Candidate: Ampion™
Type: Low molecular weight fraction of human serum albumin (HSA), and the company’s lead drug, in Phase III development for osteoarthritis of the knee and Phase I for osteoarthritis of the hand. The primary constituent ingredient is aspartyl-alanyl diketopiperazine (DA-DKP), an endogenous immunomodulatory molecule derived from the N-terminus of HSA
2021 Status: AP-019 Trial Launches—in Ampio on June 25 announced it was underway with randomization and dosing of patients in its multi-center Phase II AP-019 trial (NCT04868890) assessing inhaled Ampion™ in the treatment of respiratory distress due to COVID-19. The up-to-200 participant study’s primary endpoint is the efficacy of Ampion on all cause mortality compared to placebo at Day 28. Ampio has also received FDA approval to expand AP-019 to India, due to its dramatic surge in COVID-19 cases.
Ampio said May 10 that it received Investigational Review Board (IRB) approval to begin enrollment in its AP-018 Phase I trial (NCT04880161) using 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 trial is designed to evaluate the safety and efficacy of inhaled Ampion in adults with prolonged respiratory complications after COVID-19 infection. Thirty 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. Both groups will be given a nebulizer to use at home for five days. Participants will be followed for 60 days after treatment.
The primary endpoint of the study is the incidence and severity of adverse events (AEs) and serious adverse events (SAEs) from baseline to Day 28 and Day 60. The trial will be led by Principal Investigator Michael J. Barber, MD, PhD, Director of Medical, Cardiovascular and Intravenous Nutritional Services for the Strata Integrated Wellness Spa.
On April 27, Ampio said Ampion showed a 78% improvement in all-cause mortality compared to standard-of-care (SoC)—5% vs. 24%–in the Phase I AP-014 trial (NCT04606784) assessing an inhaled form of the drug in treating respiratory distress due to COVID-19. The result was better than the 62% improvement reported by the company in preliminary results from the study back in March (8% for Ampion, 21% for SoC).
Ampion also said the average hospital length of stay among AP-014 patients was 4 days less for the Ampion group compared to the patients receiving SoC. By day 5, 89% of patients who received Ampion were stable or had improvement compared to 77% of patients who received SoC.
The company said it can begin enrolling patients in the U.S. after obtaining Investigational Review Board (IRB) approvals for two planned Phase II trials of Ampion: One evaluating inhaled Ampion for COVID-19 respiratory distress, the other assessing intravenous Ampion for more systemic symptoms of COVID-19. The company is also pursuing IRB approval for a Phase I study in using Ampion to address the respiratory symptoms experienced by COVID-19 long haulers.
Ampio on April 6 announced results of a preclinical study showing that Ampion inhibited a pro-inflammatory pathway in the types of immune cells implicated in COVID-19. The study was designed to evaluate Ampion’s ability to suppress TRL7 signaling, and thus reduce the pro-inflammatory chemokine CXCL10. Ampion was shown to reduce CXCL10 up to 92% compared to a saline solution—a result that according to Ampion implies a role for Ampion in inhibiting the upregulated TLR7 signaling shown in lupus nephritis.
Ampio on February 1 announced early positive data from its ongoing U.S. Phase I AP-014 trial comparing its namesake inhaled drug Ampion versus standard of care for patients with COVID-19 respiratory distress. Patients administered Ampion needed less oxygen and showed greater clinical improvement than those receiving the standard of care for COVID-19 respiratory complications, Ampio said, citing an independent statistical analysis of data not disclosed in a company announcement of the outcome.
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, Ampio said. Based on the positive data, Ampio said, it plans to increase the number of patients in the trial from 40 to 140 and has added additional hospitals as study sites.
Ampio said January 14 that its ongoing U.S. Phase I trial assessing its namesake drug Ampion (formerly AP-014) as an inhalation treatment of patients with respiratory distress due to COVID-19 was 55% enrolled. As of that date, no patients in the study showed drug-related serious adverse events.
2020 Status: On November 25, Ampio said that in its Phase I AP-014 trial (NCT04606784) evaluating Ampion in COVID-19 patients requiring supplemental oxygen, 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—required since 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 the third group, the trial will accelerate to complete the remaining 34 patients at the speed of recruitment, with additional hospital groups added as required to support enrollment, Ampio said.
In May, Ampio said it filed IND applications for Ampion with the FDA, and has maintained ongoing dialogue with the agency regarding the company’s development of treatment options that include inhalation and intravenous applications for COVID-19 affected patients. According to Ampio, years of in-vitro studies on cell cultures have confirmed that Ampion’s mechanism of action may be suitable for the treatment of inflammatory conditions, such as acute respiratory distress syndrome (ARDS) and the cytokine storm associated with COVID-19.
COVID-19: 300 Candidates and Counting
To navigate through the >300 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:
● FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.
● DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data
● KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.
● TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.
GEN has also tagged the most common treatment types:
● ANTIVIRAL
● VAX
● ANTIBODY
● RNA
