Imago BioSciences Announces First Participant Dosed in Investigator-Sponsored Phase 2 Study of Bomedemstat in Combination with Ruxolitinib in Myelofibrosis

Rhea-AI Summary

Imago BioSciences (IMGO) has initiated a Phase 2 study for bomedemstat, an oral LSD1 inhibitor, in combination with ruxolitinib to treat myelofibrosis (MF). This investigator-sponsored trial, conducted at the University of Hong Kong, will enroll around 20 participants with varying responses to JAK inhibitors. The study aims to evaluate the safety and efficacy of this combination therapy over 28-day treatment cycles. Bomedemstat is already showing promise in ongoing studies, demonstrating significant symptom improvement in patients with MF and essential thrombocythemia.

Positive

• Initiation of Phase 2 study for bomedemstat in combination with ruxolitinib.
• Study involves participants with inadequate symptom relief from current treatments.
• Ongoing studies show bomedemstat is generally well-tolerated and improves symptoms.

Negative

• None.

REDWOOD CITY, Calif., Dec. 20, 2022 (GLOBE NEWSWIRE) -- Imago BioSciences, Inc. (“Imago” or the “Company”) (Nasdaq: IMGO), a clinical-stage biopharmaceutical company discovering and developing new medicines for the treatment of myeloproliferative neoplasms (MPNs) and other bone marrow diseases, today announced that the first participant has been dosed in an investigator-sponsored Phase 2 study of bomedemstat, an investigational oral lysine-specific demethylase 1 (LSD1) inhibitor, in combination with ruxolitinib (Jakafi^®) in people with myelofibrosis (MF). Ruxolitinib is a kinase inhibitor approved by the U.S. Food and Drug Administration (FDA) for multiple indications, including the treatment of intermediate or high-risk MF.

The Phase 2 open-label study is being conducted at the Department of Medicine, Queen Mary Hospital and the University of Hong Kong and led by Harinder Gill, M.D. It will enroll approximately 20 participants diagnosed with MF who are either JAK inhibitor naïve or refractory to, relapsed or intolerant of ruxolitinib to assess the safety and efficacy of bomedemstat in combination with ruxolitinib. Treatment cycles will last for 28 days, consisting of an oral administration of both bomedemstat and ruxolitinib once daily.

“We are excited that the University of Hong Kong has interest in exploring the potential use of bomedemstat in combination with ruxolitinib for the treatment of myelofibrosis,” said Hugh Y. Rienhoff, Jr., M.D., Chief Executive Officer of Imago BioSciences. “Bomedemstat, through the inhibition of LSD1, regulates stem cell activity as well as the maturation of megakaryocytes, both of which are key to the pathophysiology of MF. This study explores the possibility that this new combination regimen will serve as a treatment option for patients who have had inadequate symptom relief or spleen volume reduction with ruxolitinib alone.”

In ongoing Phase 2 studies, bomedemstat has been generally well-tolerated and has demonstrated significant symptom improvement for patients with myelofibrosis and essential thrombocythemia. Additional information about the study can be found at www.clinicaltrials.gov using the identifier NCT05569538.

About Imago BioSciences

Imago BioSciences is a clinical-stage biopharmaceutical company discovering and developing novel small molecule product candidates that target lysine-specific demethylase 1 (LSD1), an enzyme that plays a central role in the production of blood cells in the bone marrow. Imago is focused on improving the quality and length of life for patients with cancer and bone marrow diseases. Bomedemstat, an orally available, small molecule inhibitor of LSD1, is the lead product candidate discovered by Imago for the treatment of certain myeloproliferative neoplasms (MPNs), a family of related, chronic cancers of the bone marrow. Imago is evaluating bomedemstat as a potentially disease-modifying therapy in two Phase 2 clinical trials for the treatment of essential thrombocythemia (NCT04254978) and myelofibrosis (NCT03136185). Bomedemstat has U.S. FDA Orphan Drug and Fast Track Designation for the treatment of ET and MF, European Medicines Agency (EMA) Orphan Designation for the treatment of ET and MF, and PRIority MEdicines (PRIME) Designation by the EMA for the treatment of MF. The Company is based in Redwood City, California. To learn more, visit www.imagobio.com, www.myelofibrosisclinicalstudy.com, www.etclinicalstudy.com and follow us on Twitter @ImagoBioRx, Facebook and LinkedIn.

