Nebulized Ampion (aspartyl-alanyl diketopiperazine) / Ampio - LARVOL DELTA

A Study of Inhaled Ampion in Adults With Respiratory Distress Due to COVID-19 (clinicaltrials.gov) - P2 | N=200 | Terminated | Sponsor: Ampio Pharmaceuticals. Inc. | N=129 ➔ 200 | Completed ➔ Terminated; The AP-019 study was prematurely terminated by the sponsor after determining that insufficient events were occurring to analyze the primary endpoint.

Enrollment change • Trial termination • Infectious Disease • Novel Coronavirus Disease

A Study of Inhaled Ampion in Adults With Respiratory Distress Due to COVID-19 (clinicaltrials.gov) - P2 | N=129 | Completed | Sponsor: Ampio Pharmaceuticals. Inc. | Recruiting ➔ Completed | N=200 ➔ 129 | Trial completion date: Dec 2021 ➔ Apr 2022 | Trial primary completion date: Oct 2021 ➔ Feb 2022

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

A Study to Evaluate Ampion in Patients With Prolonged Respiratory Symptoms Due to COVID-19 (Long COVID) (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: Ampio Pharmaceuticals. Inc. | Recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease

Study of Nebulized Ampion for the Treatment of Adult COVID-19 Patients With Respiratory Distress (clinicaltrials.gov) - P1 | N=40 | Completed | Sponsor: Ampio Pharmaceuticals. Inc. | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease

Ampio Pharmaceuticals Announces Patient Randomization and Dosing in AP-019 Phase II Study of Inhaled Ampion in COVID-19 Respiratory Distress (PRNewswire) - "Ampio Pharmaceuticals...announced randomization and dosing of patients in its multi-center AP-019 Phase II clinical trial, using inhaled Ampion™ in the treatment of respiratory distress due to COVID-19, is underway....The company initiated the AP-019, double-blind, placebo-controlled Phase II trial, utilizing inhaled Ampion following the strong top-line results achieved from its AP-014 Phase I trial."

Trial status • Infectious Disease • Novel Coronavirus Disease

Ampio Pharmaceuticals Receives Approval to Expand Enrollment of its AP-019 Phase II Study to India (PRNewswire) - "Ampio Pharmaceuticals...has received regulatory approval to expand enrollment of its AP-019 Phase II study to India. The study will utilize inhaled Ampion™ to treat those suffering from respiratory distress due to COVID-19....The company initiated the AP-019, double-blind, placebo-controlled Phase II trial, utilizing inhaled Ampion following the strong top-line results achieved from its AP-014 Phase I trial....The Company has a made a strategic decision to discontinue the AP-019 study efforts in Israel and reallocate and focus these resources to select regions of India and other potential select territories outside the United States..."

Trial status • Infectious Disease • Novel Coronavirus Disease

Ampio Pharmaceuticals to Present at the 2021 International Society for Pharmaceutical Engineers Annual Meeting and Expo (PRNewswire) - "Ampio Pharmaceuticals...announced details on the Company's poster presentation...being given at the 2021 International Society for Pharmaceutical Engineers (ISPE) Annual Meeting and Expo in Boston, Massachusetts from November 1st to 3rd, 2021....The presentation highlights Ampio's innovative work which has significantly and rapidly expanded the capabilities of its wholly owned, automated drug manufacturing facility that was initially focused on producing 4 cc vials of its platform immunomodulatory drug Ampion™ for intra-articular injections into patients with osteoarthritis of the knee. In less than 4 months, the manufacturing facility was reprogrammed to manufacture Ampion products packaged to be clinically administered in doses more than ten times larger, either intravenously (IV) to, or inhaled by, patients suffering from acute respiratory distress due to COVID-19."

Review • Immunology • Infectious Disease • Novel Coronavirus Disease

Ampio Pharmaceuticals to Present Poster at the International Society for Aerosols in Medicine (ISAM) 23rd International Congress (PRNewswire) - P1, N=40; NCT04606784; Sponsor: Ampio Pharmaceuticals. Inc.; "Ampio Pharmaceuticals...announced details on the company's poster presentation...being given at the 23rd International Congress of the International Society for Aerosols in Medicine (ISAM), in Boise, Idaho, May 22 to 26, 2021....The 23rd ISAM Congress is being held as a hybrid event....Ampio's poster is based on the Company's preparations for its recently completed AP-014 Phase I clinical trial...The study showed inhaled Ampion reduced all-cause mortality in COVID-19 respiratory distress by 78% over the Standard of Care (SOC) alone....The FDA identified a need to assess the no-observed-adverse-effect level (NOAEL) in animals with Ampion via inhalation as the intended route of administration. Ampio designed a study with FDA feedback to assess the potential local toxicity to the lung and other respiratory tissues at a range of inhalation doses."

