Nov 7, 2017 | Appili Therapeutics, News
See original post here
For Immediate Release
November 7, 2017 – HALIFAX, Nova Scotia –– Appili Therapeutics Inc. (the “Company” or “Appili”), an anti-infective drug development company, announced today it has been awarded a $1.2 million USD grant by the Department of Defense, Congressionally Directed Medical Research Programs, Peer Reviewed Medical Research Program .
The Peer Reviewed Medical Research Program (PRMP) supports military health-related research that has the potential to make a strong impact on patient care. Appili will use the funds to develop a lead compound as a preclinical candidate for its ATI-1503 antibiotic program targeting drug-resistant, Gram-negative bacteria.
“Drug-resistant bacteria threaten a doctor’s ability to care for battlefield wounds among military service men and women,” said Kevin Sullivan, CEO of Appili Therapeutics. “We are honoured to have been selected for this PRMRP award, which helps us advance our most promising antibiotic candidate through the critical early stages of development.”
Drug-resistant bacteria constitute some of the highest threats to human health, with over 2 million infections and at least 23,000 deaths each year in the U.S. alone. These superbugs can present serious challenges in both battlefield situations, as well as in veterans’ hospitals, making it a priority research area for the Department of Defense (DOD).
ATI-1503 is a synthetic version of the naturally-occurring antibiotic called Negamycin. Its broad spectrum activity allows it to tackle the most deadly Gram-negative bacteria, including Klebsiella pneumoniae, Acinetobactor baumannii, and Pseudomonas aeruginosa. These are high priority pathogens for the Centers for Disease Control and Prevention and the World Health Organization because of the lack of effective antibiotic treatment options for the most resistant strains.
Appili’s expert drug development team will use the PRMRP funding to optimize the potency of ATI-1503 to effectively target Gram-negative bacteria. Because Gram-negative bacteria have two protective cellular walls, it is hard for existing antibiotics to penetrate. ATI-1503 holds promise for treating these superbugs because it penetrates the double exterior membranes and attacks the protein generating machinery of the Gram-negative bacteria.
About the PRMRP Grant
This work is supported by the DOD Congressionally Directed Medical Research Programs through the Peer Reviewed Medical Research Program under Award No. W81XWH-17-1-0180. In conducting this research, the investigators will adhere to the laws of the United States and regulations of the Department of Agriculture, as well as the CDC-NIH Guide for Biosafety in Microbiological and Biomedical Laboratories. For more information, visit http://cdmrp.army.mil.
About Appili Therapeutics
Appili is dedicated to identifying, acquiring and advancing novel therapeutics for infectious disease. The company has two anti-infective programs, ATI-1501 and ATI-1503, in its pipeline. ATI-1501 is a taste-masked treatment for anaerobic infections, including C. difficile. Appili’s second product, ATI-1503, is a novel antibiotic with broad potential to treat drug-resistant Gram-negative infections. For more information visit www.AppiliTherapeutics.com.
Media Relations Contact:
Jennifer Cameron
T: 902-209-4704
E: [email protected]
Investor Relations Contact:
Kevin Sullivan, CEO, Appili Therapeutics
T: 902-442-4655
E: [email protected]]]>
Nov 2, 2017 | Appili Therapeutics, News
For Immediate Release
HALIFAX, Nova Scotia – October 30, 2017 – Appili Therapeutics Inc. (the “Company” or “Appili”), an anti-infective drug development company, announced today that both the US Food and Drug Administration (FDA) and Health Canada have cleared its IND and CTA clinical investigation applications, respectively, to conduct a clinical trial of ATI-1501, a taste-masked antibiotic targeting anaerobic bacteria like Clostridium difficile. ATI-1501 has been optimized in an oral liquid suspension to provide patients who have difficulty swallowing with a more convenient alternative to the currently marketed metronidazole tablet.
Appili plans to conduct the ATI-1501 clinical study in Toronto, Ontario and will begin recruiting subjects in November 2017. The company expects to enroll approximately 40 healthy volunteers in this bioavailability study.
“Having both Health Canada and FDA authorization affirms our confidence in our regulatory and development strategy,” said Kevin Sullivan CEO of Appili Therapeutics. “We’re excited to take ATI-1501 into clinical trials because it brings us a step closer to offering physicians a new weapon to fight serious infections and improve patient compliance.”
ATI-1501 fulfills an unmet market need for millions of people with swallowing difficulties who have been prescribed metronidazole. These individuals, primarily children and the elderly, are not completing their full course of metronidazole tablets because of the extreme bitter taste and difficulty swallowing tablets. Poor patient compliance is leading to the spread of infection, recurrent infections, and antibiotic resistance, which makes treatment more complicated and expensive. As the mainstay for treating anaerobic bacterial infections, IMS Health reports that over 9.5 million prescriptions of metronidazole tablets are issued in the US each year.
Appili’s ATI-1501 oral liquid antibiotic candidate has been taste-masked to improve palatability and reduce issues with non-compliance. Once ingested, the well-studied and established antibiotic is designed to kill anaerobic bacteria by interfering with their DNA, which clears up the infection.
“We expect the completion of this clinical trial will set us up to file our new drug application in 2018 and advance our commercialization activities,” said Jamie Doran, Vice President of Drug Development of Appili Therapeutics.
Appili’s regulatory strategy involves registration using a 505(b)(2) pathway in the US, which is an abbreviated FDA pathway that allows the Company to reference safety and efficacy data of the original oral metronidazole tablet.
