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Ampio Pharmaceuticals, Inc. (NYSE American: AMPE) is a pre-revenue stage biotechnology company based in Greenwood Village, Colorado. The company is focused on developing innovative treatments for osteoarthritis through its OA-201 program. This program aims to develop a unique and proprietary small molecule formulation designed to alleviate pain and protect cartilage in patients suffering from osteoarthritis of the knee (OAK) and potentially other joints.
Recently, Ampio faced significant developments, including a 20-to-1 reverse stock split approved by its Board of Directors to address its stock price and meet NYSE American's listing requirements. The reverse stock split took effect in September 2023. Despite these efforts, Ampio decided to voluntarily delist its common stock from NYSE American and deregister its shares to reduce regulatory costs and conserve cash for future operations.
In the clinical field, Ampio has partnered with Ascendia Pharmaceuticals, Inc. to support the development of OA-201. Ascendia will provide comprehensive services ranging from formulation to cGMP manufacturing. Despite promising initial results, recent non-clinical studies failed to demonstrate significant pain reduction benefits, leading to the termination of the OA-201 program in February 2024.
Ampio has also been involved in legal proceedings, including securities fraud class actions and derivative actions, all of which reached settlements in early 2024. The company anticipates that the settlements will be covered by its D&O insurance policy.
The company recently announced that it will delist its common stock and terminate its reporting obligations under the Securities and Exchange Act of 1934, effective April 2024. This decision aims to preserve cash and facilitate an orderly wind down of operations.
For more information, visit the company's website or contact Ampio Pharmaceuticals directly via email at mmartino@ampiopharma.com.
Ampio Pharmaceuticals, Inc. (AMPE) announced positive early results from its Phase I trial of inhaled Ampion for COVID-19 respiratory distress. An independent analysis confirmed that patients receiving Ampion required less oxygen and showed greater clinical improvement than those on standard care. Notably, Ampion also improved all-cause mortality without serious adverse events. The company plans to expand the trial's patient enrollment from 40 to 140 and add more hospitals for faster recruitment. The inhalation method targets lung inflammation directly, with safety as the primary endpoint.
Ampio Pharmaceuticals (AMPE) announced that its Phase I clinical trial for inhalation treatment of COVID-19 using Ampion is currently 55% enrolled. The trial aims to evaluate the efficacy of inhaled Ampion in patients experiencing respiratory distress due to COVID-19. Preliminary feedback from healthcare providers indicates positive outcomes, with no serious drug-related adverse effects reported. The company is optimistic about Ampion's potential, with ongoing studies to assess its impact on the immune response associated with severe COVID-19 symptoms.
Ampio Pharmaceuticals (AMPE) has launched a global clinical trial for intravenous (IV) Ampion treatment targeting COVID-19, focusing on patient safety and efficacy in moderate to severe cases. Ongoing U.S. trials for inhalation treatment are expanding to new hospitals, with no serious adverse events reported. The inhalation trial evaluates the effects of Ampion on respiratory distress, aiming for completion of enrollment by January. Ampio's lead drug, Ampion, has extensive patent protection and is eligible for FDA market exclusivity upon approval.
Ampio Pharmaceuticals (AMPE) announced it received FDA guidance regarding its Phase III clinical trial for osteoarthritis of the knee (OAK) amid COVID-19 disruptions. The trial, AP-013, is under a Special Protocol Assessment (SPA) which allows for streamlined communication with the FDA for a Biologics Licensing Application (BLA). The FDA acknowledged the prevalence of OAK and provided options to allow the continuation of the trial without restarting it, enabling the addition of more patients or use of existing data. Ampio is evaluating these options to proceed with the trial.
Ampio Pharmaceuticals (AMPE) announced the completion of its Phase I clinical trial for IV Ampion treatment in COVID-19 patients and has begun preparations for a global Phase II trial. The Phase I study, involving hospitalized adults, demonstrated that IV Ampion was well-tolerated and met its primary safety endpoints. Promising efficacy was noted, with improved clinical outcomes compared to standard care. Clinical sites in Israel and the U.S. will be part of the upcoming Phase II study, which aims to further explore the treatment's benefits in managing systemic inflammation caused by COVID-19.
Ampio Pharmaceuticals (NYSE American: AMPE) announced two research agreements to explore new clinical indications for its drug, Ampion. The first collaboration involves a leading children's hospital to investigate Ampion's potential in treating rare inflammatory pediatric diseases. The second agreement, with Dr. Andrew Terker from Vanderbilt University, aims to study Ampion's anti-inflammatory effects in acute and chronic kidney diseases. Ampion has multiple FDA-approved administration methods, and no drug-related adverse events have been reported in trials. The company holds a robust patent portfolio and anticipates FDA market exclusivity.
Ampio Pharmaceuticals (NYSE American: AMPE) will hold its annual meeting virtually on December 12, 2020 at 9:00 am MST. Shareholders can join via www.virtualshareholdermeeting.com/AMPE2020 or call 1-877-328-2502. Voting and questions can be submitted through the webcast using a 16-digit control number from the proxy statement. An audio replay will be available on the company’s website within 24 hours of the meeting.
Ampio Pharmaceuticals, Inc. (NYSE: AMPE) announced that its AP-014 Phase I clinical study of inhaled Ampion in COVID-19 patients is progressing to full enrollment. The Safety Monitoring Committee (SMC) confirmed that Ampion was safe and well-tolerated after reviewing initial patient data. The trial will enroll a total of 40 patients, with an emphasis on safety as the primary endpoint. Encouraging preliminary results include a reported improvement in a patient after using nebulized Ampion. The trial aims to confirm Ampion's efficacy amidst ongoing research.
Ampio Pharmaceuticals, Inc. (NYSE American: AMPE) provided updates regarding its clinical trials on November 25, 2020. In the Phase I inhaled Ampion™ trial, the third patient group has completed treatment and awaits Safety Monitoring Committee (SMC) review, allowing for accelerated recruitment for the remaining patients. Additionally, the FDA has accepted an amendment for the Phase III osteoarthritis trial, with a formal response expected by year-end. Ampio's lead drug, Ampion, aims to address inflammatory conditions and has a patent protection extending to 2032.
Ampio Pharmaceuticals, Inc. (NYSE American: AMPE) announced the advancement of the third group in its Phase I clinical study for inhaled Ampion™ aimed at treating COVID-19 respiratory distress. The Safety Monitoring Committee confirmed that Ampion is safe and well-tolerated based on previous treatment groups. The trial, enrolling 40 patients, compares inhaled Ampion to Standard of Care, focusing on safety as its primary endpoint. FDA has cleared multiple administration methods for Ampion, reinforcing its potential in treating various inflammatory diseases. The company is also exploring similar studies overseas.
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