Targeting mid-2016 for NDA filing for SYM-1219 for the treatment of bacterial vaginosis
NEWARK, NJ, USA I September 21, 2015 I Symbiomix Therapeutics presented data this past Friday, September 18, at the 2015 joint Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC)/International Congress of Chemotherapy (ICC) in San Diego, CA describing the pharmacokinetics of lead product SYM-1219 administered orally with and without a high-fat meal. The data showed bioequivalence between the two conditions, meaning that SYM-1219 can be administered without regards to the timing of food consumption.
SYM-1219 is a single dose, oral antibiotic candidate being studied for the treatment of bacterial vaginosis (BV), a condition characterized by high recurrence and poor adherence to therapy. Symbiomix is targeting a New Drug Application (NDA) filing for SYM-1219 with the U.S. Food and Drug Administration (FDA) in mid-2016. The company recently announced completion of enrollment in a Phase 3 clinical study, which is the second pivotal trial for SYM-1219.
“The favorable pharmacokinetics of SYM-1219 enable single dose, oral administration for the treatment of BV, an important advance in therapy for this serious infection,” said Symbiomix Chief Scientific Officer Helen Pentikis, Ph.D. “The ability to administer the product without regards to the timing of a meal is likely to further increase patient adherence to therapy, a significant unmet need.”
The data were reported via a poster presentation (ICAAC poster board A-017) entitled, “A Phase 1 Study to Determine the Effect of Food on the Pharmacokinetics of a Single Dose of SYM-1219 (SECNIDAZOLE) in Healthy Female Volunteers.” In the study, the bioavailability of secnidazole from SYM-1219 was evaluated following administration in the fasted state and with a standard high-fat meal (50 percent of calories from fat). The results demonstrate that the exposure to secnidazole from SYM-1219 is not affected by a meal. SYM-1219 was well tolerated by all study subjects.
About SYM-1219
SYM-1219 is a novel drug candidate containing secnidazole, which is a next-generation, 5-nitroimidazole antibiotic with favorable pharmacokinetics that facilitate administration as a single-dose oral therapy. Symbiomix is executing a rapid clinical development program with the goal of bringing the drug to the U.S. market for several serious women’s health infections, including BV.
Because of its single-dose oral regimen, Symbiomix believes SYM-1219 will achieve better adherence to treatment than the current standard of care, leading to better health outcomes. Adherence with the current leading therapy for the treatment of BV has been shown to be only approximately 50 percent [1]. Further, poor adherence to anti-infective therapy is a problem that increases with the length and complexity of the drug regimen, and can lead to treatment failures, recurrent disease and the more rapid development of resistant microorganisms [2]. These, in turn, may lead to higher health care costs, including increased out-of-pocket expenses, increased office visits and tests, additional treatment costs, and lost productivity [3].
SYM-1219 has been designated a Qualified Infectious Disease Product (QIDP) by the U.S. Food and Drug Administration (FDA) for the treatment of BV. QIDP designation was created by the GAIN Act in 2012 to create incentives for the development of new drugs intended to treat serious or life threatening infections. QIDP designation makes SYM-1219 eligible for certain benefits, including priority review. Further, if ultimately approved by the FDA, SYM-1219 would be eligible for a five-year extension of exclusivity as an addition to NCE market exclusivity. Last month Symbiomix announced that the FDA also has granted Fast Track designation to SYM-1219 for the treatment of BV.
About Bacterial Vaginosis (BV)
BV is a highly prevalent gynecological infection that increases the risk of serious health problems such as HIV transmission and pre-term birth [4], and is marked by high recurrence rates and low adherence to the current recommended treatments. The disease is characterized by a disruption of the healthy microbiome of the vagina and an overgrowth of anaerobic Gram-negative bacteria. BV affects more than 20 million U.S. women annually and is the most common gynecological infection in the U.S. among women ages 15 to 44 [4,5].
The U.S. Centers for Disease Control and Prevention (CDC) has stated that BV can cause serious health risks, including the following:
- Increasing the risk of HIV transmission from an HIV infected partner;
- Increasing the risk of HIV transmission to an HIV-uninfected partner;
- In pregnant women, increasing the risk of delivering a baby too early; and,
- Increasing the risk of contracting sexually transmitted diseases, such as chlamydia and gonorrhea, which, if untreated, may lead to pelvic inflammatory disease and infertility [4].
