Reduction in Pathological Bone Shape Change Correlates with Decreased Frequency of Knee Pain After TPX-100 Treatment

OAKLAND, Calif.–(BUSINESS WIRE)–#biotechnology–OrthoTrophix, Inc. (www.orthotrophix.com),
a privately-held biopharmaceutical company, announced today new results
from a Phase 2 study of the osteoarthritis drug TPX-100. In subjects
with MRI-confirmed bilateral patellofemoral knee osteoarthritis (OA),
TPX-100 treatment was associated with a statistically significant and
clinically meaningful reduction in frequency of knee pain compared with
placebo. A retrospective MRI-based analysis of three-dimensional bone
shape change, a biomarker of OA disease progression, revealed reduced or
stabilized patellar bone shape change in TPX-100-treated knees compared
with placebo-exposed knees. Based on extensive data from the
Osteoarthritis Initiative, bone shape change is more sensitive than
cartilage thickness measures as a predictor of knee OA progression and
joint failure. At 12 months, reduced patellar bone shape change in
TPX-100-treated knees correlated significantly with reduced pain
frequency (p<0.001). Bone shape analyses were performed by international
leaders in joint structure assessment for knee OA, blind to treatment
assignment and clinical data.

“Knee pain is the most common reason that patients with knee OA seek
medical help,” commented OrthoTrophix’ Chief Medical Officer, Dr. Dawn
McGuire. “The reduction in pain frequency after TPX-100 was robust and
sustained in over 50% of knees treated with TPX-100: from “daily” to
less than weekly at 12 months. In addition, overall analgesic use
declined by more than 60%. Significant correlation between a key
clinical benefit and reduced or stabilized joint pathology provides
support for TPX-100 as a disease-modifying OA drug (DMOAD). We are
excited by these findings and are enthusiastic about further development
of TPX-100 as a first-in-class treatment for patients afflicted with
knee OA.”

About OrthoTrophix, Inc.

OrthoTrophix, Inc., based in Oakland, California, is a privately held
biopharmaceutical company focused on the development and
commercialization of revolutionary therapeutics for the treatment of
diseases and conditions involving the hard tissues. Founded by three
co-founders in 2011, the primary focus of OrthoTrophix has been
regeneration and repair of cartilage in the knee and other joints with
its novel proprietary compounds which promote formation of new cartilage
and bone tissues and thereby repair the respective defects.

This press release contains “forward-looking” statements. These
statements involve risks and uncertainties, which may cause results to
differ materially from those set forth in the statements. The
forward-looking statements include statements regarding product
development and cannot be guaranteed. OrthoTrophix undertakes no
obligation to publicly update any forward-looking statement, whether as
a result of new information, future events, or otherwise.
Forward-looking statements in this press release should be evaluated
together with the many uncertainties that affect OrthoTrophix’ business.

Contacts

Company Contact
Yoshi Kumagai
President and CEO
Tel:
(510) 488-3824