Day: January 8, 2018

Trial Results

Momenta Reports Positive Top-Line Phase I Data for M281 in Healthy Volunteers

January 8, 2018

Momenta Pharmaceuticals reported positive top-line data showing safety, tolerability and proof of mechanism for M281 in a Phase I single ascending dose (SAD) and multiple ascending dose (MAD) study of normal human volunteers. Over the 98-day MAD study, M281 exhibited no serious adverse events, was well-tolerated and decreased circulating IgG levels up to 89% with a mean reduction of 84%. M281 is a fully human anti-neonatal Fc receptor (FcRn) aglycosyl­ated immunoglobulin G (IgG1) monoclonal antibody, engineered to reduce circulating pathogenic IgG antibodies, in excess of that achieved by any current treatments, by com­pletely blocking endogenous IgG recycling via FcRn. Momenta Pharmaceuticals will finalize development strategy and initiate a proof of concept clinical trial in the second half of 2018, pending regulatory feedback. The Phase 1 randomized, double-blind, placebo-controlled study evaluated the safety, tolerability, pharmacokinetics and pharmacodynamics of M281.

The Pulse on Study Conduct

Educate yourself on new therapeutic areas

January 8, 2018

Medical knowledge for the vast assimi­lation of clinical research guidelines is necessary for anyone entering the field. The diverse regulatory landscape requires us to stay abreast of changes that impact patient safety data. It is a multifaceted learning process with educational requirements that vary by role. We should never expect anyone to have every answer, or to know everything about a protocol/therapeutic area. That sets an unreal­istic standard that undermines performance.


OMB Issues New Notice on Common Rule Delay

January 8, 2018

The OMB Office of Information and Regulatory Affairs (OIRA) posted a notice on its website Jan. 5  noting that OIRA is reviewing a final rule titled “Federal Policy for the Protection of Human Subjects: Delay of the Revisions to the Federal Policy for the Protection of Human Subjects.” This notice follows but does not replace an October posting noting the review of a proposed final rule titled “Federal Policy for the Protection of Human Subjects: Proposed 1-Year Delay of the General Implementation Date While Allowing the Use of Three Burden-Reducing Provisions During the Delay Year” suggesting a more general delay of unknown length.  The three provisions were not specified in the listing. It’s currently unclear whether either rule will be published as a final rule before the Jan. 19, 2018, implementation date. Read the posting here:


FDA & CTTI Launch Patient Forum to Boost Engagement in Drug Development

January 8, 2018

The Patient Engagement Collabora­tive is gearing up for a launch in early 2018. The new, external panel is being built by the FDA and the Clinical Trials Trans­formation Initiative (CTTI), a public-private partnership between the FDA and Duke University. The panel will act as a forum for discussing new methods to increase patient participation in the agency’s decisionmak­ing process. It will provide input on incor­porating patient-preferences into reviews of medical products and trial protocols to make patient engagement an integral part of drug development.