Imago BioSciences Presents Positive Data from Ongoing Phase 2 Study of Bomedemstat in Advanced Myelofibrosis at ASH 2022

Rhea-AI Summary

Imago BioSciences (Nasdaq: IMGO) announced promising results from its Phase 2 trial of bomedemstat for advanced myelofibrosis (MF). As of October 18, 2022, 66% of patients exhibited spleen volume reduction, and 65% showed improved symptom scores after 24 weeks. Remarkably, no patients progressed to acute myeloid leukemia during treatment. The trial is fully enrolled, and an additional study combining bomedemstat with ruxolitinib is in progress. The treatment is reported to be generally safe and well-tolerated, with no new mutations noted.

Positive

• 66% of patients showed spleen volume reduction.
• 65% of patients had improved total symptom scores.
• No progression to acute myeloid leukemia observed.
• The Phase 2 study is fully enrolled.
• Bomedemstat demonstrated general safety and tolerability.

Negative

• None.

- As of the data cutoff of 18 October 2022, bomedemstat demonstrated spleen volume reduction in 66% (33/50) of patients and reduction in total symptom score in 65% (17/26) of patients at 24 weeks -

- No patients in this Phase 2 study of bomedemstat in advanced myelofibrosis have progressed to acute myeloid leukemia while on treatment -

- The Phase 2 study of bomedemstat in advanced myelofibrosis is fully enrolled, with an investigator-sponsored Phase 2 combination study of bomedemstat and ruxolitinib in myelofibrosis currently screening patients -

REDWOOD CITY, Calif., Dec. 12, 2022 (GLOBE NEWSWIRE) -- Imago BioSciences, Inc. (“Imago”) (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 presented positive data from its ongoing global Phase 2 clinical study evaluating bomedemstat in patients with advanced myelofibrosis (MF).

The data were presented in a poster presentation session during the 64^th American Society of Hematology Annual Meeting and Exposition (ASH) taking place 10-13 December 2022. A Phase 2 data set with a cut-off date of 29 April 2022 was previously presented at the 30^th European Hematology Association Annual Meeting and congress (EHA) in June 2022.

Updated Highlights (available data as of 18 October 2022)

• Of evaluable patients at 24 weeks:
  • 65% (17/26) showed a decrease in Total Symptom Score (TSS).
  • 19% (5/26) showed a ≥ 50% decrease in TSS.
  • 66% (33/50) showed spleen volume reductions from baseline.
  • 28% (14/50) showed a ≥ 20% spleen volume reduction.
• The majority of patients had a decrease in mutant allele frequencies (MAF) including driver mutations (e.g., JAK2) and high molecular risk (HMR) mutations (e.g., ASXL1).
• 90% (37/41) of transfusion-independent patients had stable (19/41) or improved (18/41) hemoglobin at Week 12.
• 85% (50/59) of patients had an improved (19/59) or stable (31/59) bone marrow fibrosis score post-baseline.
• No new mutations or transformations to acute myeloid leukemia (AML) while on treatment, even in patients with a high-risk of progression.
  

“Bomedemstat continues to demonstrate its potential as a monotherapy for patients suffering from advanced myelofibrosis, highlighted by the data presented at ASH showing improvements in patient symptom scores, spleen volumes, fibrosis, and anemia,” said Hugh Young Rienhoff, Jr., M.D., Chief Executive Officer of Imago BioSciences. “I am also delighted we continue to see the majority of patients experience a decrease in mutant allele frequencies and no progression to AML, even in patients with ASXL1 mutations known to confer a high-risk of transformation. We are further exploring the use of bomedemstat in myelofibrosis in an investigator-sponsored Phase 2 combination study with ruxolitinib; patients are currently being screened.”

Safety and Tolerability

• Bomedemstat was generally safe and well-tolerated in patients with myelofibrosis.
• The most common non-hematologic adverse event (AE) related to bomedemstat was dysgeusia (altered taste), which occurred in 33% (30/90) of patients and led to discontinuation of the study in 1 patient.
• There were 44 patients who reported a total of 86 serious adverse events (SAEs), 16% of which were deemed drug-related by the investigator.
  

Details on the Imago ASH Poster Presentation

Poster Presentation Title: “A Phase 2 Study of the LSD1 Inhibitor Bomedemstat (IMG-7289) for the Treatment of Advanced Myelofibrosis (MF): Updated Results and Genomic Analyses”
Session Name: Myeloproliferative Syndromes: Clinical and Epidemiological: Poster III
Presentation Date/Time: Monday, December 12, 2022, at 7:00 PM ET
Location: Ernest N. Morial Convention Center, Hall D
Presenting Author: Kristen Pettit, University of Michigan

For further details, please see the ASH 2022 abstract and presentation on the Imago website here.

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. Imago 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 were the results of the IMGO Phase 2 study for bomedemstat?

The Phase 2 study of bomedemstat showed that 66% of patients had spleen volume reduction and 65% experienced an improvement in symptom scores.

What is the status of the Phase 2 trial for bomedemstat as of October 2022?

As of October 2022, the Phase 2 trial of bomedemstat is fully enrolled, and an additional combination study with ruxolitinib is currently screening patients.

Are there any safety concerns regarding the treatment with bomedemstat?

Bomedemstat has been reported as generally safe and well-tolerated, with no new mutations or transformations to acute myeloid leukemia during the treatment.

What is the significance of the results from the recent ASH presentation for IMGO?

The ASH presentation highlighted the potential of bomedemstat as a monotherapy for advanced myelofibrosis, showcasing significant reductions in spleen volume and symptom improvements.