Moleculin Receives Approval from the UK’s Medicines and Healthcare Merchandise Regulatory Company (MHRA) for Protocol Modification to Part 1a Scientific Trial of WP1122 for the Remedy of COVID-19

– Dosing for first-in-human Part 1a research to judge security and pharmacokinetics of WP1122 in wholesome volunteers and set up most tolerated dose anticipated to start imminently –

HOUSTON, Could 10, 2022 /PRNewswire/ — Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Firm”), a medical stage pharmaceutical firm with a broad portfolio of drug candidates concentrating on extremely resistant tumors and viruses, as we speak introduced that it has acquired approval from the United Kingdom’s (UK) MHRA to proceed with a first-in-human Part 1a research to judge the protection and pharmacokinetics of WP1122 in wholesome volunteers for the remedy of COVID-19 (MB-301). The approval follows Moleculin’s having submitted a protocol modification permitting for a better ratio of diluting excipients to drug substance to facilitate a quicker and easier mixing process earlier than drug administration.

Moleculin Biotech, Inc. is a medical stage pharmaceutical firm targeted on the event of a broad portfolio of oncology drug candidates for the remedy of extremely resistant tumors. (PRNewsfoto/Moleculin Biotech, Inc.)

Walter Klemp, Chairman and Chief Executive Officer of Moleculin commented, “Approval of the protocol modification from the MHRA is one other encouraging step ahead. We imagine the antiviral impact demonstrated by WP1122 in preclinical fashions to-date means that the drug could have the potential to satisfy the crucial want for a pan-viral remedy that would deal with not solely COVID-19 and its variants, but in addition different viruses that trigger human illness. As we’re additionally growing this drug for human cancers, this Part 1 trial may present info that helps advance our most cancers analysis. We stay dedicated to advancing the event of WP1122 and sit up for the graduation of dosing in wholesome volunteers, which we anticipate later this month.”

WP1122, the Firm’s lead metabolism/glycosylation inhibitor, is a prodrug of a widely known glucose decoy known as 2-deoxy-D-glucose (2-DG), presently being developed for inhibition of viral replication and illness manifestations in people contaminated with SARS-CoV-2, the virus answerable for COVID-19. The mechanism of motion of 2-DG consists of each the inhibition of glycolysis and the disruption of glycosylation, two processes which might be vital to each viral exercise and tumor improvement. WP1122 was developed as a 2-DG prodrug to offer a extra favorable pharmacological profile, and was discovered to have higher efficiency than 2-DG alone in preclinical fashions the place tumor cells require greater glycolytic exercise than regular cells. WP1122 has additionally been proven to have a stronger antiviral impact than 2-DG towards SARS-CoV-2 in MRC-5 cells (one of the vital frequent human-derived cell strains used for antiviral analysis) in tradition.

The Part 1a research in wholesome human volunteers will examine the consequences of a single ascending dose (SAD) and a number of days of ascending dosing (MAD) of WP1122 administered as an oral resolution. Dose escalation will happen in sequential SAD cohorts, and MAD will begin as quickly as SAD has accomplished at the least 3 dosing cohorts by which WP1122 is discovered to be protected and well-tolerated. This research in wholesome volunteers will discover security and pharmacokinetics (PK), and subsequent medical improvement shall be in sufferers contaminated with SARS-CoV-2 to additional consider security and set up a good threat/profit profile. The Firm expects to enroll roughly 80 wholesome volunteers within the United Kingdom.

For extra details about the research, please go to clinicaltrials.gov and reference identifier NCT05195723. Moleculin Biotech can be within the technique of figuring out further international locations the place potential future Part 2 COVID-19 medical research may happen.

