Affymax and Takeda Report Phase 2 Analyses of Hematide/peginesatide in Hemodialysis Patients

Update: Omontys (peginesatide) Now FDA Approved - March 27, 2012

-- Results from Post Hoc Analyses Presented at National Kidney Foundation 2010 Spring Meeting --


 

ORLANDO, Fla.--(BUSINESS WIRE)--Apr 15, 2010 - Affymax, Inc. (Nasdaq: AFFY) and Takeda Global Research & Development Center, Inc., U.S., today announced data from several post hoc analyses of Phase 2 clinical trials that evaluated Hematide/peginesatide in dialysis patients with anemia in chronic kidney disease (CKD). The data provide hypotheses for further investigation of this agent in anemia management in this patient population. The findings were presented in three separate posters at the National Kidney Foundation (NKF) Annual Meeting being held in Orlando, Florida.


 

According to the U.S.-approved labels for erythropoiesis stimulating agents (ESAs), it is recommended that hemoglobin (Hb) levels be maintained within ranges of 10-12 grams per deciliter (g/dL) in patients with renal disease or chronic renal failure (CRF).1,2,3 However, there may be difficulties achieving this goal, including Hb fluctuations below or above recommended ranges (Hb variability or cycling), the need for frequent dose adjustments or elevated doses to keep poor ESA responders within range, and other potential concerns.4,5 Another treatment challenge is maintaining Hb levels in dialysis patients who have been hospitalized.6


 

“The reality of managing anemia with ESAs in CRF patients presents certain challenges,” said Anne-Marie Duliege, M.D., chief medical officer at Affymax. “Randomized, controlled, comparative Phase 3 studies of Hematide are ongoing, which will provide additional information in this population.”


 

“These Phase 2 analyses reinforce the importance of evaluating issues that affect this fragile patient population,” said Ali Hariri, M.D., medical director, Takeda. “Our goal with Hematide is to provide physicians with a convenient alternative treatment option to help manage anemia in people with chronic renal failure.”


 

Analysis of Hemoglobin Stability with Hematide/peginesatide in Hemodialysis Patients (Poster #217) – 14, April 2010


 

Based on data from 62 dialysis patients enrolled in one of the open-label Phase 2 extension studies, Hematide, administered once every four weeks, appeared to keep patients within Hb target ranges, with relatively stable mean Hb levels maintained over time. Based on Hb levels over a six month period, Hb cycling, as defined by two consecutive Hb excursions (a change in monthly Hb level ‰¥ 1.5 g/dL) in different directions, was observed in 8.6 percent of patients treated with Hematide.


 

Epoetin Alfa and Hematide/peginesatide Requirements Differ in Erythropoiesis-Stimulating Agent Hyporesponsive Hemodialysis Patients (Poster #63) – 14, April 2010


 

A post hoc analysis of the data from 145 dialysis patients enrolled in two open-label Phase 2 studies examined the response to Hematide treatment in patients directly switched from epoetin alfa given three times a week. Hematide doses were titrated over a five-to-six month period to maintain target Hb concentrations. Patients who received ‰¥ six doses of Hematide (n=145) were divided into three groups based on their baseline dose of epoetin alfa: highest (top 10 percent; relatively hyporesponsive), lowest (bottom 10 percent; relatively sensitive) and middle (80 percent). The results suggest that patients requiring more epoetin alfa appear to require lower doses of Hematide. The dose ratio for the top 10 percent of patients compared to the bottom 10 percent of patients was 5.6 for epoetin alfa and 2.2 for Hematide.


 

Evaluation of the Maintenance of Hemoglobin Control in Hemodialysis Patients Both During and After Hospitalization with Once-Monthly Hematide/peginesatide (Poster #163) – 14, April 2010


 

Another post hoc analysis in 47 dialysis patients from the two open-label Phase 2 extension studies, treated with Hematide once every four weeks, was performed to evaluate the changes in Hb levels pre- to post-hospitalization, as well as the amount of time and Hematide dose to recover to pre-hospitalization Hb levels. The average (mean) Hb levels for Hematide patients were 11.1 g/dL before hospitalization and 10.8 g/dL immediately post-hospitalization. Hb values at one and two months following hospitalization were 10.9 g/dL and 11.2 g/dL respectively. In addition, the mean change in pre- to post-hospitalization dose requirements was minimal (5-10%) during the two months post-hospitalization and back to baseline thereafter.


 

Across the studies that were the basis of these three posters, serious adverse events that were considered possibly related to Hematide treatment by study investigators included an infusion-site reaction and a patient who developed a fatal pulmonary embolism. The most common adverse events included upper respiratory tract infection, arteriovenous fistula site complication, dyspnea, diarrhea, muscle spasms, headache, nausea and vomiting. None of the patients developed Hematide-specific antibodies.


