twoXAR Announces Preclinical Proof-of-Concept Data on Type 2 Diabetes Candidate

Study demonstrates the power of artificial intelligence-enabled
approaches in accelerating early-stage drug discovery for new treatments
in type 2 diabetes

PALO ALTO, Calif.–(BUSINESS WIRE)–#AI–twoXAR, Inc., an artificial intelligence (AI)-driven biopharmaceutical
company, today announced that its candidate, TXR-411, has shown
promising results in the db/db mouse model of type 2 diabetes (T2DM).
TXR-411 is a molecule that twoXAR identified as having a high
probability of being effective in treating T2DM. Proof-of-concept
studies in the db/db mouse model were performed by Melior Discovery, a
leading research provider of preclinical services that previously
achieved positive Phase 2A results with its first-in-class T2DM drug,
MLR-1023. The objective of these studies was to further demonstrate
proof of concept of twoXAR’s AI platform as a discovery engine capable
of uncovering new therapies across a diversified set of diseases.

“The TXR-411 data in the db/db model is impressive given that the
initial examination of our candidate achieved an approximately 50
percent decrease in glucose levels, on par with rosiglitazone, without
the weight gain associated with rosiglitazone,” said Isaac Hakim, Ph.D,
Director of Preclinical Studies at twoXAR. “The reduced glucose and body
weight maintenance is exciting in its own right, however, even more
compelling is that we selected this disease, identified and shortlisted
candidates, and generated efficacious preclinical results in less than
three months.”

Nearly four hundred million patients suffer from T2DM globally, and the
market size is expected to double by 2025. Given the complex and
multifactorial origin of T2DM there remains a high unmet need for novel
therapies that work by new mechanisms. Peroxisome Proliferator-Activated
Receptor (PPAR) agonists, such as rosiglitazone, were once the leading
therapeutic class (commercially) but have since largely been
discontinued due to initially unrecognized safety issues. Diabetic
therapies which target novel biological pathways may help to reduce the
risk of common side effects while improving levels of efficacy. In
addition, combination therapies of two and three complementary
therapeutics are standard practice and further increase the need for new
antidiabetic mechanisms.

Using a clinically translatable model of T2DM (db/db mice), the data
showed that TXR-411 significantly reduced blood glucose levels and
improved the results of oral glucose tolerance as effectively as
rosiglitazone. These results were achieved without any of the weight
gain that is associated with PPAR agonists like rosiglitazone. Seeing
potentially promising results in the db/db model is meaningful as this
model incorporates many aspects of human T2DM including hyperglycemia,
obesity, and impaired beta-cell function.

“Over the last 12 months we have publicly announced positive preclinical
proof-of-concept data in rheumatoid arthritis, liver cancer, and now
type 2 diabetes,” said Andrew A. Radin, co-founder and CEO of twoXAR.
“Across these studies we have seen that about 30 percent of the novel
candidates we test in preclinical studies show statistically significant
efficacy signals in the in vivo models’ respective endpoints.”

twoXAR computationally screened a library of more than 25,000 potential
drug candidates. The three with the strongest evidence for potential
efficacy and safety were selected for these studies. Each candidate was
identified using twoXAR’s computational drug discovery platform which
utilizes artificial intelligence to rapidly perform unbiased analyses of
biological, chemical, and clinical data to predict and rank potentially
efficacious drugs. This strategy offers a new route to unique
intellectual property rights that allow for the rapid development of a
drug while maximizing the opportunity to identify the most efficacious
molecule.

Preclinical studies were conducted by researchers at Melior Discovery,
under the direction of John Ciallella, Ph.D, Director of Research at
Melior Discovery and Melior Pharmaceuticals.

About twoXAR

twoXAR is an artificial intelligence-driven biopharmaceutical company.
The company leverages its computational platform to identify promising
drug candidates, de-risks the opportunities through preclinical studies,
and progresses drug candidates to the clinic through industry
partnerships. Based in Palo Alto, California, the twoXAR team includes
experts in drug discovery and development, biomedical informatics,
computational biology, data science and software development. For more
information please visit, www.twoXAR.com.

Contacts

for twoXAR, Inc.
Colin Sanford, 415-946-1094
csanford@purecommunications.com