Diffusion Pharmaceuticals Announces Clearance of IND Application for TSC by FDA’s Pulmonology, Allergy, and Critical Care Division
August 30 2021 - 7:32AM
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 the Company has obtained clearance of
its Investigational New Drug (IND) application submitted to the
U.S. Food and Drug Administration’s (FDA) Pulmonology, Allergy, and
Critical Care Division for the company’s lead product candidate,
trans sodium crocetinate (TSC). Diffusion now has open INDs related
to TSC with four FDA divisions-- Pulmonology, Allergy, and Critical
Care; Cardiology and Nephrology; Neurology; and Oncology -- which
the Company believes further supports TSC’s broad therapeutic
potential.
The previously announced trial to be conducted
under the most recent IND will be a Phase 2, double-blind,
randomized, placebo-controlled study, which will evaluate the
effects of TSC in patients with Interstitial Lung Disease (ILD) on
the diffusion of carbon monoxide through the lungs, or DLCO, as
well as functional change in the patient’s 6-minute walk test. The
ILD-DLCO trial will be the third of Diffusion’s three Oxygenation
Trials. These Oxygenation Trials were designed to further clarify
both dose and duration of clinical effect to assess the ability of
TSC to enhance oxygen uptake, peripheral oxygenation, and
consumption. The results of these Oxygenation Trials will inform
the selection of TSC’s dosing regimen and initial lead indication,
which will be selected and communicated by year-end 2021, with a
resulting clinical study expected to be initiated in the first half
of 2022.
Chris Galloway, M.D., CMO of Diffusion, stated,
“The clearance of our new IND within the Pulmonary Division is a
great milestone for Diffusion and TSC. Not only does it give us the
ability to conduct the ILD-DLCO trial in the U.S., but also expands
our potential regulatory opportunities across multiple divisions at
the FDA encompassing numerous therapeutic areas. In parallel, we
are actively engaged with our partners preparing for study start up
with the expectation to dose the first ILD patients in this Phase 2
ILD-DLCO Trial during the fourth quarter of this year. We believe
clearance of this fourth IND by the FDA speaks to the broad
applicability of TSC across a myriad of indications that are
complicated by hypoxia where TSC could be a part of multi-modal
therapy with the goal of improving patient outcomes.”
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
near-term strategic priorities, anticipated timelines for the
initiation of the Company’s 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 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; the regulatory approval
process for 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 / Lisa
Sher mmcenroe@tiberend.com / lsher@tiberend.com
Media: Kate
BarretteRooneyPartners(212)
223-0561Kbarrette@rooneypartners.com
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