P1 data • Preclinical • Infectious Disease • Novel Coronavirus Disease

Ampio Pharmaceuticals Receives Investigational Review Board Approval for its Phase I Long COVID-19 Trial (AP-018) (PRNewswire) - "Ampio Pharmaceuticals...has received Investigational Review Board (IRB) approval to commence enrollment in its AP-018 Phase I study using inhaled Ampion™ with patients exhibiting prolonged respiratory COVID-19 symptoms, known as long (or long-haul) COVID, or Post-Acute Sequelae of SARS-CoV-2....The Phase 1 study...is to evaluate the safety and efficacy of inhaled Ampion in adults with prolonged respiratory complications after COVID-19 infection. Thirty (30) participants with a confirmed, symptomatic COVID-19 diagnosis who continue to experience at least two COVID-19 respiratory symptoms will be randomized in one of two groups, active or placebo control."

Review • Infectious Disease • Novel Coronavirus Disease

A Study to Evaluate Ampion in Patients With Prolonged Respiratory Symptoms Due to COVID-19 (Long COVID) (clinicaltrials.gov) - P1; N=30; Recruiting; Sponsor: Ampio Pharmaceuticals. Inc.

Clinical • New P1 trial • Infectious Disease • Novel Coronavirus Disease • PCR

Ampio Pharmaceuticals, Inc. Reports First Quarter 2021 Financial Results and Provides Business Update (PRNewswire) - "Initiated two Phase II trials utilizing Ampion in COVID-19; in an inhaled form for lung inflammation and intravenously; could lead to application for Emergency Use Authorization; New Study in COVID-19 'Long Haulers' Initiated; Double-blind, placebo-controlled Phase II trials utilizing (i) inhaled Ampion for patients impacted from COVID-19 induced respiratory distress and (ii) intravenously delivered Ampion for COVID-19 patients, will begin enrollment in the U.S. during the second quarter of 2021....Phase I Long-COVID trial is expected to commence enrolling patients in the U.S. during the second quarter of 2021."

Trial status • Infectious Disease • Novel Coronavirus Disease

Ampio Pharmaceuticals Provides Updates on Clinical Programs for Ampion in Osteoarthritis and COVID-19 (PRNewswire) - "Separately, the Phase I study using Ampion to address the respiratory symptoms experienced by COVID-19 'Long Haulers' is awaiting Investigational Review Board (IRB) approval and is expected to commence enrollment shortly."

New P1 trial • Infectious Disease • Novel Coronavirus Disease

A Study of Inhaled Ampion in Adults With Respiratory Distress Due to COVID-19 (clinicaltrials.gov) - P2; N=200; Recruiting; Sponsor: Ampio Pharmaceuticals. Inc.

Clinical • New P2 trial • Infectious Disease • Novel Coronavirus Disease

Study of Nebulized Ampion for the Treatment of Adult COVID-19 Patients With Respiratory Distress (clinicaltrials.gov) - P1; N=40; Active, not recruiting; Sponsor: Ampio Pharmaceuticals. Inc.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Infectious Disease • Novel Coronavirus Disease

Ampio Pharmaceuticals Details Early Positive Results for Inhaled Ampion in COVID-19 Respiratory Distress (PRNewswire) - P1, N=40; NCT04606784; Sponsor: Ampio Pharmaceuticals. Inc.; "Ampion demonstrated an improvement in all-cause mortality in COVID-19 patients...A lower all-cause mortality rate of 8% is observed for the Ampion treatment group, compared to 21% in standard of care alone; The average hospital length of stay was 7 days for the Ampion group compared to 11 days...Patients who received Ampion required less oxygen...Ampio also provided details on its forthcoming Phase I clinical trial utilizing inhaled Ampion with patients exhibiting 'long hauler' COVID-19 symptoms...The trial design will deal specifically with respiratory distress-related symptoms and will involve an "at home" treatment, where patients will receive a nebulizer and a five-day supply of inhaled Ampion. The trial protocol is currently being finalized, with commencement of the study expected by mid-Q2 2021."

New P1 trial • P1 data • Infectious Disease • Novel Coronavirus Disease

Ampio Pharmaceuticals, Inc. Reports Fourth Quarter 2020 Financial Results and Provides Business Update (PRNewswire) - "'The FDA has recently responded to our requests to expand our IV and Inhalation Covid-19 studies, utilizing Ampion, by recommending we conduct a randomized, double-blinded, placebo-controlled Phase II trial in each. They also indicated that their recommended trial design for both will allow for an effective and efficient review of data results, determine the safety and statistical significance and effectiveness of Ampion in comparison to Standard of Care...and, consequently, Ampion may be considered for emergency use authorization (EUA).'"

FDA event • New P2 trial • Infectious Disease • Novel Coronavirus Disease

Ampio (AMPE) Brings New Hospitals Online in Trial for Inhalation Treatment of COVID-19 with Ampion (Streetinsider.com) - "Ampio Pharmaceuticals, Inc....announced the addition of two new study sites to further the expansion of its ongoing U.S. Phase I clinical trial for inhalation treatment of COVID-19 with Ampion ('AP-014')....In this trial, Ampion is administered to patients by inhalation...Trial will enroll 140 patients, randomized 1 to 1, inhaled Ampion versus Standard of Care..."

