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Details:
Clinical Hold has placed on DM199, a recombinant form of human tissue KLK1, based on submission of three serious adverse event reports to the FDA related to clinically significant, transient hypotension (low blood pressure) occurring shortly after initiation of IV dose.
Lead Product(s): DM199
Therapeutic Area: Neurology Product Name: DM199
Highest Development Status: Phase II/ Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 06, 2022
Details:
In the study, 45 patients received placebo and 46 were treated with DM199. During the 90-day follow-up period, recurrent ischemic stroke occurred in 6 patients of the placebo arm versus none in the DM199 arm. Moreover, 4 of the recorded strokes in the placebo arm were fatal.
Lead Product(s): DM199
Therapeutic Area: Cardiology/Vascular Diseases Product Name: DM199
Highest Development Status: Phase II/ Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 08, 2021
Details:
DiaMedica's presentation include an abstract on REDUX Study: A Multicenter Study of DM199 in Chronic Kidney Disease Stage II or III” patients and an abstract on Kallikrein Protein (KLK1) Levels in Patients with Chronic Kidney Disease and Normal Kidney Function.
Lead Product(s): DM199
Therapeutic Area: Nephrology Product Name: DM199
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 05, 2021
Details:
DM199 is a recombinant (synthetic) form of the human tissue kallikrein-1 (KLK1). DiaMedica plans to submit an investigational new drug (IND) application to the FDA for the phase 2/3 study in the first quarter of 2021.
Lead Product(s): DM199
Therapeutic Area: Cardiology/Vascular Diseases Product Name: DM199
Highest Development Status: Phase II/ Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 09, 2021
Details:
Net proceeds to be used in continuing clinical and product development activities, including the addition of a new cohort III to its REDUX study to be comprised of Type II diabetes mellitus patients with CKD, hypertension and albuminuria, and general corporate purposes.
Lead Product(s): DM199
Therapeutic Area: Immunology Product Name: DM199
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Guggenheim Securities, LLC
Deal Size: $20.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering August 06, 2020
Details:
DM199 met primary safety and tolerability endpoints in ReMEDy study top-line data. There was also a demonstrated therapeutic effect in participants who received tissue plasminogen activator (tPA) prior to enrolment.
Lead Product(s): DM199
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 13, 2020
Details:
WI facility to support the trial using its GPEx cell line development technology. DiaMedica intends to initiate enrollment in the study in the next few weeks.
Lead Product(s): DM199
Therapeutic Area: Nephrology Product Name: DM199
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 23, 2020
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