News

Ascletis Gains Exclusive China Market Rights from Presidio to Clinical Stage
Hepatitis C Virus (HCV) NS5A Inhibitor PPI-668

Hangzhou, China, Research Triangle Park, NC and San Francisco, CA – November 10, 2014 – Ascletis and Presidio announced today that they have entered into an exclusive licensing agreement for Presidio’s clinical stage, HCV NS5A inhibitor PPI-668, also known as ASC16. The agreement provides Ascletis with exclusive rights to develop and commercialize PPI-668 in Greater China. Presidio will retain all rights in the rest of the world. (PDF)

Pharco Pharmaceuticals Licenses Clinical Stage Hepatitis C Virus (HCV)
NS5A Inhibitor PPI-668 from Presidio Pharmaceuticals

Alexandria, Egypt and San Francisco, CA – November 10, 2014 – Pharco and Presidio today announced that they have entered into an exclusive license agreement for Presidio’s HCV NS5A inhibitor PPI-668 for development and commercialization to treat HCV infection in Egypt. This exclusive license includes an opportunity for Pharco to expand its licensed territory to one or more additional countries in the MENA region. (PDF)

Presidio Pharmaceuticals Announces a High Rate of Virologic Response in an Ongoing Phase 2 Hepatitis C Trial of a New All-Oral Combination of Presidio’s PPI-668 with Boehringer Ingelheim’s Faldaprevir and Deleobuvir

San Francisco, CA – November 2, 2013 – Presidio Pharmaceuticals, Inc. announced today positive preliminary results from an ongoing Phase 2 clinical trial of an investigational, interferon-free, all-oral combination treatment for patients with chronic hepatitis C virus (HCV) infection. The collaborative trial is evaluating Presidio’s pan- genotypic HCV NS5A inhibitor (PPI-668) in combination with Boehringer Ingelheim’s HCV protease inhibitor faldaprevir (BI 201335) and non-nucleoside HCV polymerase inhibitor deleobuvir (BI 207127), with and without ribavirin (RBV). (PDF)

Investigational Interferon-free Regimen Demonstrates Undetectable Hepatitis C Virus in All Patients Reaching End of Treatment in Ongoing Phase 2 Trial

Ridgefield, CT – October 8, 2013 – Boehringer Ingelheim Pharmaceuticals, Inc. today announced that interim data from its Phase 2 hepatitis C (HCV) clinical collaboration (NCT01859962) with Presidio Pharmaceuticals have been accepted as a late breaker poster presentation at the 64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), also known as The Liver Meeting®, taking place November 1-5 in Washington, D.C. The poster presentation will be on Monday, November 4.

This ongoing study evaluates a 12-week, all-oral regimen of Boehringer Ingelheim’s investigational compounds, the protease inhibitor, faldaprevir (BI 201335), and non-nucleoside NS5B polymerase inhibitor, deleobuvir (BI 207127), in combination with Presidio’s investigational pan-genotypic NS5A inhibitor, PPI-668, with and without ribavirin. The study is fully enrolled (36 patients) and to date, 97 percent of patients (28/29) have achieved undetectable levels of virus by week 4 on treatment, also known as rapid virologic response (RVR). Additionally, 100 percent of patients who have completed treatment (13/13) achieved non-detectable levels of virus at the end of treatment. (link)

Boehringer Ingelheim Expands Investigation of Interferon-free Hepatitis C Treatment Regimens to Reach More Patient Types through Presidio Pharmaceuticals Clinical Collaboration

Ridgefield, CT – September 10, 2013 – Boehringer Ingelheim Pharmaceuticals, Inc. today announced the completion of patient enrollment for a Phase 2a clinical trial (NCT01859962) investigating a new interferon-free, all-oral, direct-acting antiviral (DAA) combination treatment for patients with genotype-1a chronic hepatitis C virus (HCV) infection. This trial is conducted in collaboration with Presidio Pharmaceuticals, Inc. and evaluates Boehringer Ingelheim’s investigational compounds, the protease inhibitor faldaprevir (BI 201335) and non-nucleoside NS5B polymerase inhibitor, deleobuvir (BI 207127), in combination with Presidio’s investigational pan-genotypic NS5A inhibitor, PPI-668, with and without ribavirin. (Link)

