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Details:
Ampion (Aspartyl-alanyl-diketopiperazine) is a novel biologic drug containing a blood-derived cyclized peptide and small molecules that target multiple pathways in the innate immune response characteristic of inflammatory disease.
Lead Product(s): Aspartyl-alanyl-diketopiperazine
Therapeutic Area: Musculoskeletal Product Name: Ampion
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 16, 2022
Details:
Ampion, a novel biologic drug containing a blood-derived cyclized peptide, demonstrated a statistically significant reduction in pain and trended favorably toward improvement in function versus saline control, retained more than 85% power to evaluate improvements in pain.
Lead Product(s): Aspartyl-alanyl-diketopiperazine
Therapeutic Area: Rheumatology Product Name: Ampion
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 02, 2022
Details:
AP-019 utilizing inhaled Ampion™ to treat those suffering from respiratory distress due to COVID-19. Ampion is immunomodulatory agent with anti-inflammatory effects, Ampion interrupts the hyperactive immune response associated with COVID-19.
Lead Product(s): Aspartyl-alanyl-diketopiperazine
Therapeutic Area: Infections and Infectious Diseases Product Name: Ampion
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 21, 2021
Details:
Ampio’s poster highlights the Company’s recently completed AP-014 Phase I clinical trial utilizing an inhaled form of Ampio’s drug, Ampion, for treatment of respiratory distress in patients as a result of COVID-19.
Lead Product(s): Aspartyl-alanyl-diketopiperazine
Therapeutic Area: Infections and Infectious Diseases Product Name: Ampion
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 27, 2021
Details:
The study will utilize inhaled Ampion™ to treat those suffering from respiratory distress due to COVID-19. Top-line results also showed that Ampion reduced all-cause mortality in COVID-19 respiratory distress by 78% for COVID-19 respiratory distress.
Lead Product(s): Aspartyl-alanyl-diketopiperazine
Therapeutic Area: Infections and Infectious Diseases Product Name: Ampion
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 15, 2021
Details:
AP-014 Phase I clinical trial utilizing an inhaled form of Ampio's drug, Ampion™, in treating respiratory distress in patients as a result of COVID-19.
Lead Product(s): Aspartyl-alanyl-diketopiperazine
Therapeutic Area: Infections and Infectious Diseases Product Name: Ampion
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 21, 2021
Details:
Ampio has received Investigational Review Board (IRB) approval to conduct a Phase 1 study that will evaluate the safety and efficacy of Ampion in patients with prolonged respiratory symptoms due to COVID-19 (Long-COVID).
Lead Product(s): Aspartyl-alanyl-diketopiperazine
Therapeutic Area: Infections and Infectious Diseases Product Name: Ampion
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 10, 2021
Details:
Phase I trial of inhaled Ampion in COVID-19 respiratory distress meets primary endpoint, achieves better reduction in all-cause mortality than in interim analysis.
Lead Product(s): Aspartyl-alanyl-diketopiperazine
Therapeutic Area: Musculoskeletal Product Name: Ampion
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 27, 2021
Details:
Laboratory results suggest Ampion's suitability for addressing kidney diseases and provides further evidence it is a platform biologic for treatment of inflammatory and autoimmune diseases.
Lead Product(s): Aspartyl-alanyl-diketopiperazine
Therapeutic Area: Infections and Infectious Diseases Product Name: Ampion
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 06, 2021
Details:
Ampio recently completed enrollment in its AP-014 Phase I clinical trial utilizing inhaled Ampion in treating respiratory distress in patients as a result of COVID-19.
Lead Product(s): Aspartyl-alanyl-diketopiperazine
Therapeutic Area: Infections and Infectious Diseases Product Name: Ampion
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 29, 2021
Details:
The preliminary results from the AP-014 Phase I trial indicated that Ampion showed an improvement in all-cause mortality in Covid-19-infected patients as against standard of care (SOC).
Lead Product(s): Aspartyl-alanyl-diketopiperazine
Therapeutic Area: Infections and Infectious Diseases Product Name: Ampion
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 16, 2021
Details:
Safety is the primary end point of the AP-014 study, with various measurements indicative of efficacy as secondary endpoints. Inhalation is a new method for the administration of Ampion which has been cleared for clinical use by the FDA.
Lead Product(s): Aspartyl-alanyl-diketopiperazine
Therapeutic Area: Infections and Infectious Diseases Product Name: Ampion
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 23, 2021
Details:
According to an independent statistical analysis, patients who received Ampion required less oxygen and demonstrated better clinical improvement than people given standard of care for Covid-19 respiratory complications.
Lead Product(s): Aspartyl-alanyl-diketopiperazine
Therapeutic Area: Infections and Infectious Diseases Product Name: Ampion
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 01, 2021
Details:
The 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.
Lead Product(s): Aspartyl-alanyl-diketopiperazine
Therapeutic Area: Infections and Infectious Diseases Product Name: Ampion
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 14, 2021
Details:
Ampion Pharmaceuticals announced today that it has completed its Phase I clinical trial and has initiated the first steps for a global Phase II clinical trial for intravenous (“IV”) Ampion treatment in COVID-19 patients.
