A Randomized, Double-Blinded, Placebo-Controlled Phase I Study to Evaluate the Safety and Efficacy of Ampion in Patients With Prolonged Respiratory Symptoms Due to COVID-19 (Long COVID)

This is a phase I study to evaluate the safety and efficacy of inhaled Ampion on patients with prolonged respiratory symptoms due to COVID-19 (Long COVID).

Start Date26 Jul 2021

Sponsor / Collaborator

Ampio Pharmaceuticals, Inc.

NCT04839965 / TerminatedPhase 2

A Randomized, Double-Blinded, Placebo Controlled Phase II Study to Evaluate the Safety and Efficacy of IV Ampion in Adult COVID-19 Patients Requiring Oxygen Supplementation

This is a Phase 2 randomized study to evaluate the safety and efficacy of IV Ampion in improving the clinical course and outcomes of adult COVID-19 patients requiring supplemental oxygen.

Start Date05 Jul 2021

Sponsor / Collaborator

Ampio Pharmaceuticals, Inc.

NCT04868890 / TerminatedPhase 2

A Randomized, Double-Blinded, Placebo-Controlled Phase II Study to Evaluate the Safety and Efficacy of Inhaled Ampion in Adults With Respiratory Distress Due to COVID-19

This is phase II study to evaluate the safety and efficacy of inhaled Ampion in adults with respiratory distress due to COVID-19

Start Date22 Jun 2021

Sponsor / Collaborator

Ampio Pharmaceuticals, Inc.

100 Clinical Results associated with Aspartyl-alanyl-diketopiperazine

100 Translational Medicine associated with Aspartyl-alanyl-diketopiperazine

100 Patents (Medical) associated with Aspartyl-alanyl-diketopiperazine

Literatures (Medical) associated with Aspartyl-alanyl-diketopiperazine

01 Feb 2024·Journal of dairy science

Effect of dipotassium phosphate addition and heat on proteins and minerals in milk protein beverages

Article

Author: Barbano, David M ; Pranata, Joice ; Drake, MaryAnne ; Hoyt, Hayden

Our objective was to determine the effects of dipotassium phosphate (DKP) addition, heat treatments (no heat, high temperature, short time [HTST]: 72°C for 15 s, and direct steam injection UHT: 142°C for 2.3 s), and storage time on the soluble protein composition and mineral (P, Ca, K) concentration of the aqueous phase around casein micelles in 7.5% milk protein-based beverages made with liquid skim milk protein concentrate (MPC) and micellar casein concentrate (MCC). Milk protein concentrate was produced using a spiral wound polymeric membrane, and MCC was produced using a 0.1-µm ceramic membrane by filtration at 50°C. Two DKP concentrations were used (0% and 0.15% wt/wt) within each of the 3 heat treatments. All beverages had no other additives and ran through heat treatment without coagulation. Ultracentrifugation (2-h run at 4°C) supernatants of the beverages were collected at 1, 5, 8, 12, and 15-d storage at 4°C. Phosphorus, Ca, and K concentrations in the beverages and supernatants were measured using inductively coupled plasma spectrometry. Protein composition of supernatants was measured using Kjeldahl and sodium dodecyl sulfate-PAGE. Micellar casein concentrate and MPC beverages with 0.15% DKP had higher concentrations of supernatant protein, Ca, and P than beverages without DKP. Protein, Ca, and P concentrations were higher in MCC supernatant than in MPC supernatant when DKP was added, and these concentrations increased over storage time, especially when lower heat treatments (HTST or no heat treatment) had been applied. Dipotassium phosphate addition caused the dissociation of α_S-, β-, and κ-casein, and casein proteolysis products out of the casein micelles, and DKP addition explained over 70% of the increase in supernatant protein, P, and Ca concentrations. Dipotassium phosphate could be removed from 7.5% of protein beverages made with fresh liquid MCC and MPC (containing a residual lactose concentration of 0.6% to 0.7% and the proportional amount of soluble milk minerals), as these beverages maintain heat-processing stability without DKP addition.

30 Sep 2023·Materials (Basel, Switzerland)

Luminescent Hybrid BPA.DA-NVP@Eu₂L₃ Materials: In Situ Synthesis, Spectroscopic, Thermal, and Mechanical Characterization.

