Trends toward efficacy observed in exploratory objectives
LEXINGTON, MA, USA I May 2, 2014 I Avaxia Biologics, Inc., a clinical-stage biopharmaceutical company developing gut-targeted therapeutics, announced today that primary and secondary objectives were successfully met in a first-in-human Phase 1b clinical trial of AVX-470, an oral anti-TNF bovine polyclonal antibody, in patients with active ulcerative colitis.
The primary objective of the trial was to evaluate the safety and tolerability of AVX-470. No treatment-related serious adverse events (SAEs) were observed, and there were no allergic reactions or opportunistic infections.
The secondary objectives of the trial were to evaluate the pharmacokinetics and immunogenicity of AVX-470. Pharmacokinetics were assessed by measuring bovine immunoglobulin levels in serum, stool and colon tissues. Immunogenicity was assessed by measuring whether AVX-470 induced a human anti-bovine immunoglobulin antibody (HABA) response in serum. Serum concentrations of bovine immunoglobulin remained within the range of baseline values established in patients before dosing with AVX-470, supporting the hypothesis that AVX-470 acts locally in the gut. As expected, many patients had low concentrations of bovine immunoglobulin in serum at baseline, presumably from dietary exposure. Bovine immunoglobulin was detected in colon tissue, confirming that the antibody can penetrate into the colon tissue in ulcerative colitis patients. Bovine immunoglobulin was also detected in stool and had the ability to bind TNF, confirming that AVX-470 resists digestion in the gut. Finally, treatment with AVX-470 did not cause an increase in HABA in serum, supporting the hypothesis that the antibody will display minimal immunogenicity.
The trial also included as exploratory objectives the evaluation of clinical and endoscopic responses and effects on biomarkers. AVX-470 showed consistent trends across multiple clinically important endpoints and reduced serum C reactive protein (CRP) and tissue TNF levels at the highest dose. These efficacy trends are highly encouraging because they were reached with a small number of patients after only four weeks of dosing, as compared to the eight weeks of dosing typically required to see significant effects with ulcerative colitis treatments.
“Results from our first clinical trial with AVX-470 exceeded our expectations. AVX-470 was well tolerated with no safety signals observed, exhibited the pharmacokinetic properties needed for a gut-targeted antibody therapeutic, and did not induce an anti-drug antibody response. In addition, AVX-470 showed consistent efficacy trends for clinical response, clinical remission, and both pharmacodynamic and disease-associated biomarkers,” said Barbara S. Fox, Chief Executive Officer of Avaxia. “With such positive results, we plan to advance AVX-470 into Phase 2 development.”
The Phase 1b trial was a double-blind, placebo-controlled, ascending dose study of AVX-470 in active ulcerative colitis patients. This was the first human study of AVX-470. Three different dose levels of AVX-470 were administered for a period of 28 days. The study involved 14 trial centers in the U.S., Canada, Belgium and Hungary. A total of 36 patients were treated in the trial, with nine patients receiving placebo and 27 patients receiving the drug. The trial was completed in December 2013.
Avaxia plans to disclose detailed study results at upcoming scientific meetings or in a peer-reviewed publication.
About Inflammatory Bowel Disease
Inflammatory bowel disease (IBD) is a serious disease affecting more than 2.5 million people. IBD refers to two related but different diseases: ulcerative colitis and Crohn’s disease. These diseases cause chronic inflammation of the intestinal tract, resulting in a significant reduction in quality of life and the risk of life-threatening complications and diseases, including cancer. As a chronic autoimmune disease, IBD is characterized by periods of active disease that alternate with periods of disease control (remission). The annual worldwide market for IBD medications exceeds $4.5 billion, approximately $2.5 billion of which represents sales of currently marketed anti-TNF antibodies.
About AVX-470
AVX-470 is the first gut-targeted anti-TNF antibody in clinical development. The lead indication is inflammatory bowel disease (IBD). Currently marketed anti-TNF drugs are highly effective for the treatment of IBD. However, despite their success, these drugs have two significant drawbacks. One is that they must be injected, whereas patients prefer oral medications. More importantly, they cause rare but serious side effects, such as risk of serious infection, because they dampen the immune system throughout the body, not just in the intestines where the disease occurs. As a result, these drugs are used mostly as a second- or third-line therapy, despite evidence that earlier use may improve patient outcomes. In contrast, AVX-470 is an orally administered antibody therapeutic that targets the gut, potentially improving safety and efficacy over existing anti-TNF therapies. Avaxia believes that AVX-470 has the potential to become a first-line therapy that transforms the treatment of IBD.
About Avaxia Biologics
Avaxia is a leader in the growing field of gut-targeted therapeutics — orally administered, minimally absorbed drugs that are designed to act locally in the gastrointestinal tract. Avaxia’s lead clinical candidate, AVX-470, is an oral anti-TNF antibody for inflammatory bowel disease. AVX-470 offers potentially improved safety and efficacy over existing anti-TNF therapies by focusing immune suppression only where needed in the diseased gut. Avaxia plans to use its gut-targeted antibody platform to develop therapeutics to address many other serious diseases such as celiac disease, metabolic disease and GI acute radiation syndrome. www.avaxiabiologics.com.