Trial status • Infectious Disease • Novel Coronavirus Disease

Ampio Announces Early Positive Data in Phase 1 Trial of Inhaled Ampion in COVID-19 Respiratory Distress (PRNewswire) - P1, N=40; NCT04606784; Sponsor: Ampio Pharmaceuticals. Inc.; "An independent statistical analysis revealed patients administered Ampion needed less oxygen and showed greater clinical improvement than those receiving the standard of care for COVID-19 respiratory complications. Ampion improved all-cause mortality in COVID-19 patients with respiratory distress compared to standard of care, and there have been no drug-related serious adverse events. On this positive data, Ampio plans to increase the number of patients in the trial from 40 to 140 and has added additional hospitals as study sites....The analysis also showed Ampion improved all-cause mortality in COVID-19 patients with respiratory distress compared to standard of care patients."

P1 data • Trial status • Infectious Disease • Novel Coronavirus Disease

Ampio Provides Update on Clinical Trials for Ampion Treatment of COVID-19 Patients (PRNewswire) - "Ampio Pharmaceuticals, Inc....today announced an update on the launch of a new global clinical trial for intravenous ('IV') treatment of COVID-19 with Ampion and provided updates on its ongoing U.S. trial for inhalation treatment of COVID-19....A global study has been initiated in Israel and the U.S. with the focus on patient safety and efficacy....A Phase I clinical trial is ongoing, with the primary focus to evaluate the impact of inhaled Ampion treatment in patients with respiratory distress due to COVID-19....Of note, there have been no drug-related SAEs to date in the inhaled clinical trial."

Cytokine storm • Trial status • Infectious Disease • Novel Coronavirus Disease

Ampio’s Phase I Study For Inhaled Ampion Advances To Completing Enrollment Of COVID-19 Patients With Respiratory Distress (PRNewswire) - "Ampio Pharmaceuticals, Inc....announced today that its AP-014 Phase I inhaled Ampion™ clinical study in COVID-19 patients is proceeding to full open enrollment following clearance by the Safety Monitoring Committee (SMC), which found Ampion to be safe and well-tolerated after reviewing results from the first three treatment groups. The trial can now accelerate to complete enrollment of the remaining 34 patients at the speed of recruitment....'The enrollment of patients will proceed quickly, perhaps doubling the number of patients enrolled by the end of today.'...In related news, the Journal of Translational Medicine this week published a peer-reviewed paper on the method of action of Ampion, entitled 'LMWF5A suppresses cytokine release by modulating select inflammatory transcription factor activity in stimulated PBMC,'..."

Cytokine release syndrome • Enrollment status • P1 data • Novel Coronavirus Disease

Study of Nebulized Ampion for the Treatment of Adult COVID-19 Patients With Respiratory Distress (clinicaltrials.gov) - P1; N=40; Recruiting; Sponsor: Ampio Pharmaceuticals. Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Infectious Disease • Novel Coronavirus Disease

Ampio Updates Regulatory and Clinical Trial Events (PRNewswire) - "In the Phase I inhaled Ampion™ clinical trial (AP-014), the third of three initial safety groups of patients have completed their five days of treatment and three days of follow up for Safety Monitoring Committee (SMC) review (as inhalation is a new delivery method of Ampion cleared for clinical use by the FDA). Once the SMC provides confirmation regarding no safety concerns for this third group, the trial will accelerate to complete the remaining thirty-four patients at the speed of recruitment with additional hospital groups added as required to support enrollment."

Trial status • Infectious Disease • Novel Coronavirus Disease

Ampio's Phase I Study for Inhaled Ampion Advances to 3rd Group of COVID-19 Patients with Respiratory Distress (PRNewswire) - "Ampio Pharmaceuticals, Inc....announced today that the third group in the Phase I inhaled Ampion™ clinical study is being treated following clearance by the Safety Monitoring Committee (SMC) who found Ampion to be safe and well-tolerated after reviewing the results from the first and second treatment groups."

DSMB • Trial status • Infectious Disease • Novel Coronavirus Disease

Ampio's Phase I Study For Inhaled Ampion Advances To 2nd Group Of COVID-19 Patients With Respiratory Distress (PRNewswire) - "Ampio Pharmaceuticals, Inc....announced today that the second group in the Phase I inhaled Ampion™ clinical study is being treated following clearance by the Safety Monitoring Committee (SMC) who found Ampion to be safe and well-tolerated after reviewing the results from the first treatment group."

DSMB • Trial status • Infectious Disease • Novel Coronavirus Disease

Ampio Begins Phase 1 Clinical Trial of Inhaled Ampion For COVID-19 Patients With Respiratory Distress (PRNewswire) - "Ampio Pharmaceuticals, Inc....announced today the Company has begun recruiting and enrolling patients in a Phase I multi-center, randomized, controlled trial....Dosing of patients will begin at Penrose Hospital in Colorado....Ampion will be administered to COVID-19 patients by inhalation....This US study will enroll 40 patients, randomized 1 to 1, Ampion in addition to SOC versus SOC alone. Each patient in the treatment arm will inhale 8 mL doses of Ampion four (4) times a day for five (5) days....The first three patients inhaling Ampion will be assessed by a Safety Monitoring Committee for an additional three days after the 5 day treatment period."

Enrollment status • Infectious Disease • Novel Coronavirus Disease