About WP1122

WP1122 was developed as a 2-DG prodrug to offer a extra favorable pharmacological profile and was discovered to have higher efficiency than 2-DG alone in preclinical fashions the place tumor cells require greater glycolytic exercise than regular cells. WP1122 has additionally been proven to have a higher antiviral impact than 2-DG towards SARS-CoV-2 in MRC-5 cells in tradition. The improved pharmacokinetic and pharmacodynamic (PK/PD) profile of WP1122 in comparison with 2-DG was famous in feminine mice following oral dosing at equimolar (i.e., equal ranges of 2-DG) doses.

The Firm can be within the technique of figuring out further international locations the place potential future Part 2 COVID-19 medical research may happen, though the volatility and unpredictability of COVID-19 incidence in numerous international locations could restrict the flexibility to recruit sure topics and will make it infeasible to conduct a Part 2 medical trial there. Moreover, Moleculin not too long ago acquired IND clearance from the U.S. Meals and Drug Administration (FDA) to provoke a Part 1 research of WP1122 for the remedy of Glioblastoma Multiforme (GBM), which the Firm expects to start in 2022.

About Moleculin Biotech, Inc.

Moleculin Biotech, Inc. is a medical stage pharmaceutical firm targeted on the event of a broad portfolio of drug candidates for the remedy of extremely resistant tumors and viruses. The Firm’s lead program, Annamycin is a next-generation anthracycline designed to keep away from multidrug resistance mechanisms with little to no cardiotoxicity. Annamycin is presently in improvement for the remedy of relapsed or refractory acute myeloid leukemia (AML) and gentle tissue sarcoma (STS) lung metastases.

Moreover, the Firm is growing WP1066, an Immune/Transcription Modulator able to inhibiting p-STAT3 and different oncogenic transcription components whereas additionally stimulating a pure immune response, concentrating on mind tumors, pancreatic and different cancers, and WP1220, an analog to WP1066, for the topical remedy of cutaneous T-cell lymphoma. Moleculin can be engaged within the improvement of a portfolio of antimetabolites, together with WP1122 for the potential remedy of COVID-19 and different viruses, in addition to most cancers indications together with mind tumors, pancreatic and different cancers.

For extra details about the Firm, please go to www.moleculin.com and join on Twitter, LinkedIn and Facebook.

Ahead-Wanting Statements

A number of the statements on this launch are forward-looking statements throughout the that means of Part 27A of the Securities Act of 1933, Part 21E of the Securities Alternate Act of 1934 and the Personal Securities Litigation Reform Act of 1995, which contain dangers and uncertainties. Ahead-looking statements on this press launch embrace, with out limitation, the graduation date of the Part 1a research, whether or not the outcomes of Moleculin’s preclinical fashions will be replicated in human trials, and Moleculin’s potential to establish further international locations the place potential future Part 2 COVID-19 medical research may happen. Though Moleculin believes that the expectations mirrored in such forward-looking statements are affordable as of the date made, expectations could show to have been materially completely different from the outcomes expressed or implied by such forward-looking statements. Moleculin has tried to establish forward-looking statements by terminology together with ‘believes,’ ‘estimates,’ ‘anticipates,’ ‘expects,’ ‘plans,’ ‘tasks,’ ‘intends,’ ‘potential,’ ‘could,’ ‘may,’ ‘would possibly,’ ‘will,’ ‘ought to,’ ‘roughly’ or different phrases that convey uncertainty of future occasions or outcomes to establish these forward-looking statements. These statements are solely predictions and contain identified and unknown dangers, uncertainties, and different components, together with these mentioned beneath Merchandise 1A. “Danger Components” in our most not too long ago filed Type 10-Okay filed with the Securities and Alternate Fee (“SEC”) and up to date sometimes in our Type 10-Q filings and in our different public filings with the SEC. Any forward-looking statements contained on this launch converse solely as of its date. We undertake no obligation to replace any forward-looking statements contained on this launch to mirror occasions or circumstances occurring after its date or to mirror the incidence of unanticipated occasions.

Investor Contact:

JTC Group, LLC
Jenene Thomas
(833) 475-8247
[email protected]

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