 

In addition, three other posters entitled “Long-Term Clinical Experience with Hematide/peginesatide” (poster #161), “Hemoglobin Decline Following Hematide/peginesatide Dose Interruption (poster #43)” and “Hematide/peginesatide Dose Adjustments in the Maintenance of Hemoglobin in Hemodialysis Patients (poster #240)” were presented at the meeting.


 

The clinical significance of all these post hoc analyses are unknown and warrant further investigation. Phase 3 studies are ongoing.


 

About Hematide


 

Hematide is a novel synthetic, PEGylated peptidic compound that binds to and activates the erythropoietin receptor and thus acts as an ESA. Peginesatide is the USAN or nonproprietary name for the compound. Affymax and Takeda are collaborating on the development of Hematide and plan to co-commercialize the product if approved in the United States. Phase 3 clinical trials were designed to investigate the potential for Hematide to treat anemia associated with chronic renal failure. The product, upon approval, will be commercialized outside the United States (in the European Union and Japan) by Takeda.


 

About Anemia in Chronic Renal Failure (CRF)


 

Anemia in CRF affects many individuals with Chronic Kidney Disease (CKD).7 According to the National Kidney Foundation, 26 million Americans - 1 in 9 U.S. adults - have CKD.8,9 Anemia develops in the early stages of CKD and worsens as patients progress towards total kidney failure and need a dialysis machine to eliminate waste and water from their blood.7 In severe or prolonged cases of anemia, the lack of oxygen in the blood can cause serious and sometimes fatal damage to the heart and other organs.10


 

About Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc.


 

Based in Deerfield, Ill., Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc. are subsidiaries of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. The respective companies currently market oral diabetes, insomnia, rheumatology and gastroenterology treatments and seek to bring innovative products to patients through a pipeline that includes compounds in development for diabetes, cardiovascular disease, gastroenterology, neurology and other conditions. To learn more about these Takeda companies, visit www.tpna.com.


 

About Affymax, Inc.


 

Affymax, Inc. is a biopharmaceutical company committed to developing novel drugs to improve the treatment of serious and often life-threatening conditions. For additional information, please visit www.affymax.com.


 

This release contains forward-looking statements, including statements regarding the success of the collaboration, timing, design and results of the Company's clinical trials and drug development program and the timing and likelihood of the commercialization of Hematide. The Company's actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties, including risks relating to the continued safety and efficacy of Hematide in clinical development, the potential for once per month dosing and room temperature stability, the cardiovascular event rate in our Phase 3 program, the timing of patient accrual in ongoing and planned clinical studies, regulatory requirements and approvals, research and development efforts, industry and competitive environment, intellectual property rights and disputes and other matters that are described in Affymax's annual report on Form 10-K filed with the Securities and Exchange Commission. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. The Company undertakes no obligation to update any forward-looking statement in this press release.


 

1 Aranesp [package insert]. Thousand Oaks, Calif.: Amgen Inc.; 2010.

2 Epogen [package insert]. Thousand Oaks, Calif.: Amgen Inc.; 2010.

3 Procrit [package insert]. Raritan, NJ: Centocor Ortho Biotech Products LP; 2010.

4 Fishbane et al. “Hemoglobin Cycling in Hemodialysis Patients Treated With Recombinant Human Erythropoietin.” Kidney International 2005; Vol. 68 (2005), pp. 1337–1343

5 Kotanko et al. “Epoetin Alfa and Hematide/peginesatide Requirements Differ in Erythropoiesis-Stimulating Agent Hyporesponsive Patients.” Submitted to the National Kidney Foundation Spring Clinical Meetings, April 2010

6 Zabaneh et al. “Evaluation of the Maintenance of Hemoglobin Control in Hemodialysis Patients Both During and After Hospitalization with Once-Monthly Hematide/peginesatide.” Submitted to the National Kidney Foundation Spring Clinical Meetings, April 2010

7 National Institute of Diabetes and Digestive and Kidney Diseases.

http://kidney.niddk.nih.gov/kudiseases/pubs/anemia. Accessed March 17, 2010

8 National Kidney Foundation. http://www.kidney.org/kidneydisease/ckd/index.cfm. Accessed March 17, 2010

9 National Kidney Foundation. “Anemia and Chronic Kidney Disease.” http://www.kidney.org/Atoz/pdf/anemia.pdf. Accessed March 17, 2010

10 National Heart Lung Blood Institute. http://www.nhlbi.nih.gov/health/dci/Diseases/anemia/anemia_whatis.html. Accessed on March 17, 2010


 

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Contact: Corporate:

Affymax, Inc.

Sylvia Wheeler, 650-812-8861

Vice President, Corporate Communications

or

Takeda Global Research & Development Center, Inc., U.S.

Julia Ellwanger, 224-554-7681

Corporate Communications


 

 

Posted: April 2010

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