain inaccuracies. For more details, view the full release here.
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Full Release
AERIFY-1 trial met its primary endpoint with a 27% reduction in moderate or severe exacerbations in former smokers, indicating a clinically meaningful benefit.
AERIFY-2 did not meet its primary endpoint, despite observing earlier benefits.
Itepekimab was well tolerated in both trials, with a safety profile consistent with previous clinical studies.
Regeneron and Sanofi are reviewing the data and planning discussions with regulatory authorities.
TARRYTOWN, N.Y. and PARIS, May 30, 2025 (GLOBE NEWSWIRE) — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi reported that the Phase 3 trial AERIFY-1, assessing itepekimab in former smokers with uncontrolled COPD, met its primary endpoint by significantly reducing moderate or severe exacerbations by 27% at week 52.
# Itepekimab Trials Show Mixed Results for COPD Treatment
## Trial Overview and Randomization
The trials AERIFY-1 and AERIFY-2 assessed the efficacy of itepekimab in reducing acute moderate or severe COPD exacerbations. Patients were randomized to receive either itepekimab every two weeks, every four weeks, or a placebo, all while continuing standard-of-care therapy. AERIFY-1 included 1,127 participants and AERIFY-2 had 629.
## Efficacy Results
The primary endpoint focused on the reduction in the annualized rate of COPD exacerbations. While improvements were noted earlier in the trials, neither trial met the primary endpoint by their conclusion. The table below summarizes the reductions in exacerbations between itepekimab and placebo for both trials at weeks 24 and 52:
| AERIFY-1 | AERIFY-2 | ||||||
| Week 24 | Week 52 | Week 24 | Week 52 | ||||
| Itepekimab
every two weeks |
30% | 27%a | 18% | 2% | |||
| Itepekimab
every four weeks |
34% | 21%a | 21% | 12% | |||
The formal significance testing was only conducted at 52 weeks. Both dosing schedules demonstrated significance in AERIFY-1.
## Overall Exacerbation Rates
The total exacerbations were lower than anticipated, reducing the trials’ statistical power. Enrollment occurred mostly during the COVID-19 pandemic, potentially affecting exacerbation rates.
## Safety and Adverse Events
The safety profile for itepekimab was consistent across both dosing schedules. In AERIFY-1, adverse event rates were 67% for itepekimab every two weeks, 68% for every four weeks, and 68% for placebo. AERIFY-2 showed rates of 64% and 71% for the two dosing regimens, compared to 64% for placebo. Serious infection rates were similar, at 7% for both itepekimab arms in AERIFY-1 against 10% for placebo.
## Future Steps
George D. Yancopoulos, President and Chief Scientific Officer at Regeneron, highlighted the complexity of COPD and the need for novel treatments. Regeneron and Sanofi are reviewing trial data and plan consultations with regulatory authorities regarding the next steps.
## Presentation of Results
Detailed results from these trials will be presented at future events.# Sanofi and Regeneron Report Preliminary Results for Itepekimab in COPD Trials
**Overview of AERIFY Trials**
Sanofi and Regeneron presented early results from AERIFY-1 and AERIFY-2 trials, assessing the monoclonal antibody itepekimab for chronic obstructive pulmonary disease (COPD). These Phase 3 studies involved 2,080 adults aged 40-85 who were former smokers with moderate-to-severe COPD.
**Trial Details and Results**
The trials aimed to determine the efficacy and safety of itepekimab when added to existing therapies. AERIFY-1 included 1,127 participants while AERIFY-2 had 953. Both trials primarily measured the annualized rate of moderate or severe COPD exacerbations, which necessitate systemic steroids, hospitalization, or emergency observation.
Dr. Houman Ashrafian of Sanofi stressed the importance of further analysis on the role of IL-33 in COPD treatment, highlighting the urgent need for effective therapies for patients enduring exacerbations despite existing treatments.
**Safety and Development Status**
Currently, the safety and efficacy of itepekimab remain under investigation and not yet evaluated by regulatory authorities.
**Ongoing Research**
The AERIFY program includes two more trials: AERIFY-3, a Phase 2 mechanistic study on airway inflammation in COPD, and AERIFY-4, a Phase 3 trial focused on long-term safety.
**About Itepekimab**
Itepekimab targets interleukin-33, a key player in inflammation associated with COPD. This antibody was developed using Regeneron’s VelocImmune technology and is also being assessed for chronic rhinosinusitis conditions.
**Company Backgrounds**
Regeneron (NASDAQ: REGN) focuses on developing transformative medicines, while Sanofi is committed to advancing health through innovative therapies. Both companies collaborate on the development of itepekimab.
**Conclusion**
As ongoing trials progress, results will inform the potential of itepekimab as a new treatment option for COPD and related inflammatory conditions. Further discussions with regulatory bodies are expected to shape its development path.# Regeneron Faces Challenges with Its Product Candidates
### Overview of Product Development and Regulatory Approval
Regeneron Pharmaceuticals is advancing its product candidates, including itepekimab for chronic obstructive pulmonary disease (COPD) and other indications. The company is currently evaluating the likelihood and timing of regulatory approval for these products.
### Key Trials and Indications
Itepekimab is under investigation for use in adults with COPD, particularly former smokers. Additional indications include chronic rhinosinusitis with and without nasal polyps. Feedback from the AERIFY-1 and AERIFY-2 trials is anticipated to affect the potential approval process.
### Regulatory and Market Challenges
Regeneron faces uncertainty regarding market acceptance and commercial success of its products. Factors such as regulatory feedback, competition from superior drugs, and intellectual property issues may influence the development trajectory of itepekimab.
### Supply Chain and Safety Concerns
The ability to manage supply chains effectively remains critical, especially with potential risks from tariffs and trade restrictions. Furthermore, safety issues and potential complications during clinical trials could pose risks to advancing its products.
### Financial Projections and Risks
Regeneron cautions that various risks, including unexpected costs and changes in reimbursement policies from third parties, may impact its financial projections. Delays or complications arising from regulatory bodies could also hinder development.
### Sanofi’s Collaborative Efforts and Statements
Sanofi, a collaborator with Regeneron, has issued forward-looking statements concerning potential revenues and product success. These statements highlight various uncertainties that could affect market performance and operational efficiency.
### Conclusion
Investors are encouraged to review Regeneron’s filings with the U.S. Securities and Exchange Commission for a comprehensive understanding of the risks involved. The company does not assume any duty to update its forward-looking statements continually.
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