Lead Product(s): Aspartyl-alanyl-diketopiperazine
Therapeutic Area: Infections and Infectious Diseases Product Name: Ampion
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 17, 2020
Details:
Under the collaboration both parties will work together and conduct exploratory research to determine whether the anti-inflammatory and signaling pathways of Ampioncould play a role in the treatment of certain rare Inflammatory Pediatric Diseases.
Lead Product(s): Aspartyl-alanyl-diketopiperazine
Therapeutic Area: Immunology Product Name: Ampion
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration December 10, 2020
Details:
Ampio's AP-014 Phase I inhaled Ampion trial in COVID-19 patients is proceeding to full open enrollment following clearance by the Safety Monitoring Committee, which found Ampion to be safe and well-tolerated after reviewing results from the first three treatment groups.
Lead Product(s): Aspartyl-alanyl-diketopiperazine
Therapeutic Area: Infections and Infectious Diseases Product Name: Ampion
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 02, 2020
Details:
In the Phase I AP-014 trial, the third of three initial safety groups of patients have completed their five days of treatment and three days of follow up for SMC review. Amendment to the OAK Phase III clinical trial (AP-013), in line with an agreement with FDA, is on hold.
Lead Product(s): Aspartyl-alanyl-diketopiperazine
Therapeutic Area: Infections and Infectious Diseases Product Name: Ampion
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 25, 2020
Details:
Ampion is being administered to patients by inhalation, allowing the drug to directly target and stop inflammation in the lungs, using a hand-held nebulizer for early COVID-19 patients and face mask and mechanical ventilation if their disease state is more severe.
Lead Product(s): Aspartyl-alanyl-diketopiperazine
Therapeutic Area: Infections and Infectious Diseases Product Name: Ampion
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 17, 2020
Details:
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.
Lead Product(s): Aspartyl-alanyl-diketopiperazine
Therapeutic Area: Infections and Infectious Diseases Product Name: Ampion
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 10, 2020
Details:
Company has begun enrolling patients in a Ph 1 multi-center, randomized, controlled trial for a total of 40 patients that will assess the safety & efficacy of inhaled Ampion addition to standard of care for COVID-19 infected patients hospitalized for respiratory distress.
Lead Product(s): Aspartyl-alanyl-diketopiperazine
Therapeutic Area: Infections and Infectious Diseases Product Name: Ampion
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 28, 2020
Details:
The approved clinical trial will study the effects of inhaled Ampion while emphasizing early intervention treatment throughout the clinical progression of COVID-19 infection.
Lead Product(s): Aspartyl-alanyl-diketopiperazine
Therapeutic Area: Infections and Infectious Diseases Product Name: Ampion
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 21, 2020
Details:
Ampion-treated patients showed improvement from severe disease/hospitalization to uninfected/ambulatory on the ordinal scale.
Lead Product(s): Aspartyl-alanyl-diketopiperazine
Therapeutic Area: Infections and Infectious Diseases Product Name: Ampion
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 09, 2020
Details:
Enrollment has been completed for the AmpionTM Phase I US based clinical trial for IV treatment of COVID-19 patients requiring supplemental oxygen.
Lead Product(s): Aspartyl-alanyl-diketopiperazine
Therapeutic Area: Infections and Infectious Diseases Product Name: Ampion
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 04, 2020
Details:
The initial safety assessments are complete and the trial is cleared to enroll the remaining patients for the Phase I US based clinical trial evaluating a 5-day IV AmpionTM treatment for COVID-19 patients requiring supplemental oxygen.
Lead Product(s): Aspartyl-alanyl-diketopiperazine
Therapeutic Area: Infections and Infectious Diseases Product Name: Ampion
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 19, 2020
Details:
This newly described syndrome in children resembles Kawasaki Disease and exhibits many signs, symptoms and pathology that could be treated by intravenous AmpionTM either alone or in combination with intravenous immunoglobulins.
Lead Product(s): Aspartyl-alanyl-diketopiperazine
Therapeutic Area: Infections and Infectious Diseases Product Name: Ampion
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 20, 2020
Details:
Ampio has filed Investigative New Drug ("IND") applications for Ampion™ with the FDA and has maintained ongoing dialog with the FDA regarding the Company's development of treatment options which includes inhalation and intravenous applications for COVID-19 affected patients.
Lead Product(s): Aspartyl-alanyl-diketopiperazine
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 22, 2020
Details:
Ampio has submitted an Investigational New Drug Application to the FDA for the use of nebulized Ampion to treat COVID-19 patients with acute respiratory distress syndrome.
Lead Product(s): Aspartyl-alanyl-diketopiperazine
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 11, 2020
Details:
Ampio is preparing an expanded access FDA protocol to study potential benefit of nebulized treatment with Ampion in SARS-Cov-2 induced ADRS.
Lead Product(s): Aspartyl-alanyl-diketopiperazine
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 24, 2020
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