Diffusion Pharmaceuticals Announces Clearance of IND Application for TSC by FDA’s Pulmonology, Allergy, and Critical Care Division
Diffusion Pharmaceuticals (NASDAQ: DFFN) has received FDA clearance for an Investigational New Drug (IND) application for its lead candidate, trans sodium crocetinate (TSC), aimed at treating Interstitial Lung Disease (ILD). This marks the fourth IND clearance for TSC across various FDA divisions, reflecting its broad therapeutic potential. A Phase 2 clinical trial will evaluate TSC’s efficacy in enhancing oxygen diffusion in ILD patients, set to commence in Q4 2021. Results will influence the selection of TSC’s dosing regimen and its initial lead indication, expected by year-end 2021.
- FDA clearance of IND for TSC enhances regulatory opportunities.
- Initiation of Phase 2 ILD-DLCO trial expected in Q4 2021, indicating progress in development.
- No immediate financial metrics or outcomes provided for trial results.
- Regulatory uncertainties associated with future approvals of TSC.
Phase 2 DLCO Trial in Interstitial Lung Disease Expected to Begin in Q4 Under New IND
Fourth FDA Division to Clear TSC IND
CHARLOTTESVILLE, Va., Aug. 30, 2021 (GLOBE NEWSWIRE) -- 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 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 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.
Contacts
Investors:
Tiberend Strategic Advisors, Inc.
Maureen McEnroe, CFA / Lisa Sher
mmcenroe@tiberend.com / lsher@tiberend.com
Media:
Kate Barrette
RooneyPartners
(212) 223-0561
Kbarrette@rooneypartners.com
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