Lowell Therapeutics, Inc. · Lowell, Massachusetts

Developing products for critically ill patients.

We developed Niyad, an investigational regional anticoagulant for the dialysis circuit in hospital patients with acute kidney injury.

Founded2018
HeadquartersLowell, MA
Lead productNiyad
FDA statusBreakthrough Device
About us

One problem in the ICU, done properly.

Patients in the intensive care unit with sudden kidney failure often need continuous renal replacement therapy (CRRT): dialysis on an artificial kidney machine, around the clock. Blood in that circuit has to be kept from clotting.

Lowell Therapeutics was founded in 2018 to develop a regional anticoagulant for this use. Our lead product, Niyad, is a lyophilized (freeze-dried) formulation of nafamostat, a synthetic serine protease inhibitor with anticoagulant activity.

The active drug in Niyad, nafamostat, is approved in Japan and South Korea as a regional anticoagulant for the dialysis circuit, for disseminated intravascular coagulation and for acute pancreatitis.

Lowell was acquired by AcelRx Pharmaceuticals (now Talphera, Inc.) in January 2022, in a $32.5 million transaction.

Pipeline

Two programs built on nafamostat.

ProgramDescriptionStatus
NiyadDevice, lyophilized nafamostat
Regional anticoagulant for the dialysis circuit during CRRT in hospitalized acute kidney injury patients. A second intended indication is intermittent hemodialysis for chronic kidney disease patients in dialysis centers.Investigational · IDE · Breakthrough Device
LTX-608Drug, nafamostat for IV infusion
Proprietary nafamostat formulation for direct IV infusion, being developed for acute respiratory distress syndrome (ARDS) and disseminated intravascular coagulation (DIC).In development

Niyad is being studied under an investigational device exemption (IDE) and has received Breakthrough Device Designation from the U.S. FDA. It is not approved for commercial use in the United States.

Leadership

Built by a life-sciences operator.

JW
James Wilkie
Co-founder · President & CEO

James has 38 years of experience developing both drugs and devices. He spun Lowell Therapeutics out of La Jolla Pharmaceutical Company, where he was VP of New Enterprise Development. Earlier he was COO of Pluromed until its sale to Sanofi in 2012, and co-founded Surgical Sealants. He holds 4 issued patents and a B.S. in Engineering from the University of Massachusetts.

Milestones

Four years, one product.

2018

Lowell Therapeutics is founded in Lowell, Massachusetts.

Oct 2021

Closes a $4.0M seed financing.

Nov 2021

AcelRx announces it will acquire Lowell.

Jan 2022

Acquisition closes: $32.5M, bringing Niyad and LTX-608 into AcelRx, now Talphera.

Contactjames@ltx.life

Lowell Therapeutics, Inc. · 110 Canal Street, Lowell, MA 01852, United States