Presidio Pharmaceuticals Announces Collaboration with
Boehringer Ingelheim

San Francisco, CA – March 12, 2013 – Presidio Pharmaceuticals, Inc. announced today a non-exclusive collaboration with Boehringer Ingelheim for a Phase IIa clinical trial of an interferon-free, all-oral, direct-acting antiviral (DAA) combination treatment for patients with chronic hepatitis C virus (HCV) infection.The collaborative trial will evaluate Presidio’s pan-genotypic HCV NS5A inhibitor (PPI-668) in combination with Boehringer Ingelheim’s HCV protease inhibitor faldaprevir (BI201335) and its non-nucleoside HCV polymerase inhibitor (BI207127), with or without ribavirin. PDF

Presidio Pharmaceuticals Successfully Completes Phase 1 Proof-of Concept for PPI-668, its Potent HCV NS5A Inhibitor, in Hepatitis C Patients with Genotype-1 Infection

San Francisco, CA – June 26, 2012 – Presidio Pharmaceuticals, Inc. announced today successful completion of Phase 1b clinical testing of its lead HCV NS5A inhibitor in patients with HCV genotype-1 infection, with positive efficacy and safety observations supporting advancement of PPI-668 to Phase 2 combination studies.

The randomized, blinded Phase 1b trial of PPI-668 involved sequential cohorts of treatment-naïve HCV genotype-1 patients who received oral doses of PPI-668 of 40, 80, 160 or 240 mg, once daily for three consecutive days. Within each 10-patient cohort, patients were randomized 8:2 to PPI-668 or placebo.

In all of the Phase 1b dose cohorts, PPI-668 was well tolerated with no serious or severe adverse events, no premature treatment discontinuations and no apparent pattern of treatment-related clinical side effects or laboratory abnormalities PDF

Presidio Pharmaceuticals Announces a New Clinical Candidate, PPI-383, a Novel Pan-Genotypic Non-Nucleoside Polymerase Inhibitor for HCV

San Francisco, CA – April 21, 2012 – Presidio Pharmaceuticals, Inc. announced today that PPI-383, a novel non-nucleoside polymerase inhibitor to treat hepatitis C virus (HCV), has been nominated for clinical development and will be profiled by Richard Colonno, Ph.D., Chief Scientific Officer, in poster 1173 at the 47th Annual EASL meeting being held in Barcelona, Spain on April 21st, 2012.

PPI-383 is a potent, pan-genotypic inhibitor of HCV discovered at Presidio, which exhibits a favorable pharmacokinetic and safety profile in multiple animal species following oral dosing. PPI-383 binds to the Palm II pocket of the HCV polymerase (NS5B) and possesses biochemical and pharmaceutical properties critical to successful drug development, including a potential for once-daily oral dosing and minimal potential for drug-drug interactions. PPI-383 is currently undergoing further preclinical evaluation to support initiation of clinical studies alone and in combination with Presidio’s lead NS5A inhibitor, PPI-668, next year. PDF

Presidio Pharmaceuticals Announces Phase 1a-1b Clinical Results with PPI-668, a Potent Pan-genotypic HCV NS5A Inhibitor

San Francisco, CA – April 19, 2012 – Presidio Pharmaceuticals, Inc. announced results today from a Phase 1a-1b clinical trial of PPI-668, a potent, pan-genotypic HCV NS5A inhibitor being developed for the treatment of patients with chronic hepatitis C.

PPI-668 is Presidio’s second NS5A inhibitor to progress to clinical testing after Phase 1 clinical evaluation of PPI-461 (results previously reported at the annual meetings of the American Association for the Study of Liver Diseases (AASLD) in 2010 and 2011). Compared to PPI-461, PPI-668 exhibits more potent activity in vitro against HCV genotypes 3a and 6a and has a superior resistance profile. PDF

Presidio Pharmaceuticals Reports Progress with Hepatitis C Antiviral Programs

San Francisco, CA – January 09, 2012 – Presidio Pharmaceuticals, Inc. announced today the successful completion of a Phase 1a dose-ranging assessment of PPI-668, a potent, pan-genotypic second-generation hepatitis C virus (HCV) NS5A inhibitor, in healthy volunteers and subsequent advancement to a Phase 1b assessment of the dose-related efficacy in hepatitis C patients. PDF

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