View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. Comment
September 4, 2018updated 11 Jul 2022 9:55am

Promising DMT candidate for Alzheimer’s disease could reach trials in 2019

A new therapeutic antibody candidate for the treatment of Alzheimer's disease (AD), PMN310, showed promising results according to its developer, ProMIS Neurosciences, a biotechnology company focused on discovering and developing antibody therapeutics targeting toxic oligomers implicated in the development and progression of neurodegenerative diseases, in particular for AD, Parkinson’s disease (PD), and amyotrophic lateral sclerosis (ALS).

By GlobalData Healthcare

A new therapeutic antibody candidate for the treatment of Alzheimer’s disease (AD), PMN310, showed promising results according to its developer, ProMIS Neurosciences, a biotechnology company focused on discovering and developing antibody therapeutics targeting toxic oligomers implicated in the development and progression of neurodegenerative diseases, in particular for AD, Parkinson’s disease (PD), and amyotrophic lateral sclerosis (ALS).

Free Case Study
img

Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
Enter your details here to receive your free Case Study.

PMN310, in late preclinical development, is a humanised antibody that has the ability to selectively target and neutralise toxic amyloid beta oligomers (AβO), a known cause of AD, with no significant cross-reactivity to monomers or fibrils, potentially preventing neurodegeneration. ProMIS plans to submit an investigational new drug (IND) application to the FDA in late 2018 and PMN310 is anticipated to enter Phase I clinical trials in the second half of 2019.

Preclinical studies showed that PMN310 has no binding to Aβ plaque in the AD brain, which is believed to be the main cause of the development of amyloid-related imaging abnormalities (ARIA). These results showed better outcomes compared to Biogen’s and Eisai’s promising disease-modifying therapies (DMTs) in development for AD, BAN2401 and aducanumab, which both showed significant Aβ plaque reactivity and development of ARIA, in comparison, ProMIS’ candidate can address observed issues of efficacy and safety in treated AD patients.

Share price decline and safety doubts

Last month, at the 2018 Alzheimer’s Association International Conference, Biogen and Eisai presented the detailed results from the Phase II study (Study 201) of BAN2401, showing its potential to be the first DMT drug for AD on the market.

However, despite the positive results, share prices of both companies still declined due to concern expressed by researchers about the study design and previous results, as initial data from the study, published in December 2017, showed that BAN2401 did not meet the primary endpoint. The only other trials that have shown a similar level of promise are EMERGE and ENGAGE trials, studying aducanumab, which targets AβO. The results of both trials are expected in 2019 or early 2020.

Despite the positive results from Phase II clinical trials and the potential to be the first DMT drugs to enter the AD market, both BAN2401 and aducanumab suffer from doubts about safety, namely the potential for developing ARIA. This gives PMN310 an opportunity to address these issues, becoming the first-in-class therapy by offering better safety and efficacy profiles; however, this will not be known until further studies are performed.

Related Companies

Free Case Study
img

Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
Enter your details here to receive your free Case Study.

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. A weekly roundup of the latest news and analysis, sent every Friday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU

Thank you for subscribing to Pharmaceutical Technology