Article

Author: Głuchowska, Halina ; Vlasyuk, Dmytro ; Puszka, Andrzej ; Stankevič, Marek ; Hnatejko, Zbigniew ; Łyszczek, Renata ; Podkościelna, Beata

A series of homogeneous hybrid BPA.DA-NVP@Eu₂L₃ materials were obtained through an in situ approach where the luminescent dopant was formed at the molecular level with different contents (0.1; 0.2; 0.5; 1; and 2% by weight). A Europium(III) complex (Eu₂L₃) with quinoline-2,4-dicarboxylic acid was applied as a luminescence additive while a polymer matrix consisted of a combination of bisphenol A diacrylate (BPA.DA) and N-vinylpyrrolidone (NVP) monomers. Synthesis steps and the final materials were monitored by NMR and Fourier transform infrared spectroscopy (FTIR). The emission, excitation spectra, lifetime, and quantum yield measurements were applied for the determination of the photophysical characteristics. The thermal and mechanical properties of the obtained materials were tested via thermal analysis methods (TG/DTG/DSC and TG-FTIR) in air and nitrogen atmospheres, dynamic mechanical analysis (DMA), and hardness and bending measurements. Generally, even a small addition of the metal complex component causes changes in the thermal, mechanical, and luminescent properties. Hybrid materials with a greater europium complex content are characterized by a lower stiffness and hardness while the heterogeneity and the flexibility of the samples increase. A very small amount of an Eu₂L₃ admixture (0.1% wt.) in a hybrid material causes an emission in the red spectral range and the luminescence intensity was reached for the BPA-DA-NVP@1%Eu₂L₃ material. These materials may be potentially used in chemical sensing, security systems, and protective coatings against UV.

15 Jun 2023·Toxicology and applied pharmacology

In silico and in vitro screening for carcinogenic potential of angiotensin-converting enzyme inhibitors and their degradation impurities.

Article

Author: Regulska, Katarzyna ; Mikolajczyk, Aleksandra ; Stanisz, Beata J. ; Matera-Witkiewicz, Agnieszka

According to some clinical observations, the use of angiotensin-converting enzyme inhibitors (ACEI) may be associated with an increased risk of cancer. The aim of the present study was to screen for the potential carcinogenicity, mutagenicity and genotoxicity of these drugs using in silico methodology. Delapril, enalapril, imidapril, lisinopril, moexipril, perindopril, ramipril, trandolapril, spirapril were thereby analyzed. In parallel, the corresponding degradation impurities, the diketopiperazine (DKP) derivatives, were also investigated. (Q)SAR computer software (VEGA-GUI and Lazar), available in the public domain, was employed. The obtained predictions suggested that none of the compounds tested (from the group of ACE-Is and DKPs) was mutagenic. Moreover, none of the ACE-Is was carcinogenic. The reliability of these predictions was high to moderate. In contrast, in the DKP group, ramipril-DKP and trandolapril-DKP were found to be potentially carcinogenic, but the reliability of this prediction was low. As for the genotoxicity screening, all compounds tested (ACE-I and DKP) were predicted to be active and genotoxic, with moexipril, ramipril, spirapril, and all DKP derivatives within the highest risk group. They were prioritized for experimental verification studies to confirm or exclude their toxic activity. On the other hand, the lowest risk of carcinogenicity was assigned to imidapril and its DKP. Then, a follow-up in vitro micronucleus assay for ramipril was performed. It showed that this drug was genotoxic via aneugenic activity, but only at concentrations exceeding real-life levels. At concentrations found in human blood after standard dose, ramipril was not genotoxic in vitro. Therefore, ramipril was considered safe for human use with a standard dosing regimen. The other compounds of concern (spirapril, moexipril and all DKP derivatives) should be subjected to analogous in vitro studies. We also concluded that the adopted in silico software was applicable for ACE-I toxicity prediction.

News (Medical) associated with Aspartyl-alanyl-diketopiperazine

28 Oct 2021

·www.biospace.com

Ampio Pharmaceuticals, Inc. to Report Fiscal 2021 Third Quarter Financial Results and Provide Corporate Business Update

ENGLEWOOD, Colo., Oct. 28, 2021 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, today announced it will host a conference call to discuss financial results for the quarter ended September 30, 2021 and provide a corporate business update on Wednesday, November 10, 2021, at 4:30 pm EDT/ 2:30 pm MT. Conference Call & Webcast: Wednesday, November 10, 2021, 4:30 pm EDT / 2:30 pm MT Webcast Link: Conference Call (listen only): Canada dial-in number (Toll Free): 1 833 950 0062 Canada dial-in number (Local): 1 226 828 7575 United States: 1 844 200 6205 United States (Local): 1 646 904 5544 All other locations: +1 929 526 1599 Access code: 385971 In order to submit questions, participants must have internet connectivity, as questions will only be addressed via the webcast. The conference call line will be in listen only mode. The conference call and webcast can also be accessed from the Investor Relations section of the Company's website at and will be archived there shortly after the live event. About Ampio Pharmaceuticals Ampio Pharmaceuticals, Inc. is a biopharmaceutical company primarily focused on the advancement of immunology-based therapies to treat prevalent inflammatory conditions for which there are limited treatment options. Ampio's lead drug, Ampion™, is backed by an extensive patent portfolio with intellectual property protection extending through 2037 and may be eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the Biologics Price Competition and Innovation Act (BPCIA). Forward Looking Statements Ampio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "believe," "expect," "plan," "anticipate," and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to Ampion and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biological License Application (BLA), the ability of Ampio to enter into partnering arrangements, clinical trials and decisions and changes in business conditions and similar events, the ability to receive regulatory approval to conduct clinical trials, that Ampion may be used to treat ARDS induced by COVID-19, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, under Ampio's Annual Report on Form 10-K and other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise. Company Codes: AMEX:AMPE

