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

Study of Intravenous Ampion in Adult COVID-19 Patients Requiring Supplemental Oxygen (clinicaltrials.gov) - P2 | N=36 | Terminated | Sponsor: Ampio Pharmaceuticals. Inc. | Completed ➔ Terminated; The AP-017 study was prematurely terminated by the sponsor after an interim analysis.

Trial termination • Infectious Disease • Novel Coronavirus Disease

Study of Intravenous Ampion in Adult COVID-19 Patients Requiring Supplemental Oxygen (clinicaltrials.gov) - P2 | N=36 | Completed | Sponsor: Ampio Pharmaceuticals. Inc. | Recruiting ➔ Completed | N=200 ➔ 36 | Trial completion date: Nov 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

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, 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

Ampio Pharmaceuticals’ Study Shows Ampion Inhibits a Key Inflammatory Pathway in COVID-19 and Lupus Nephritis (PRNewswire) - "Ampio Pharmaceuticals...announced the results of a pre-clinical study demonstrating that Ampion inhibits an important pro-inflammatory pathway in the types of immune cells implicated in COVID-19 and Lupus Nephritis. The aim of the investigation was to evaluate the ability of Ampion to suppress TLR7 signaling and, thereby, reduce the pro-inflammatory chemokine, CXCL10....'Ampion reduced CXCL10 up to 92 percent compared to a saline solution (p<0.05). This result also implies a role for Ampion in inhibiting the upregulated TLR7 signaling shown in the devastating kidney complication of systemic lupus erythematous, lupus nephritis, for which no specific treatment is available'."

Preclinical • Immunology • Infectious Disease • Lupus • Lupus Nephritis • Novel Coronavirus Disease • Systemic Lupus Erythematosus

Study of Intravenous Ampion in Adult COVID-19 Patients Requiring Supplemental Oxygen (clinicaltrials.gov) - P2; N=200; Recruiting; Sponsor: Ampio Pharmaceuticals. Inc.

New P2 trial • 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 Pharmaceuticals Ongoing Phase I Clinical Trial for Inhalation Treatment of COVID-19 with Ampion is 55% Enrolled (PRNewswire) - "Ampio Pharmaceuticals, Inc....today announced its ongoing U.S. Phase I clinical trial for inhalation treatment of COVID-19 with Ampion (AP-014) is 55% enrolled. The Phase I clinical trial is ongoing...'Our experience using inhaled Ampion to treat patients with COVID-19 continues to trend positively showing no serious drug-related adverse effects...Feedback from the Safety Monitoring Committee (SMC), analyzing any safety concerns related to inhaled Ampion, is expected later this month....In vitro, Ampion interrupts the hyper-active immune response, known as the cytokine storm...The benefit of this effect from Ampion is currently being studied in multiple human clinical trials."

Cytokine storm • DSMB • Enrollment status • Novel Coronavirus Disease

Study of Ampion for the Treatment of Adult COVID-19 Patients Requiring Oxygen Supplementation (clinicaltrials.gov) - P1; N=10; Completed; Sponsor: Ampio Pharmaceuticals. Inc.; Active, not recruiting ➔ Completed

Clinical • Trial completion • 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

Ampion Demonstrates Safety In COVID-19 Patients And Initiates Global Clinical Trial For Intravenous Ampion (PRNewswire) - P1, N=10; NCT04456452; Sponsor: Ampio Pharmaceuticals. Inc.; "Ampio Pharmaceuticals, Inc....announced today it has completed its Phase I clinical trial and has initiated the first steps for a global Phase II clinical trial...Safety Monitoring Committee ('SMC') found the IV treatment of Ampion to be safe and well-tolerated for 90-days following treatment; The study met its primary safety endpoint after 5 days of IV Ampion treatment and again after 3 months...The study showed promising efficacy with the IV Ampion treatment group seeing stronger clinical improvement...IV Ampion treatment in COVID-19 patients will be further explored using two treatment groups in a larger Phase II study...Clinical sites in Israel will be used concurrently with sites in the United States..."

Cytokine storm • DSMB • New P2 trial • P1 data • Trial completion • Infectious Disease • Novel Coronavirus Disease

Ampio Presents at Roth Capital Partners 2020 MedTech Innovation Forum Focusing on COVID-19 Clinical Trial Activities (PRNewswire) - P1, N=10; NCT04456452; Sponsor: Ampio Pharmaceuticals. Inc.; "Ampio Pharmaceuticals, Inc....announced today that the Company will present at the 2020 MedTech Innovation Forum hosted by Roth Capital Partners on Wednesday, October 28, 2020....There were no drug related adverse events for a period of 5 days....Addition of Ampion to the SOC resulted in better average outcomes (reduction in 3 points for Ampion+ SOC versus 1.5 and 2.25 points for SOC and SOC+remdesivir, respectively). Average scores as measured by the Ordinal Scale at the time of discharge from the hospital were also better for Ampion+SOC compared to the other groups..."

P1 data • Infectious Disease • Novel Coronavirus Disease

Ampio Reports Positive Results for Ampion Treatment in COVID-19 Patients (PRNewswire) - P1, N=10; NCT04456452; Sponsor: Ampio Pharmaceuticals. Inc.; "Ampio Pharmaceuticals, Inc....today announced positive results in early trial for intravenous ('IV') AmpionTM treatment for COVID-19 patients....The study met its primary endpoint for the safety and tolerability of IV Ampion treatment, with no remarkable difference in the incidence, frequency, and severity of adverse events between IV Ampion and standard of care. All patients treated with IV Ampion improved after treatment. At hospital discharge, the IV Ampion treatment group had a stronger clinical improvement than the COVID standard of care control group..."

P1 data • Infectious Disease • Novel Coronavirus Disease

Ampio Announces Enrollment Completion for Intravenous (“IV“) COVID-19 Clinical Trial & Provides Update on Osteoarthritis of the Knee (“OAK“) Clinical Trial (PRNewswire) - "Enrollment has been completed for the AmpionTM Phase I US based clinical trial for IV treatment of COVID-19 patients requiring supplemental oxygen. The final results from the 5-day treatment will be reported when the Safety Monitoring Committee ('SMC') and the Principal Investigator complete their evaluations which we expect should occur within the next week."

Enrollment closed • P1 data • Novel Coronavirus Disease

Ampio Provides Update on COVID-19 Clinical Trial Activities (PRNewswire) - P1, N=10; NCT04456452; Sponsor: Ampio Pharmaceuticals. Inc.; "The initial safety assessments are complete and the trial is cleared to enroll the remaining patients....The results were reviewed by an independent Safety Monitoring Committee...who found Ampion to be safe and well-tolerated, and who authorized the trial to move to completion....The FDA requested comprehensive tests on the safety of nebulized Ampion at various doses. The results...found no evidence of toxicity in preclinical trials, even at extreme doses, and this extensive data has been submitted to the FDA."

DSMB • P1 data • Preclinical • Infectious Disease • Novel Coronavirus Disease

Ampio Starts Patient Enrollment in its Ampion COVID-19 Program (BioSpace) - "Patients are being dosed in a Phase 1 United States based clinical trial evaluating a 5-day intravenous ('IV') AmpionTM treatment for COVID-19 patients requiring supplemental oxygen. The primary endpoint for this randomized, controlled study will evaluate the safety and tolerability of IV Ampion treatment in adult COVID-19 patients requiring oxygen supplementation."

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