Diffusion Pharmaceuticals Completes Enrollment and Dosing in TCOM Study
March 25 2021 - 9:01AM
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 it has completed enrollment and dosing of all
participants in the Company’s Phase 1 trial of its novel, oxygen
enhancing therapeutic, trans sodium crocetinate (“TSC”), utilizing
a transcutaneous oxygen monitoring (TCOM) device to evaluate the
pharmacodynamic effects of TSC on peripheral tissue oxygenation.
The TCOM trial is the first in a series of three short-term
Oxygenation Trials that Diffusion plans to conduct in the United
States in 2021. Together, these Oxygenation Trials will serve as a
prospective exploration of the relationship between the level of
TSC exposure (dose) and response (change in oxygenation) and the
Company expects positive data from any of the three Oxygenation
Trials, if obtained, will guide the next phases of TSC’s clinical
development and commercialization plans. The Company intends to
fund these three studies with cash-on-hand.
The TCOM 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 and each received a single
intravenous dose of placebo or one of five different doses of TSC
ranging from 0.5-2.5 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 evaluates the relative change in TCOM readings
from baseline after TSC administration. Diffusion anticipates that
the ongoing collection and analyses of the TCOM trial data will be
completed and announced in the second quarter of 2021.
“We expect the results of the TCOM trial to provide important
information about TSC’s ability to enhance oxygen delivery to
tissues, while further clarifying dose and duration of effects,”
said Christopher Galloway, M.D., Chief Medical Officer of
Diffusion. “I am ever grateful to the volunteers and thrilled that
the trial was able to fully enroll so quickly. We now eagerly await
the objective analysis of the trial, recognizing we have two other
Oxygenation Trials yet to be conducted this year.”
Near-term Clinical StrategyIn addition to the
TCOM trial, the Company plans to initiate the following two,
additional Oxygenation Trials in the third quarter of 2021:
- Hypoxia
Trial: This is expected to 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.
- DLCO Trial: This is
expected to be a double-blind, randomized, placebo-controlled study
which will evaluate the effects of TSC on the diffusion of carbon
monoxide through the lungs, also known as DLCO, in patients with
previously diagnosed interstitial lung disease who have a baseline
DLCO test result that is abnormal. 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 Company expects positive data from any of the three
Oxygenation Trials will drive the next steps in the TSC clinical
development strategy, which is focused on demonstrating the
therapeutic value of TSC in an applicable patient population
affected by hypoxia. Assuming success in any one or more of the
Oxygenation Trials, Diffusion expects to identify and announce the
specific, hypoxia-related indication(s) on which it will focus
further clinical development in the fourth quarter of 2021. The
Company then plans to initiate a Phase 2 clinical outcome study
evaluating TSC in the announced indication(s), during the first
quarter of 2022.
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 StatementsThis
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
anticipated cash runway, its near-term strategic priorities, and
anticipated timelines for the initiation, completion, and
announcement of data from the Company’s ongoing and planned
oxygenation trials. 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 Company’s ability to design, initiate,
enroll, execute, and complete its ongoing and planned studies
evaluating TSC; 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/Miriam Weber
Miller (212) 375-2664 / (212)
375-2694 mmcenroe@tiberend.com / mmiller@tiberend.com
Media: Jeffrey
Freedman RooneyPartners (646)
432-0191 jfreedman@rooneyco.com
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