Financial StatementLicense out/in

21 Sep 2021

·www.biospace.com

Ampio Pharmaceuticals Receives Approval from the Drugs Controller General of India (DCGI) to Commence AP-019 Phase II Study in India

ENGLEWOOD, Colo., Sept. 21, 2021 /PRNewswire/ -- Ampio Pharmaceuticals (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, today announced regulatory approval from the Drugs Controller General of India (DCGI) of the Central Drugs Standard Control Organization (CDSCO) in the Phase II AP-019 clinical trial in India. The study will utilize inhaled Ampion™ to treat those suffering from respiratory distress due to COVID-19. Following presentation of Ampion to a Subject Expert Committee (SEC) established by the DCGI, the AP-019 treatment protocol was approved with no recommended changes. "More than a year and a half into the pandemic, healthcare practitioners still lack effective and easy-to-use therapies to treat the severe and often fatal respiratory distress experienced by many COVID-19 patients," said Mike Macaluso, President & CEO of Ampio. "We are grateful for the DCGI's swift attention and believe their decision underscores the critical medical need for Ampion as a potential treatment option." India has experienced over 33 million infections and over 440 thousand reported coronavirus-related deaths since the pandemic began, making it the country with the largest number of COVID-19 infections and deaths in the Middle East and Asia. While new infections are at 10% of their peak in early May, COVID-19 remains a continuing health threat in India. As an immunomodulatory agent with anti-inflammatory effects, Ampion interrupts the hyperactive immune response associated with COVID-19 and, as such, may improve the clinical outcome for patients suffering from its complications. Directly administering Ampion to patients by inhalation allows the drug to directly target and attenuate inflammation in the lungs. 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. On April 27, 2021, the company reported the earlier Phase I study not only met its primary endpoint of safety and tolerability, but top-line results also showed that Ampion reduced all-cause mortality in COVID-19 respiratory distress by 78% over the Standard of Care (SOC) for patients suffering from respiratory distress due to COVID-19. Specifically, mortality in the SOC group was 24%, while in the group treated with SOC and Ampion, mortality was only 5%. About Ampio Pharmaceuticals Ampio Pharmaceuticals, Inc. is a biopharmaceutical company primarily focused on the advancement of immunology-based therapies to treat prevalent inflammatory conditions for which there are limited treatment options. Ampio's lead drug, Ampion™, is backed by an extensive patent portfolio with intellectual property protection extending through 2037 and will be eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the Biologics Price Competition and Innovation Act (BPCIA). Forward Looking Statements Ampio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "believe," "expect," "plan," "anticipate," and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to Ampion and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biological License Application (BLA), the ability of Ampio to enter into partnering arrangements, clinical trials and decisions and changes in business conditions and similar events, the ability to receive regulatory approval to conduct clinical trials, that Ampion may be used to treat ARDS induced by COVID-19, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, under Ampio's Annual Report on Form 10-K and other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise. Media Contact Katie Kennedy katiek@gregoryfca.com 610-731-1045 Company Codes: AMEX:AMPE

License out/in

14 Jul 2021

·www.biospace.com

Ampio Pharmaceuticals, Inc. to Report Fiscal 2021 Second Quarter Financial Results and Provide Corporate Business Update

