Cadent Therapeutics Announces FDA Orphan Drug Designation for CAD-1883 for Spinocerebellar Ataxia

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Cadent
Therapeutics, a company focused on the development of therapies to
improve the lives of patients with movement and cognitive disorders,
today announced that the U.S. Food and Drug Administration (FDA) has
granted Orphan Drug Designation to CAD-1883, an investigational
treatment for spinocerebellar ataxia (SCA), a genetic disorder
characterized by progressive loss of coordination, slurred speech,
difficulty controlling eye movements and cognitive dysfunction. Designed
as a selective positive allosteric modulator of small-conductance,
calcium-activated potassium ion channels (SK PAM), CAD-1883 has the
potential to regulate neuronal firing and reduce disabilities in
patients with SCA.

“We are pleased to obtain Orphan Drug Designation for CAD-1883 in SCA, a
progressively debilitating disease for which there are currently no
approved treatments,” said Jodie Morrison, Chief Executive Officer of
Cadent Therapeutics. “This deeply underserved patient population
deserves new therapies, and we look forward to advancing CAD-1883, our
therapy that holds great potential for addressing their unmet needs.”

The FDA Office of Orphan Products Development grants Orphan Drug
Designation to drugs and biologics that are defined as those intended
for the safe and effective treatment, diagnosis or prevention of rare
diseases/disorders that affect fewer than 200,000 people in the U.S. The
designation allows Cadent to qualify for a number of incentives,
including seven years of market exclusivity upon regulatory approval, if
received; exemption from FDA application fees for spinocerebellar
ataxia; and tax credits for qualified clinical trials.

About CAD-1883

CAD-1883 is a first-in-class selective positive allosteric modulator of
SK channels (small-conductance, calcium-activated potassium ion
channels) in development for the treatment of movement disorders
including essential tremor (ET) and spinocerebellar ataxia (SCA).

About Spinocerebellar Ataxia

Spinocerebellar ataxia (SCA) is estimated to affect 11,000 people in the
U.S. and an additional 15,500 people in the EU5 and Japan. SCA is a
genetically defined degenerative disease with four identified genotypes
affecting more than 50% of patients with SCA and is characterized by a
progressive loss of coordination, abnormal speech, involuntary eye
moment and cognitive dysfunction. There are no approved treatments
available for SCA.

About Cadent Therapeutics

Cadent Therapeutics is creating therapies for the treatment of movement
disorders and cognitive impairment. The company combines target
specificity, patient selection, drug design and optimization, and novel
quantitative endpoints to create first-in-class molecules to treat
movement and cognitive disorders. Cadent Therapeutics is rapidly
advancing its pipeline of positive allosteric modulators to treat
spinocerebellar ataxia, essential tremor and schizophrenia. The company
has an exclusive license and collaboration agreement with Novartis to
develop a negative allosteric modulator, now in Phase 2 clinical studies
for the treatment of treatment resistant depression. Investors include
Atlas Venture, Cowen Healthcare Investments, Qiming Venture Partners,
Access Industries, Clal Biotechnology Industries, Novartis Institutes
for Biomedical Research and Slater Technology Fund. For more
information, please visit cadenttx.com.

Contacts

Investors:
Maeve Conneighton, [email protected]
212.600.1902

Media:
David
Rosen, [email protected]
212.600.1902