BV disproportionately affects disadvantaged populations, including women of color, and may contribute to persistent disparities in women’s health outcomes [4,6,7].
Adherence with the current leading therapy for the treatment of BV has been shown to be only approximately 50 percent [1]. Currently, approximately 50 percent of women treated for BV will experience a recurrence within 12 months.
About Symbiomix Therapeutics, LLC
Symbiomix (sim-bye-OH-mix) is a late-stage, privately held biopharmaceutical company developing innovative medicines for serious women’s health infections that have been long neglected and are in need of new therapeutic options. Symbiomix was founded in 2012 by a team of experienced industry professionals and entrepreneurs and is backed by three of the world’s leading healthcare venture capital firms: OrbiMed, Fidelity Biosciences and HBM Partners. The Company’s lead drug candidate is SYM-1219, a novel product containing secnidazole, which is a next-generation 5-nitroimidazole antibiotic. Symbiomix is based in New Jersey, with additional offices in Maryland and Connecticut. Please visit www.symbiomix.com and follow the Company on LinkedIn and Twitter for more information.
REFERENCES
- Bartley, J.B., et al. (2004). “Personal digital assistants used to document compliance of bacterial vaginosis treatment.” Sex Transm Dis 31(8): 488-491.
- Kardas, P. (2002). “Once-Daily Dosage Secures Better Compliance With Antibiotic Therapy of Respiratory Tract Infections Than Twice-Daily Dosage.” WONCA Europe 2002 Conference, London.
- Kardas, P., Bishai, W., (2006). “Compliance in anti-infective medicine.” Adv Stud Med 2006; 6(7C):S652:S658.
- http://www.cdc.gov/std/bv/stdfact-bacterial-vaginosis.htm
- Allsworth J.E., Peipert, J.F. Prevalence of bacterial vaginosis: 2001-2004 National Health and Nutrition Examination Survey data. Obstetrics and gynecology 2007;109:114-20.
- http://www.cdc.gov/std/bv/stats.htm
- Fiscella, K. (1996). “Racial disparities in preterm births. The role of urogenital infections.” Public Health Rep 111(2): 104-113.
SOURCE: Symbiomix Therapeutics
Post Views: 25
Targeting mid-2016 for NDA filing for SYM-1219 for the treatment of bacterial vaginosis
NEWARK, NJ, USA I September 21, 2015 I Symbiomix Therapeutics presented data this past Friday, September 18, at the 2015 joint Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC)/International Congress of Chemotherapy (ICC) in San Diego, CA describing the pharmacokinetics of lead product SYM-1219 administered orally with and without a high-fat meal. The data showed bioequivalence between the two conditions, meaning that SYM-1219 can be administered without regards to the timing of food consumption.
SYM-1219 is a single dose, oral antibiotic candidate being studied for the treatment of bacterial vaginosis (BV), a condition characterized by high recurrence and poor adherence to therapy. Symbiomix is targeting a New Drug Application (NDA) filing for SYM-1219 with the U.S. Food and Drug Administration (FDA) in mid-2016. The company recently announced completion of enrollment in a Phase 3 clinical study, which is the second pivotal trial for SYM-1219.
“The favorable pharmacokinetics of SYM-1219 enable single dose, oral administration for the treatment of BV, an important advance in therapy for this serious infection,” said Symbiomix Chief Scientific Officer Helen Pentikis, Ph.D. “The ability to administer the product without regards to the timing of a meal is likely to further increase patient adherence to therapy, a significant unmet need.”
The data were reported via a poster presentation (ICAAC poster board A-017) entitled, “A Phase 1 Study to Determine the Effect of Food on the Pharmacokinetics of a Single Dose of SYM-1219 (SECNIDAZOLE) in Healthy Female Volunteers.” In the study, the bioavailability of secnidazole from SYM-1219 was evaluated following administration in the fasted state and with a standard high-fat meal (50 percent of calories from fat). The results demonstrate that the exposure to secnidazole from SYM-1219 is not affected by a meal. SYM-1219 was well tolerated by all study subjects.
About SYM-1219
SYM-1219 is a novel drug candidate containing secnidazole, which is a next-generation, 5-nitroimidazole antibiotic with favorable pharmacokinetics that facilitate administration as a single-dose oral therapy. Symbiomix is executing a rapid clinical development program with the goal of bringing the drug to the U.S. market for several serious women’s health infections, including BV.
