Diffusion Pharmaceuticals Doses First Participants in TCOM Study
March 18 2021 - 7:05AM
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 that it has dosed the first 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
effects of TSC on peripheral tissue oxygenation.
The TCOM trial is the first in a series of three, short-term
studies Diffusion plans to conduct in the United States in 2021.
Together, the oxygenation trials, which the Company plans to fund
with cash-on-hand, will serve as a prospective exploration of the
relationship between the level of TSC exposure (dose) and response
(change in oxygenation). The results will be used to inform the
next phases of clinical development and commercialization
plans.
The TCOM trial is a randomized, double blind, placebo
controlled, pharmacokinetic, pharmacodynamic study of TSC that will
enroll up to 30 healthy volunteers. Trial participants will be
randomized into one of six subgroups and receive a single
intravenous dose of TSC or placebo. Patients receiving TSC will be
randomly assigned to receive one of five different doses ranging
from 0.5-2.5 mg/kg. All trial participants will receive
supplemental oxygen during equivalent monitoring periods before and
after TSC is administered while being continuously monitored with
transcutaneous oximetry sensors applied to the lower extremity. The
primary endpoint will be the change in TCOM readings after TSC
administration relative to the participants pre-dose baseline TCOM
readings. Diffusion anticipates that the TCOM trial will be
completed in 2Q21.
“We anticipate the TCOM trial will provide important information
about TSC’s ability to enhance oxygen delivery to tissues,” said
Christopher Galloway, M.D., Chief Medical Officer of Diffusion. “We
are excited to obtain objective evidence of the drug’s
exposure-response relationship with oxygenation and eager to
incorporate that knowledge into the next phase of our clinical
development strategy.”
Near-term Clinical StrategyIn addition to the
TCOM trial, the Company plans two additional oxygenation trials as
follows:
- 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.
Diffusion plans to initiate both of these studies in 3Q21.
The Company anticipates that positive data from one or more of
the three oxygenation trials will guide the next steps in the TSC
clinical development strategy, which will focus on demonstrating
the therapeutic benefits of TSC in a relevant patient population
affected by hypoxia. The Company expects to identify and announce
this specific, hypoxia-related indication on which it will focus
further clinical development in 4Q21. The Company then plans to
initiate a Phase 2 clinical outcome study evaluating TSC in the
announced indication, 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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