SOURCE: Avaxia Biologics
Post Views: 126
Trends toward efficacy observed in exploratory objectives
LEXINGTON, MA, USA I May 2, 2014 I Avaxia Biologics, Inc., a clinical-stage biopharmaceutical company developing gut-targeted therapeutics, announced today that primary and secondary objectives were successfully met in a first-in-human Phase 1b clinical trial of AVX-470, an oral anti-TNF bovine polyclonal antibody, in patients with active ulcerative colitis.
The primary objective of the trial was to evaluate the safety and tolerability of AVX-470. No treatment-related serious adverse events (SAEs) were observed, and there were no allergic reactions or opportunistic infections.
The secondary objectives of the trial were to evaluate the pharmacokinetics and immunogenicity of AVX-470. Pharmacokinetics were assessed by measuring bovine immunoglobulin levels in serum, stool and colon tissues. Immunogenicity was assessed by measuring whether AVX-470 induced a human anti-bovine immunoglobulin antibody (HABA) response in serum. Serum concentrations of bovine immunoglobulin remained within the range of baseline values established in patients before dosing with AVX-470, supporting the hypothesis that AVX-470 acts locally in the gut. As expected, many patients had low concentrations of bovine immunoglobulin in serum at baseline, presumably from dietary exposure. Bovine immunoglobulin was detected in colon tissue, confirming that the antibody can penetrate into the colon tissue in ulcerative colitis patients. Bovine immunoglobulin was also detected in stool and had the ability to bind TNF, confirming that AVX-470 resists digestion in the gut. Finally, treatment with AVX-470 did not cause an increase in HABA in serum, supporting the hypothesis that the antibody will display minimal immunogenicity.
The trial also included as exploratory objectives the evaluation of clinical and endoscopic responses and effects on biomarkers. AVX-470 showed consistent trends across multiple clinically important endpoints and reduced serum C reactive protein (CRP) and tissue TNF levels at the highest dose. These efficacy trends are highly encouraging because they were reached with a small number of patients after only four weeks of dosing, as compared to the eight weeks of dosing typically required to see significant effects with ulcerative colitis treatments.
“Results from our first clinical trial with AVX-470 exceeded our expectations. AVX-470 was well tolerated with no safety signals observed, exhibited the pharmacokinetic properties needed for a gut-targeted antibody therapeutic, and did not induce an anti-drug antibody response. In addition, AVX-470 showed consistent efficacy trends for clinical response, clinical remission, and both pharmacodynamic and disease-associated biomarkers,” said Barbara S. Fox, Chief Executive Officer of Avaxia. “With such positive results, we plan to advance AVX-470 into Phase 2 development.”
The Phase 1b trial was a double-blind, placebo-controlled, ascending dose study of AVX-470 in active ulcerative colitis patients. This was the first human study of AVX-470. Three different dose levels of AVX-470 were administered for a period of 28 days. The study involved 14 trial centers in the U.S., Canada, Belgium and Hungary. A total of 36 patients were treated in the trial, with nine patients receiving placebo and 27 patients receiving the drug. The trial was completed in December 2013.
Avaxia plans to disclose detailed study results at upcoming scientific meetings or in a peer-reviewed publication.
About Inflammatory Bowel Disease
Inflammatory bowel disease (IBD) is a serious disease affecting more than 2.5 million people. IBD refers to two related but different diseases: ulcerative colitis and Crohn’s disease. These diseases cause chronic inflammation of the intestinal tract, resulting in a significant reduction in quality of life and the risk of life-threatening complications and diseases, including cancer. As a chronic autoimmune disease, IBD is characterized by periods of active disease that alternate with periods of disease control (remission). The annual worldwide market for IBD medications exceeds $4.5 billion, approximately $2.5 billion of which represents sales of currently marketed anti-TNF antibodies.
About AVX-470
AVX-470 is the first gut-targeted anti-TNF antibody in clinical development. The lead indication is inflammatory bowel disease (IBD). Currently marketed anti-TNF drugs are highly effective for the treatment of IBD. However, despite their success, these drugs have two significant drawbacks. One is that they must be injected, whereas patients prefer oral medications. More importantly, they cause rare but serious side effects, such as risk of serious infection, because they dampen the immune system throughout the body, not just in the intestines where the disease occurs. As a result, these drugs are used mostly as a second- or third-line therapy, despite evidence that earlier use may improve patient outcomes. In contrast, AVX-470 is an orally administered antibody therapeutic that targets the gut, potentially improving safety and efficacy over existing anti-TNF therapies. Avaxia believes that AVX-470 has the potential to become a first-line therapy that transforms the treatment of IBD.
About Avaxia Biologics
Avaxia is a leader in the growing field of gut-targeted therapeutics — orally administered, minimally absorbed drugs that are designed to act locally in the gastrointestinal tract. Avaxia’s lead clinical candidate, AVX-470, is an oral anti-TNF antibody for inflammatory bowel disease. AVX-470 offers potentially improved safety and efficacy over existing anti-TNF therapies by focusing immune suppression only where needed in the diseased gut. Avaxia plans to use its gut-targeted antibody platform to develop therapeutics to address many other serious diseases such as celiac disease, metabolic disease and GI acute radiation syndrome. www.avaxiabiologics.com.
SOURCE: Avaxia Biologics
Post Views: 126
