Imara Announces FDA Fast Track Designation for IMR-687 for the Treatment of Sickle Cell Disease

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Imara,
Inc., a clinical-stage biopharmaceutical company focused on sickle
cell disease and other hemoglobinopathies, today announced that the U.S.
Food and Drug Administration (FDA) has granted Fast Track designation to
IMR-687, the company’s lead product candidate for the treatment of
sickle cell disease. IMR-687 is currently being evaluated in a
multi-national Phase 2a clinical trial in adult patients.

“We believe that IMR-687 has the potential to transform outcomes for
people living with sickle cell disease. It has been designed as an oral,
once-daily therapy with a dual mechanism of action to address both red
blood cell and white blood cell pathologies associated with the
disease,” said Rahul D. Ballal, Chief Executive Officer of Imara. “The
Fast Track designation granted by the FDA for IMR-687 is designed to
allow us to advance this novel, investigative therapy more rapidly
through increased opportunities for dialogue and collaboration with the
Agency.”

Fast Track designation aims to facilitate the development and expedite
the review of drugs to treat serious conditions where an unmet medical
need exists, with the goal of getting important new therapeutics to
patients earlier.

About Sickle Cell Disease

Sickle cell disease is a rare, genetically inherited condition that
alters hemoglobin, the protein in red blood cells that transports oxygen
throughout the body. The altered hemoglobin distorts red blood cells
into a sickle, or crescent, shape. Painful episodes can occur when
sickled red blood cells, which are stiff and inflexible, get stuck in
small blood vessels. These episodes deprive tissues and organs of
oxygen-rich blood and can lead to vaso-occlusive crisis (VOC), acute
chest syndrome (ACS), and permanent damage to organs including the
liver, spleen, kidney and brain.

Sickle cell disease represents a critical unmet medical need globally,
as a rare disease in many parts of the world including in the United
States and as an endemic condition in certain African countries.

About IMR-687

IMR-687 has been designed to address the underlying pathology of sickle
cell disease. An orally-administered, highly potent and selective
phosphodiesterase 9 (PDE9) inhibitor, IMR-687 has the potential to be a
disease-modifying therapeutic for sickle cell disease as well as other
hemoglobinopathies. Pre-clinical data demonstrate IMR-687 reduces both
the sickling of red blood cells and blood vessel occlusion that cause
debilitating pain, organ damage, and early mortality in affected
patients. In a Phase 1 clinical trial in healthy volunteers, IMR-687 was
demonstrated to be well-tolerated. IMR-687 has been granted U.S. Orphan
Drug Designation, U.S. Rare Pediatric Designation and Fast Track
Designation by the Food and Drug Administration (FDA).

About Imara

Imara, Inc. is dedicated to developing novel therapeutics for patients
with sickle cell disease and other hemoglobinopathies. Imara is
currently developing IMR-687, a highly selective, potent small molecule
inhibitor of PDE9, to treat patients with sickle cell disease. IMR-687
has been specifically designed to treat patients with sickle cell
disease by both reducing red blood cell sickling and adherence of white
blood cells to the blood vessel wall. These combined effects may lead to
a lower occurrence of blockage of blood vessels that are underlying
causes of the pathology of sickle cell disease. IMR-687 successfully
completed a Phase 1 study in healthy volunteers and is currently being
evaluated in a multi-national Phase 2a study in adult patients with
sickle cell disease. Imara expects to broaden its development of
IMR-687, with clinical trials of IMR-687 planned in pediatric patients
with sickle cell disease as well as in patients with beta thalassemia,
which is a group of genetic blood disorders that often leads to chronic
anemia and other serious complications. For more information about
Imara, visit www.imaratx.com.

Contacts

Imara Media Contact:
Krystle Gibbs
Ten Bridge
Communications
508-479-6358
[email protected]

Imara Company / Investor Contact:
Michael Gray
857-320-4636
[email protected]