Moleculin Receives Approval from the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) for Protocol Amendment to Phase 1a Clinical Trial of WP1122 for the Treatment of COVID-19 & More News Here

 

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

HOUSTON, May 10, 2022 /PRNewswire/ — Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a scientific stage pharmaceutical firm with a broad portfolio of drug candidates concentrating on extremely resistant tumors and viruses, in the present day introduced that it has acquired approval from the United Kingdom’s (UK) MHRA to proceed with a first-in-human Phase 1a examine to consider the security and pharmacokinetics of WP1122 in wholesome volunteers for the therapy 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 sooner and easier mixing process earlier than drug administration.

Walter Klemp, Chairman and Chief Executive Officer of Moleculin commented, “Approval of the protocol amendment from the MHRA is another encouraging step forward. We believe the antiviral effect demonstrated by WP1122 in preclinical models to-date suggests that the drug may have the potential to meet the critical need for a pan-viral therapy that could address not only COVID-19 and its variants, but also other viruses that cause human disease. As we are also developing this drug for human cancers, this Phase 1 trial may also provide information that helps advance our cancer research. We remain committed to advancing the development of WP1122 and look forward to the commencement of dosing in healthy volunteers, which we expect later this month.”

WP1122, the Company’s lead metabolism/glycosylation inhibitor, is a prodrug of a widely known glucose decoy known as 2-deoxy-D-glucose (2-DG), at present being developed for inhibition of viral replication and illness manifestations in people contaminated with SARS-CoV-2, the virus accountable for COVID-19. The mechanism of motion of 2-DG contains each the inhibition of glycolysis and the disruption of glycosylation, two processes which might be essential to each viral exercise and tumor improvement. WP1122 was developed as a 2-DG prodrug to present a extra favorable pharmacological profile, and was discovered to have better 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 commonest human-derived cell strains used for antiviral analysis) in tradition.

The Phase 1a examine in wholesome human volunteers will examine the results 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 not less than 3 dosing cohorts through which WP1122 is discovered to be secure and well-tolerated. This examine in wholesome volunteers will discover security and pharmacokinetics (PK), and subsequent scientific improvement will likely be in sufferers contaminated with SARS-CoV-2 to additional consider security and set up a good danger/profit profile. The Company expects to enroll roughly 80 wholesome volunteers in the United Kingdom.

For extra details about the examine, please go to clinicaltrials.gov and reference identifier NCT05195723. Moleculin Biotech can be in the course of of figuring out extra international locations the place potential future Phase 2 COVID-19 scientific research might happen.

About WP1122

WP1122 was developed as a 2-DG prodrug to present a extra favorable pharmacological profile and was discovered to have better 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 better 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 contrast to 2-DG was famous in feminine mice following oral dosing at equimolar (i.e., equal ranges of 2-DG) doses.

The Company can be in the course of of figuring out extra international locations the place potential future Phase 2 COVID-19 scientific research might happen, though the volatility and unpredictability of COVID-19 incidence in numerous international locations could restrict the means to recruit sure topics and might make it infeasible to conduct a Phase 2 scientific trial there. Additionally, Moleculin just lately acquired IND clearance from the U.S. Food and Drug Administration (FDA) to provoke a Phase 1 examine of WP1122 for the therapy of Glioblastoma Multiforme (GBM), which the Company expects to start in 2022.

About Moleculin Biotech, Inc.

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

Additionally, the Company is creating WP1066, an Immune/Transcription Modulator succesful of 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 therapy of cutaneous T-cell lymphoma. Moleculin can be engaged in the improvement of a portfolio of antimetabolites, together with WP1122 for the potential therapy 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 Company, please go to www.moleculin.com and join on Twitter, LinkedIn and Facebook.

Forward-Looking Statements

Some of the statements on this launch are forward-looking statements inside the that means of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which contain dangers and uncertainties. Forward-looking statements on this press launch embody, with out limitation, the graduation date of the Phase 1a examine, whether or not the outcomes of Moleculin’s preclinical fashions might be replicated in human trials, and Moleculin’s means to determine extra international locations the place potential future Phase 2 COVID-19 scientific research might happen. Although 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 determine forward-looking statements by terminology together with ‘believes,’ ‘estimates,’ ‘anticipates,’ ‘expects,’ ‘plans,’ ‘tasks,’ ‘intends,’ ‘potential,’ ‘could,’ ‘might,’ ‘may,’ ‘will,’ ‘ought to,’ ‘roughly’ or different phrases that convey uncertainty of future occasions or outcomes to determine these forward-looking statements. These statements are solely predictions and contain recognized and unknown dangers, uncertainties, and different components, together with these mentioned beneath Item 1A. “Risk Factors” in our most just lately filed Form 10-Okay filed with the Securities and Exchange Commission (“SEC”) and up to date from time to time in our Form 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 Team, LLC
Jenene Thomas

(833) 475-8247
[email protected] 

 

 

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SOURCE Moleculin Biotech, Inc.

 

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