Diffusion Pharmaceuticals Reports Positive Trend in Oxygenation from TCOM Trial
June 30 2021 - 6:35AM
Diffusion Pharmaceuticals Inc. (NASDAQ:
DFFN) (“Diffusion” or the “Company”), an innovative
biopharmaceutical company developing novel therapies that enhance
the body’s ability to deliver oxygen to areas where it is needed
most, today announced topline results from the Company’s Phase 1
trial of its lead product candidate, trans sodium crocetinate
(“TSC”).
In this trial, transcutaneous oxygen monitoring
(“TCOM”) was used to measure the direct pharmacodynamic effects of
TSC on peripheral tissue oxygenation in healthy normal volunteers.
Topline results were based upon analyses of primary endpoint data,
which indicate, as compared to placebo, a positive dose-response
trend in TCOM readings after TSC administration that persisted
through the measurement period. Due in part to the small number of
healthy subjects in each cohort, and the inherent variability of
tcpO2 measurement, the magnitude of effect was not statistically
significant; however, the trends in the primary endpoint data
indicated an improvement in peripheral oxygenation compared to
placebo, with no evidence of hyperoxygenation. Furthermore, TSC was
safe and well-tolerated at all doses tested with no serious adverse
events or dose-limiting toxicities.
“The positive trend observed in the TCOM trial
is very encouraging,” said Chris Galloway, M.D., Diffusion’s Chief
Medical Officer. "We believe the data further clarify TSC’s
exposure-response relationship and successfully build on our
clinical development strategy. These data will inform study design
for upcoming trials and our ongoing investigation of the timing of
administration to maximize clinical efficacy. We also believe the
TCOM data complement recent data obtained from our COVID-19 trial
and further support our ongoing execution of our three
well-controlled Oxygenation Trials, where each study is uniquely
designed to differentially investigate TSC’s novel mechanism of
action. We expect the individual and collective data from these
studies will inform our late phase programs and clinical
indications to pursue for commercialization of TSC.”
The TCOM Trial was the first of three
Oxygenation Trials the Company plans to conduct in 2021. The
designs of these studies are as follows:
Oxygenation Trial Designs
- TCOM
Trial: This recently completed clinical trial was a
randomized, double-blind, placebo controlled, pharmacokinetic and
pharmacodynamic study of TSC that enrolled and dosed 30 healthy
volunteers. Trial participants were randomized into one of six
subgroups, each of which received a single intravenous dose of
placebo or one of five different doses of TSC ranging from 0.5
mg/kg to 2.5 mg/kg. All trial participants received supplemental
oxygen during equivalent monitoring periods before and after TSC or
placebo was administered while being continuously monitored with
TCOM sensors applied to the lower extremity. The primary endpoint
evaluated the relative change in TCOM readings from baseline after
TSC administration compared to placebo.
-
Altitude Trial (induced hypoxia): This trial will
be a double-blind, randomized, placebo-controlled study which will
evaluate the effects of TSC on maximal oxygen consumption, or VO2,
and partial pressure of blood oxygen, or PaO2, in normal healthy
volunteers subjected to incremental levels of physical exertion
while exposed to hypoxic and hypobaric conditions (i.e., simulated
altitude). The trial will evaluate the difference in effect of TSC
on oxygen availability and consumption.
- DLCO Trial: This
trial will be a double-blind, randomized, placebo-controlled study
which will evaluate the effects of TSC on the diffusion of carbon
monoxide through the lungs (DLCO) in patients with previously
diagnosed interstitial lung disease who have an abnormal baseline
DLCO test result. DLCO will act as a surrogate measure of oxygen
transfer efficiency, or uptake, from the alveoli of the lungs,
through the plasma, and onto hemoglobin within red blood cells. The
study will evaluate the difference in effect of TSC on improvement
in DLCO, as well as distance covered in a standard six-minute walk
test.
Diffusion anticipates initiating and completing
the DLCO and Altitude Trials in the second half of 2021, with
topline results from each study available within two months of
their respective completion. These results will further guide the
selection of indications and doses to be pursued for future
development of TSC. In the fourth quarter of 2021, the Company
expects to announce the initial hypoxia-related indications in
which TSC would be studied as part of its clinical development
strategy aimed at supporting regulatory approval and, if approved,
commercialization. Diffusion intends to initiate clinical studies
in the identified indications during the first half of 2022.
“It is exciting to see the effects on
oxygenation in the TCOM study. These results along with the other
two Oxygenation Trials form the cornerstone of our revised TSC
development strategy implemented over the last nine months,” said
Robert Cobuzzi, Jr., Ph.D., President and CEO of Diffusion. “We are
executing well as a team, meeting our stated commitments and we
continue to evolve as an organization.”
About Diffusion Pharmaceuticals Inc.
Diffusion Pharmaceuticals Inc. is an innovative
biopharmaceutical company developing novel therapies that enhance
the body’s ability to deliver oxygen to areas where it is needed
most. Diffusion’s lead product candidate, TSC, is being developed
to enhance the diffusion of oxygen to tissues with low oxygen
levels, also known as hypoxia, a serious complication of many of
medicine’s most intractable and difficult-to-treat conditions. In
addition to TSC, Diffusion’s product candidate DFN-529, a novel,
allosteric PI3K/Akt/mTOR Pathway inhibitor, is in early-stage
development. For more information, please visit us at
www.diffusionpharma.com.
Forward-Looking Statements
This press release includes express and implied
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995, as amended, including
regarding the Company’s near-term strategic priorities, anticipated
timelines for the initiation, completion, and announcement of data
from the Company’s ongoing and planned oxygenation trials, and the
potential therapeutic value of TSC. The Company may, in some cases,
use terms such as “believes,” “estimates,” “anticipates,”
“expects,” “plans,” “intends,” “may,” “could,” “might,” “will,”
“should,” “approximately,” or other words that convey uncertainty
of future events or outcomes to identify these forward-looking
statements. Although the Company believes that it has a reasonable
basis for each forward-looking statement contained herein,
forward-looking statements by their nature involve risks and
uncertainties, known and unknown, many of which are beyond the
Company’s control, and as a result, the Company’s actual results
could differ materially from those expressed or implied in any
forward-looking statement. Particular risk and uncertainties
include, among other things, those related to: the completion of
the full analyses of the data from the TCOM Trial, including
secondary endpoint data; the Company’s ability to design, initiate,
enroll, execute, and complete its ongoing and planned studies
evaluating TSC; the optimal doses and dosing regimens of TSC in
connection with the potential treatment of any particular disease
or indication; general economic, political, business, industry, and
market conditions, including the ongoing COVID-19 pandemic; and the
other factors discussed under the heading “Risk Factors” in the
Company’s filings most recent Annual Report on Form 10-K and other
filings with the U.S. Securities and Exchange Commission. Any
forward-looking statements in this press release speak only as of
the date hereof (or such earlier date as may be identified) and,
except as required by applicable law, rule, or regulation, the
Company undertakes no obligation to update any such statements
after the date hereof.
ContactsInvestors: Tiberend
Strategic Advisors, Inc. Maureen McEnroe, CFA / Lisa
Sher mmcenroe@tiberend.com / lsher@tiberend.com
Media: Kate
BarretteRooneyPartners (212)
223-0561Kbarrette@rooneypartners.com
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