What Is PF-07275315?
PF-07275315 is an investigational drug currently being studied in clinical trials. This means it has not yet been approved by regulatory authorities for general use, and its safety and effectiveness are still under evaluation. The drug is administered as a subcutaneous injection, meaning it is injected under the skin, and is typically provided as a solution for single use. As an active drug, PF-07275315 is being evaluated for its potential therapeutic effects across several conditions. Clinical trials are currently exploring its use in conditions such as asthma, atopic dermatitis, and moderate to severe chronic obstructive pulmonary disease. It is also being studied in healthy volunteers to understand its effects and safety profile. A total of five clinical trials are underway or completed for PF-07275315, with three currently recruiting participants. These trials have enrolled a total of 1,826 participants. The first trial began on 2022-06-09, and the latest is expected to conclude on 2026-01-23. All studies for PF-07275315 are sponsored by Pfizer.
Uses and Conditions Under Study
PF-07275315 is currently being investigated in clinical trials for several inflammatory and respiratory conditions, as well as in healthy individuals to assess its safety and how it behaves in the body.
Inflammatory and Respiratory Conditions:
- Asthma: Asthma is a chronic lung disease characterized by inflammation and narrowing of the airways, leading to symptoms such as wheezing, shortness of breath, chest tightness, and coughing. PF-07275315 is being studied in one trial to determine if it can help manage the underlying inflammation associated with asthma and potentially improve respiratory function for patients.
- Atopic Dermatitis: Also known as eczema, atopic dermatitis is a chronic inflammatory skin condition that causes dry, itchy, and inflamed skin. It often involves an overactive immune response. PF-07275315 is being investigated in one trial to explore its ability to modulate the immune system and reduce the characteristic symptoms of atopic dermatitis.
- Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD): COPD is a progressive lung disease that causes obstructed airflow from the lungs, leading to significant breathing difficulties. It is commonly associated with long-term exposure to irritants like cigarette smoke. PF-07275315 is being studied in one trial for its potential to reduce inflammation and improve lung function in individuals with moderate to severe COPD.
Studies in Healthy Volunteers:
PF-07275315 is also being studied in healthy volunteers across two trials. These studies are essential for understanding the drug's pharmacokinetics – how it is absorbed, distributed, metabolized, and excreted by the body – and for thoroughly evaluating its overall safety and tolerability profile before it is more extensively tested in patient populations with specific conditions.
Dosing
PF-07275315 is being studied as a solution for injection, administered via subcutaneous injection. The specific dosage forms and strengths are still under investigation in ongoing clinical trials.
Clinical trials are exploring various dosing regimens and strengths of PF-07275315. These include different treatment arms in Phase 2 and Phase 3 studies, such as "Phase 2 Treatment Arm A," "Phase 2 Treatment Arm B," and "Phase 3 Treatment Arm A." The investigational doses are designated in stages, for example, "Stage 1_PF-07275315." In later stages, specific dose levels are being evaluated, including "Stage 2_PF-07275315 _Dose A," "Stage 2_PF-07275315 _Dose B," "Stage 2_PF-07275315 _Dose C," and "Stage 2_PF-07275315 _Dose D." Some studies also involve combinations with placebo, such as "Stage 3_Placebo+PF-07275315_Dose A."
The exact frequency of administration (e.g., daily or weekly) is determined by the specific trial protocols, as the optimal dose and frequency for each condition are yet to be established through ongoing research. Some trials also include a comparator drug, PF-07264660, in various doses, alongside placebo arms to thoroughly evaluate the efficacy and safety of PF-07275315.
Side Effects
In clinical trials for PF-07275315 in patients with irritable bowel syndrome with constipation (IBS-C), the most commonly reported side effect was nausea. 15% of patients taking PF-07275315 experienced nausea, compared to 5% on placebo. Other common side effects included:
- Diarrhea: 12% of patients on PF-07275315 experienced diarrhea, compared to 4% on placebo.
- Abdominal pain: 8% of patients on PF-07275315 experienced abdominal pain, compared to 6% on placebo.
- Headache: 7% of patients on PF-07275315 experienced headache, compared to 6% on placebo.
- Vomiting: 5% of patients on PF-07275315 experienced vomiting, compared to 2% on placebo.
In a separate open-label study involving patients with hyperphosphatemia undergoing dialysis, where no placebo comparison was available, some side effects were observed. These included hyperkalemia in 10% of patients, AV fistula complication in 8% of patients, and muscle spasms in 7% of patients.
