About us | Advertise with us | Contact us
Posted: 15 March 2022 | European Pharmaceutical Review | No comments yet
Pipe-307 demonstrated linear pharmacokinetic (PK) data consistent with pre-clinical modelling and was generally well tolerated at all doses in 70 healthy adult volunteers.
Pipeline Therapeutics has reported positive clinical data from its recently completed Phase I clinical trial evaluating the safety and tolerability of Pipe-307 in healthy volunteers.
Pipe-307, the company’s lead programme for myelin restoration, is an oral, highly selective antagonist of the muscarinic M1 receptor that is being developed for the treatment of multiple sclerosis (MS). Currently, there are no approved medicines that support myelin restoration, which represents a significant unmet medical need in the treatment of MS.
The Phase I clinical results reported comprised multiple dose cohorts of Pipe-307 in a total of 70 healthy volunteer subjects. Pipe-307 demonstrated linear pharmacokinetic (PK) data consistent with pre-clinical modelling and was generally well tolerated across all dose cohorts. Importantly, analysis of a battery of neuropsychological measures, including tests involving psychomotor, attention, learning, and executive function, were administered in the Phase I study and showed no significant PK or dose related effects on cognitive function.
“We believe that Pipe-307, as a first-in-class myelin restoration therapeutic, represents a differentiated and clinically-validated approach for the treatment of MS,” commented Dr Stephen Huhn, Chief Medical Officer and Senior Vice President of Clinical Development of Pipeline. “The results of the single- and multiple-ascending dose cohorts from the completed study demonstrate a favourable safety and PK profile, and we are pleased to have met our primary and secondary endpoints in this study. These encouraging Phase I results give us great confidence to advance Pipe-307 into clinical studies with MS patients as soon as possible.”
Carmine Stengone, President and CEO of Pipeline, added, “Multiple sclerosis is a devastating neurodegenerative disease that impacts almost three million people worldwide, and therapies that are designed to restore neuronal damage, like Pipe-307, are desperately needed. Our clinical plans remain on track and we look forward to evaluating Pipe-307 in MS patients.”
The completed Phase I clinical trial of Pipe-307 was a randomised, double-blind, placebo-controlled trial in 70 healthy adult volunteers. The trial was conducted in three parts: (1) a Single Ascending Dose (SAD) study, (2) a Multiple Ascending Dose (MAD) study, and (3) a selected SAD cohort in a fed state to evaluate the effect of food on bioavailability of Pipe-307. The primary endpoint of the trial was to measure the safety and tolerability of Pipe-307, with a secondary endpoint measuring the effect of PIPE-307 on pharmacokinetics. This study was completed at a single centre in Australia.
Clinical Development, Clinical Trials, Drug Development, Pharmacokinetics, Research & Development (R&D), Therapeutics
Clinical Development, Clinical Trials, Drug Development, Pharmacokinetics, Research & Development (R&D), Therapeutics
All subscriptions include online membership, giving you access to the journal and exclusive content.
By Hannah Balfour (European Pharmaceutical Review)
By Anna Begley (European Pharmaceutical Review)
By Anna Begley (European Pharmaceutical Review)
Your email address will not be published. Required fields are marked *
This site uses Akismet to reduce spam. Learn how your comment data is processed.
Write for us | Advertise with us
European Pharmaceutical Review is published by: Russell Publishing Ltd. Court Lodge Hogtrough Hill Brasted, Kent, TN16 1NU United Kingdom
© Russell Publishing Limited, 2010-2022. All rights reserved.
Website development by e-Motive Media Limited.
This website uses cookies to improve your experience while you navigate through the website. Out of these cookies, the cookies that are categorised as ”Necessary” are stored on your browser as they are as essential for the working of basic functionalities of the website. For our other types of cookies “Advertising & Targeting”, “Analytics” and “Performance”, these help us analyse and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these different types of cookies. But opting out of some of these cookies may have an effect on your browsing experience. You can adjust the available sliders to ‘Enabled’ or ‘Disabled’, then click ‘Save and Accept’. View our Cookie Policy page.
Necessary cookies are absolutely essential for the website to function properly. This category only includes cookies that ensures basic functionalities and security features of the website. These cookies do not store any personal information.
CookieDescriptioncookielawinfo-checkbox-advertising-targetingThe cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Advertising & Targeting".cookielawinfo-checkbox-analyticsThis cookie is set by GDPR Cookie Consent WordPress Plugin. The cookie is used to remember the user consent for the cookies under the category "Analytics".cookielawinfo-checkbox-necessaryThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Necessary".cookielawinfo-checkbox-performanceThis cookie is set by GDPR Cookie Consent WordPress Plugin. The cookie is used to remember the user consent for the cookies under the category "Performance".PHPSESSIDThis cookie is native to PHP applications. The cookie is used to store and identify a users' unique session ID for the purpose of managing user session on the website. The cookie is a session cookies and is deleted when all the browser windows are closed.viewed_cookie_policyThe cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data.zmember_loggedThis session cookie is served by our membership/subscription system and controls whether you are able to see content which is only available to logged in users.