Because of its single-dose oral regimen, Symbiomix believes SYM-1219 will achieve better adherence to treatment than the current standard of care, leading to better health outcomes. Adherence with the current leading therapy for the treatment of BV has been shown to be only approximately 50 percent [1]. Further, poor adherence to anti-infective therapy is a problem that increases with the length and complexity of the drug regimen, and can lead to treatment failures, recurrent disease and the more rapid development of resistant microorganisms [2]. These, in turn, may lead to higher health care costs, including increased out-of-pocket expenses, increased office visits and tests, additional treatment costs, and lost productivity [3].
SYM-1219 has been designated a Qualified Infectious Disease Product (QIDP) by the U.S. Food and Drug Administration (FDA) for the treatment of BV. QIDP designation was created by the GAIN Act in 2012 to create incentives for the development of new drugs intended to treat serious or life threatening infections. QIDP designation makes SYM-1219 eligible for certain benefits, including priority review. Further, if ultimately approved by the FDA, SYM-1219 would be eligible for a five-year extension of exclusivity as an addition to NCE market exclusivity. Last month Symbiomix announced that the FDA also has granted Fast Track designation to SYM-1219 for the treatment of BV.
About Bacterial Vaginosis (BV)
BV is a highly prevalent gynecological infection that increases the risk of serious health problems such as HIV transmission and pre-term birth [4], and is marked by high recurrence rates and low adherence to the current recommended treatments. The disease is characterized by a disruption of the healthy microbiome of the vagina and an overgrowth of anaerobic Gram-negative bacteria. BV affects more than 20 million U.S. women annually and is the most common gynecological infection in the U.S. among women ages 15 to 44 [4,5].
The U.S. Centers for Disease Control and Prevention (CDC) has stated that BV can cause serious health risks, including the following:
- Increasing the risk of HIV transmission from an HIV infected partner;
- Increasing the risk of HIV transmission to an HIV-uninfected partner;
- In pregnant women, increasing the risk of delivering a baby too early; and,
- Increasing the risk of contracting sexually transmitted diseases, such as chlamydia and gonorrhea, which, if untreated, may lead to pelvic inflammatory disease and infertility [4].
BV disproportionately affects disadvantaged populations, including women of color, and may contribute to persistent disparities in women’s health outcomes [4,6,7].
Adherence with the current leading therapy for the treatment of BV has been shown to be only approximately 50 percent [1]. Currently, approximately 50 percent of women treated for BV will experience a recurrence within 12 months.
About Symbiomix Therapeutics, LLC
Symbiomix (sim-bye-OH-mix) is a late-stage, privately held biopharmaceutical company developing innovative medicines for serious women’s health infections that have been long neglected and are in need of new therapeutic options. Symbiomix was founded in 2012 by a team of experienced industry professionals and entrepreneurs and is backed by three of the world’s leading healthcare venture capital firms: OrbiMed, Fidelity Biosciences and HBM Partners. The Company’s lead drug candidate is SYM-1219, a novel product containing secnidazole, which is a next-generation 5-nitroimidazole antibiotic. Symbiomix is based in New Jersey, with additional offices in Maryland and Connecticut. Please visit www.symbiomix.com and follow the Company on LinkedIn and Twitter for more information.
REFERENCES
- Bartley, J.B., et al. (2004). “Personal digital assistants used to document compliance of bacterial vaginosis treatment.” Sex Transm Dis 31(8): 488-491.
- Kardas, P. (2002). “Once-Daily Dosage Secures Better Compliance With Antibiotic Therapy of Respiratory Tract Infections Than Twice-Daily Dosage.” WONCA Europe 2002 Conference, London.
- Kardas, P., Bishai, W., (2006). “Compliance in anti-infective medicine.” Adv Stud Med 2006; 6(7C):S652:S658.
- http://www.cdc.gov/std/bv/stdfact-bacterial-vaginosis.htm
- Allsworth J.E., Peipert, J.F. Prevalence of bacterial vaginosis: 2001-2004 National Health and Nutrition Examination Survey data. Obstetrics and gynecology 2007;109:114-20.
- http://www.cdc.gov/std/bv/stats.htm
- Fiscella, K. (1996). “Racial disparities in preterm births. The role of urogenital infections.” Public Health Rep 111(2): 104-113.
SOURCE: Symbiomix Therapeutics
Post Views: 25