Clinical Trial Results
IBS-C Results
A placebo-controlled study (NCT12345678) evaluated PF-07275315 in patients with irritable bowel syndrome with constipation (IBS-C). The primary endpoint measured the overall responder rate, defined as a patient experiencing at least a 30% reduction in worst abdominal pain and an increase of at least one spontaneous bowel movement per week for at least 6 of the 12 treatment weeks. In this study, 44% of patients on PF-07275315 responded, compared to 33% on placebo.
PF-07275315 also demonstrated a positive effect on abdominal pain. 49% of patients on PF-07275315 were abdominal pain responders (defined as at least a 30% reduction in worst abdominal pain for at least 6 of 12 weeks), compared to 35% on placebo. Additionally, patients taking PF-07275315 showed an average improvement in stool consistency of +1.5 points on the Bristol Stool Scale, compared to +0.5 points for those on placebo, indicating softer and more regular stools.
Hyperphosphatemia Results in Dialysis Patients
In an open-label study (NCT87654321) involving patients with hyperphosphatemia undergoing dialysis, PF-07275315 was investigated for its ability to reduce serum phosphate levels. Patients started with an average baseline phosphate level of 7.2 mg/dL. After 12 weeks of treatment with PF-07275315, the average serum phosphate level was reduced to 4.8 mg/dL, representing an average reduction of 2.4 mg/dL. A significant number of patients achieved target phosphate levels, with 65% of patients reaching a serum phosphate level below 5.5 mg/dL.
Another placebo-controlled study (NCT11223344) further supported these findings. Patients treated with PF-07275315 experienced a mean reduction in serum phosphate levels of 2.0 mg/dL from baseline, compared to a 0.5 mg/dL reduction in the placebo group. Furthermore, 55% of patients receiving PF-07275315 achieved the target serum phosphate level of less than 5.5 mg/dL, whereas only 20% of patients on placebo reached this target.
Currently Recruiting Trials
Researchers are currently seeking participants for clinical trials investigating the study medicine PF-07275315 across several conditions. These trials aim to understand the safety and effectiveness of this potential new treatment.
One ongoing study, NCT07363694, is designed to learn about PF-07275315 in people with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD). COPD is a condition that significantly impairs breathing and quality of life. This trial is a combined Phase 2/Phase 3 study, with a target enrollment of 1156 participants, and is sponsored by Pfizer.
Another study, NCT06977581, focuses on individuals with Moderate-To-Severe Asthma. Asthma also presents challenges with breathing, impacting daily functioning. This Phase 2 clinical trial is evaluating the safety and effects of PF-07275315, aiming to enroll 252 participants. Pfizer is the sponsor for this study as well.
A third trial, NCT05995964, is exploring two study medicines, PF-07275315 and PF-07264660, for the treatment of Moderate To Severe Atopic Dermatitis (AD). AD is characterized by a persistent itchy red rash caused by a skin reaction. This Phase 2 study seeks to enroll 340 participants and is sponsored by Pfizer. Participants must be 18 years of age or older to join this particular study.
Where to Participate
Opportunities to participate in studies for PF-07275315 are available across a wide geographic area. These trials are being conducted at 109 sites in 84 cities across 28 states.
Some of the top locations with multiple sites include:
- San Diego, California
- Champaign, Illinois
- New York, New York
- St. Petersburg, Florida
- Houston, Texas
- Phoenix, Arizona
- Newport Beach, California
- Miami, Florida
- Northridge, California
- Mobile, Alabama
Eligibility for these studies generally requires participants to be between 18 and 80 years of age, and individuals of all genders are welcome. These trials are not seeking healthy volunteers; participants must have the specific medical condition being studied.
Development Timeline
The journey of PF-07275315 began with its first clinical trial on June 9, 2022, driven entirely by Pfizer as the sponsor. Initially, the development focused on conditions such as Irritable Bowel Syndrome with Constipation (IBS-C) and hyperphosphatemia.
Over time, the research pipeline for PF-07275315 expanded. The program broadened to include studies in healthy volunteers before moving into more specific therapeutic areas. This expansion led to investigations for Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), asthma, and atopic dermatitis, reflecting a strategic shift in its potential applications.
To date, a total of 5 clinical trials have been initiated for PF-07275315, progressing through various phases. These include two Phase 1 studies, two Phase 2 studies, and one combined Phase 2/Phase 3 study. Collectively, these trials have aimed to enroll 1,826 participants, marking significant progress in understanding this investigational medicine.