alunacedase alfa (APN01) / Apeiron Biologics 
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  • ||||||||||  alunacedase alfa (APN01) / Apeiron Biologics
    Journal:  Clinical grade ACE2 as a universal agent to block SARS-CoV-2 variants. (Pubmed Central) -  Aug 11, 2022   
    Here, we report that all SARS-CoV-2 variants analyzed, including variants of concern (VOC) Alpha, Beta, Gamma, Delta, and Omicron, exhibit enhanced binding affinity to clinical grade and phase 2 tested recombinant human soluble ACE2 (APN01)...Effective inhibition of infections with SARS-CoV-2 variants was validated and confirmed in two independent laboratories. These data show that SARS-CoV-2 variants that have emerged around the world, including current VOC and several variants of interest, can be inhibited by soluble ACE2, providing proof of principle of a pan-SARS-CoV-2 therapeutic.
  • ||||||||||  alunacedase alfa (APN01) / Apeiron Biologics
    Journal:  Peptides-based therapeutics: Emerging potential therapeutic agents for COVID-19. (Pubmed Central) -  Jun 15, 2022   
    A candidate drug, RhACE2-APN01 based on recombinant hACE2 peptide has already entered phase II clinical trials. This review sheds light on different aspects of the feasibility of using peptide-based therapeutics as the promising therapeutic route for COVID-19.
  • ||||||||||  alunacedase alfa (APN01) / Apeiron Biologics
    Enrollment open, Trial completion date, Trial primary completion date:  Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Inhaled APN01 Developed as Treatment for COVID-19 (clinicaltrials.gov) -  Apr 12, 2022   
    P1,  N=40, Recruiting, 
    While there does not appear to be a consistent acute vasodilatory response to single doses of GSK2586881 in participants with PAH, the potential benefits in terms of chronic vascular remodeling remain to be determined. Trial completion date: Jan 2022 --> Jun 2022 | Trial primary completion date: Jan 2022 --> Jun 2022 | Not yet recruiting --> Recruiting
  • ||||||||||  Trial completion, Trial completion date, Trial primary completion date:  A Dose-escalation Study in Subjects With Pulmonary Arterial Hypertension (PAH) (clinicaltrials.gov) -  Jun 17, 2019   
    P2,  N=23, Completed, 
    Not yet recruiting --> Recruiting Recruiting --> Completed | Trial completion date: Oct 2019 --> May 2019 | Trial primary completion date: Oct 2019 --> May 2019
  • ||||||||||  Journal:  A potential therapeutic role for Angiotensin Converting Enzyme 2 in human pulmonary arterial hypertension. (Pubmed Central) -  Jun 7, 2019   
    P=N/A
    Our objective was to determine the effects of rhACE2 in PAH.We defined the molecular effects of Mas1 activation using porcine pulmonary arteries, measured AngII/Ang-(1-7) levels in human PAH and conducted a phase IIa, open-label pilot study of a single infusion of rhACE2 (GSK2586881, 0.2 or 0.4 mg·kg intravenously).Superoxide dismutase 2 (SOD2) and inflammatory gene expression were identified as markers of Mas1 activation...Augmentation of ACE2 in a pilot study was well-tolerated, associated with improved pulmonary hemodynamics and reduced markers of oxidant and inflammatory mediators. Targeting this pathway may be beneficial in human PAH.
  • ||||||||||  Review, Journal:  Targeting the renin-angiotensin system as novel therapeutic strategy for pulmonary diseases. (Pubmed Central) -  Apr 11, 2019   
    Personalized medicine through genetic screening and phenotyping for angiotensinogen or ACE would aid treatment especially for non-responsive patients. This review serves to provide an update on the latest development in the field of RAS targeting for pulmonary diseases, and offer some insights into future direction.
  • ||||||||||  Enrollment change, Trial completion date, Trial termination, Trial primary completion date:  Study of GSK2586881 on Acute Hypoxia and Exercise (clinicaltrials.gov) -  Jan 28, 2019   
    P1,  N=17, Terminated, 
    This review serves to provide an update on the latest development in the field of RAS targeting for pulmonary diseases, and offer some insights into future direction. N=25 --> 17 | Trial completion date: Jun 2019 --> Jan 2019 | Recruiting --> Terminated | Trial primary completion date: Jun 2019 --> Jan 2019; Study terminated for technical feasibility, operational considerations and futility in line with pre-specified criteria.
  • ||||||||||  Trial completion date, Trial primary completion date:  Study of GSK2586881 on Acute Hypoxia and Exercise (clinicaltrials.gov) -  Sep 25, 2018   
    P1,  N=25, Recruiting, 
    N=25 --> 17 | Trial completion date: Jun 2019 --> Jan 2019 | Recruiting --> Terminated | Trial primary completion date: Jun 2019 --> Jan 2019; Study terminated for technical feasibility, operational considerations and futility in line with pre-specified criteria. Trial completion date: Dec 2018 --> May 2019 | Trial primary completion date: Dec 2018 --> May 2019
  • ||||||||||  Enrollment open:  Study of GSK2586881 on Acute Hypoxia and Exercise (clinicaltrials.gov) -  May 4, 2018   
    P1,  N=25, Recruiting, 
    Trial completion date: Dec 2018 --> May 2019 | Trial primary completion date: Dec 2018 --> May 2019 Suspended --> Recruiting
  • ||||||||||  Trial completion date, Trial primary completion date:  Study of GSK2586881 on Acute Hypoxia and Exercise (clinicaltrials.gov) -  Feb 13, 2018   
    P1,  N=25, Suspended, 
    Not yet recruiting --> Recruiting Trial primary completion date: Feb 2018 --> Sep 2018 | Trial completion date: Aug 2018 --> Sep 2018
  • ||||||||||  Trial suspension:  Study of GSK2586881 on Acute Hypoxia and Exercise (clinicaltrials.gov) -  Dec 4, 2017   
    P1,  N=25, Suspended, 
    Trial primary completion date: Feb 2018 --> Sep 2018 | Trial completion date: Aug 2018 --> Sep 2018 Recruiting --> Suspended
  • ||||||||||  Enrollment open:  Study of GSK2586881 on Acute Hypoxia and Exercise (clinicaltrials.gov) -  Jun 20, 2017   
    P1,  N=25, Recruiting, 
    Initiation date: Sep 2017 --> Jan 2018 | Trial primary completion date: May 2019 --> Sep 2019 Not yet recruiting --> Recruiting