ENGLEWOOD, Colo., July 14, 2021 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, today announced it will host a conference call to discuss financial results for the quarter ended June 30, 2021, and provide a corporate business update on Wednesday, August 4, 2021, at 4:30 pm EDT/ 2:30 pm MT. The conference call will also be available from the Investor Relations section of the Company's website at and will be archived there shortly after the live event. About Ampio Pharmaceuticals Ampio Pharmaceuticals, Inc. is a biopharmaceutical company primarily focused on the advancement of immunology-based therapies to treat prevalent inflammatory conditions for which there are limited treatment options. Ampio's lead drug, Ampion™, is backed by an extensive patent portfolio with intellectual property protection extending through 2037 and will be eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the biologics price competition and innovation act (BPCIA). Forward Looking Statements Ampio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "believe," "expect," "plan," "anticipate," and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to Ampion and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biological License Application (BLA), the ability of Ampio to enter into partnering arrangements, clinical trials and decisions and changes in business conditions and similar events, the ability to receive regulatory approval to conduct clinical trials, that Ampion may be used to treat ARDS induced by COVID-19, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, under Ampio's Annual Report on Form 10-K and other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise. Company Codes: AMEX:AMPE

Financial StatementLicense out/in

100 Deals associated with Aspartyl-alanyl-diketopiperazine

External Link

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R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Chronic Pain	Phase 3	US	Ampio Pharmaceuticals, Inc.	19 Jun 2017
Osteoarthritis, Knee	Phase 3	US	Ampio Pharmaceuticals, Inc.	01 Sep 2014
COVID-19	Phase 2	US	Ampio Pharmaceuticals, Inc.	22 Jun 2021
Respiratory Distress Syndrome	Phase 2	US	Ampio Pharmaceuticals, Inc.	22 Jun 2021
Post Acute COVID 19 Syndrome	Phase 1	US	Ampio Pharmaceuticals, Inc.	26 Jul 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04880161 (CTgov)	Phase 1	Post Acute COVID 19 Syndrome	32	Ampion (Active)	qealcdzchn(uuhesmzhht) = dljxjplana clvfnouxyy (bmjdhlrrxd, rjapwvaarv - vtserzextx) View more	-	21 Sep 2023
				Placebo (Control)	qealcdzchn(uuhesmzhht) = oouxbqbwtg clvfnouxyy (bmjdhlrrxd, alfobotwxt - lselzeygzp) View more
NCT04868890 (CTgov)	Phase 2	COVID-19 \| Respiratory Distress Syndrome	200	Ampion (Active)	pjsxonnvqd(qytccnvcxb) = cksoitfjqd phclrgzlpm (cloawlgbep, wtlkzmneqc - grgsrxamhx) View more	-	07 Dec 2022
				Placebo (Control)	pjsxonnvqd(qytccnvcxb) = hnucgeizos phclrgzlpm (cloawlgbep, qufqfjqinj - pqoyjifojj) View more
NCT04839965 (CTgov)	Phase 2	COVID-19	36	Ampion (IV Ampion)	bdnqkktmmk(mnjariiphg) = fvvbbxzvlu qiiwdkvcxd (zthmmyughn, ngvidfiiep - sjnevscplq) View more	-	30 Nov 2022
				Saline (IV Placebo)	bdnqkktmmk(mnjariiphg) = nukiuyqyhu qiiwdkvcxd (zthmmyughn, kilwcrjsql - lsvbnqsejv) View more
NCT03988023 (AP-013, PRNewswire) Manual	Phase 3	Osteoarthritis, Knee	725	Ampion	wqhfdsqdfp(mkpzusboyn) = In addition, a separate statistical analysis of data from the 725 patients that the Company believed not to have been impacted by the pandemic demonstrated a statistically significant reduction in pain (p=0.0260) and improvement in function (p=0.0073) afrdkdpsmz (hwqvukrjas )	Positive	15 Sep 2021
NCT04606784 (PRNewswire) Manual	Phase 1	COVID-19 respiratory infection	-	Standard of Care+Ampion	sxmyxtbtcr(zzuglbsrfh) = no remarkable adverse events with Ampion treatment, and no drug-related serious adverse events were reported lladvawfjx (kiafklyxbu )	Positive	27 Apr 2021
				Standard of Care
NCT03182686 (AP-003-C, Pubmed) Manual	Phase 3	Osteoarthritis, Knee	168	Aspartyl-alanyl-diketopiperazine	hspgeqzdeg(vieueaboin) = slwvncvyvx noujflrmwp (olggwsplxk, 63.4 ~ 78.3) View more	Positive	18 Jun 2018
				Placebo	uzmkclwynl(xxmeyjszpk) = dhapcdpeix ninvueythu (fsncvlxmnj )
NCT02556710 \| NCT02024529 (Pubmed \| Orthopedics)	Phase 3	Osteoarthritis, Knee	417	LMWF-5A	cihupebyiv(lyuwiyhylg) = jpljejndqr vwbekrusiv (xrhfiqxxru )	Positive	01 Jan 2018
				Saline	cihupebyiv(lyuwiyhylg) = goqqkojxem vwbekrusiv (xrhfiqxxru )

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