Forward Looking Statements

All statements, other than statements of historical facts, contained in this press release, including statements regarding the results, conduct, progress and timing of Imago clinical trials, the regulatory approval path for bomedemstat, and plans for future operations and information related to Imago, are forward-looking statements. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. These risks and uncertainties include, but are not limited to, Imago’s limited operating history and lack of products for commercial sale; Imago’s dependence on development, regulatory approval and commercialization of its product candidates; difficulties in enrolling patients and risks of substantial delays in its clinical trials; Imago’s minimal control over product candidates in investigator-initiated clinical trials; uncertainties in the cost and outcomes of its clinical studies and the acceptance for presentation at medical meetings of data from such clinical studies; uncertainties in the regulatory review and approval of Imago’s product candidates if its pivotal studies are positive; potentially material changes to the interim, top-line and preliminary data from its clinical trials; potential undesirable effects of Imago’s product candidates and safety or supply issues, in each case with respect to its product candidates alone or in combination with other compounds or products; Imago’s potential inability to obtain and maintain orphan drug designation and delays in approvals despite FDA Fast Track designation for expedited review; risks related to clinical trials outside of the United States; Imago’s need to manufacture adequate supplies, including multiple batches of bomedemstat, using a commercial current Good Manufacturing Practice; risks related to information technology system and cybersecurity; risks related to misconduct of Imago’s employees and independent contractors; risks related to hazardous materials and Imago’s compliance with environmental laws and regulations; risks related to litigation and other claims; risks related to reliance on third parties to conduct and support preclinical studies and clinical trials, and to manufacture Imago’s product candidates; risks related to third-party intellectual property infringement claims and Imago’s ability to protect its own intellectual property; risks related to governmental policies and regulations, including with respect to drug prices and reimbursement, and changes thereof.

Further descriptions of risks and uncertainties relating to Imago can be found in Imago’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2022, its Annual Report on Form 10-K for the year ended December 31, 2021 and subsequent Current Reports on Form 8-K, all of which are filed with the SEC and available at www.sec.gov and https://ir.imagobio.com/financial-information/sec-filings.

You should not place undue reliance on any forward-looking statements. Forward-looking statements should not be read as a guarantee of future performance or results and will not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved, if at all. Except as required by law, Imago does not undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.

Contacts:
Media Contact:
Will Zasadny
Evoke Canale
will.zasadny@evokegroup.com

Investor Contact:
Laurence Watts
Gilmartin Group, LLC.
Laurence@gilmartinir.com

FAQ

What is the purpose of the Phase 2 study involving IMGO?

The Phase 2 study aims to assess the safety and efficacy of bomedemstat when used in combination with ruxolitinib for treating myelofibrosis (MF).

How many participants will be enrolled in the IMGO Phase 2 study?

The study will enroll approximately 20 participants diagnosed with myelofibrosis.

What are the key findings from ongoing studies of IMGO's bomedemstat?

Ongoing studies show that bomedemstat has been well-tolerated and has led to significant symptom improvement in patients with myelofibrosis and essential thrombocythemia.

What does the combination of bomedemstat and ruxolitinib aim to achieve?

The combination aims to provide a treatment option for patients who have not benefited adequately from ruxolitinib alone.

What is the significance of the trial being investigator-sponsored for IMGO?

An investigator-sponsored trial can facilitate broader research initiatives, potentially leading to new insights into treatment efficacy and safety for IMGO's products.