About Appili Therapeutics
Appili is dedicated to identifying, acquiring and advancing novel therapeutics for infectious disease. The Company has two anti-infective programs, ATI-1501 and ATI-1503, in its pipeline. ATI-1501 is a taste-masked treatment for anaerobic infections that has been granted orphan drug status by the FDA. Appili’s second product, ATI-1503, is a novel antibiotic with broad potential to treat deadly Gram-negative infections. These drug-resistant infections have been identified by the US Centers for Disease Control (CDC) and the World Health Organization as posing the highest threat to human health. For more information visit www.AppiliTherapeutics.com.
Media Relations Contact:
Jennifer Cameron
T: 902-209-4704
E: [email protected]
Investor Relations Contact:
Kevin Sullivan, CEO, Appili Therapeutics
T: 902-442-4655
E: [email protected]]]>
Oct 23, 2017 | Appili Therapeutics, News
For Immediate Release
October 23, 2017 – HALIFAX, Nova Scotia –– Appili Therapeutics Inc. (the “Company” or “Appili”), an anti-infective drug development company, announced today it raised $3,062,000 in a private placement financing, bringing the total equity raised since its seed round in March 2016 to $7,477,000.
This private placement includes investments from new and current investors including Innovacorp, Nova Scotia’s early stage venture capital organization. Proceeds from the financing will be used to fund operations and the continued growth of the company. Specifically, the additional funding will enable Appili to advance its pipeline of anti-infectives and move its lead antibiotic, a taste-masked treatment for anaerobic infections, into the clinic.
“Appili has assembled a team with the proven ability to bring new antibiotics to market, and has made remarkable progress in building a pipeline that addresses major unmet needs in bacterial infections,” said Dr. Lidija Marušić, life sciences investment manager at Innovacorp and member of Appili’s Board of Directors. Innovacorp has participated in all of Appili’s financing rounds.
“There is a robust market opportunity for antibiotics that really bring value and the successful closing of this financing round reflects that,” said Kimberly Stephens, CFO of Appili Therapeutics.
“We appreciate the confidence investors have in our strategy to build a balanced-risk pipeline of products designed to treat the most serious and drug-resistant infections affecting patients today,” said Kevin Sullivan, CEO of Appili Therapeutics.
Appili is dedicated to identifying, acquiring and advancing novel therapeutics for infectious disease. The Company has two anti-infective programs, ATI-1501 and ATI-1503, in its pipeline. ATI-1501 is a taste-masked treatment for anaerobic infections that has been granted orphan drug status by the FDA. Appili plans to take ATI-1501 into clinical trials in 2017. Appili’s second product, ATI-1503, is a novel antibiotic with broad potential to treat deadly Gram-negative infections. These drug-resistant infections have been identified by the U.S. Centers for Disease Control (CDC) and the World Health Organization as posing the highest threat to human health.
For more information visit www.AppiliTherapeutics.com.
For more information, please contact:
Jennifer Cameron
902.209.4704
[email protected]
Investor Relations
Kimberly Stephens, CFO
Appili Therapeutics
[email protected]]]>
Jul 26, 2016 | Appili Therapeutics, News
entrevestor.com, written by Peter Moreira
Kevin Sullivan had the pride of a guy showing off his new Cadillac. But it wasn’t a car he was displaying, it was the new laboratory that his company had recently moved into.
The company is Halifax-based drug discovery outfit Appili Therapeutics Inc., which in May announced $3.3 million in funding, comprising equity, debt and grants. On the same day, Sullivan unveiled the company’s new lab in the Innovacorp Enterprise Centre in Halifax and introduced the team of PhDs working for the company. A month earlier, Appli had announced it received a special fast-track approval designation from the Food and Drug Administration.
Not bad for a company that began last year.
“Appili is a company that hasn’t been around long, and coming from where they started to where they are today is truly impressive,” said Scott Moffitt, the Managing Director of BioNova, the life sciences industry association in Nova Scotia.
Appili is a notable company because of its leadership, its strategy and the story of how the company came together. Sullivan is a businessman operating in a segment that is often known for the high concentration of academics. He’s raised more than $40 million for various companies, and he brings a deep expertise in developing new drugs.
Sullivan came to Nova Scotia in 2013 to take the helm at DeNovaMed, a Halifax company working on a cure for antibiotic-resistant viruses. He had previously spent 10 years (including four as COO) with London-based Viron Therapeutics Inc., which was developing a cardiovascular drug. Viron raised more than $35 million in equity and non-dilutive capital and took its lead product through Phase 2 trials.
During his work in the biotech field, Sullivan met up with Brian Bloom and Jolyon Burton, the principals of the Toronto-based healthcare-focused investment boutique Bloom Burton & Co. Together, they decided to form a company in Halifax headed by Sullivan that would develop drug candidates.
The first is ATI-1501, which aims to remove the nasty taste from an existing drug that treats Clostridium difficile infection, or CDI, an urgent antibiotic-resistant bacterial threat that causes 29,000 deaths annually. A drug called Metronidazole has been used to treat the condition since the 1970s, but kids with CDI don’t want to take it because of its dreadful taste. ATI-1501 removes the bitter taste.
The Food and Drug Administration recently granted orphan drug designation to ATI-1501, meaning Appili could have an accelerated regulatory path and protection against competition for seven years. The company expects to begin clinical trials next year and have a product on the market in three or four years.
The second drug candidate is ATI-1503, a drug that could fight deadly infections such as Klebsiella pneumoniae. The media is full of warnings about viruses that are resistant to antibiotics and Sullivan said this drug could help combat them, but it’s a longer, riskier project than the first drug.
“We’re now entering a post antibiotic era, where a common cut could be deadly,” said Sullivan. “That’s what keeps us up at night.”
Sullivan described Appili’s strategy as one based on “hitting home runs and singles.” The idea is that the drug for CDI can get to market quickly, but address a limited market. By selling the product, it could produce a steady income stream. That would help to finance the drug for antibiotic-resistant viruses, which could become a blockbuster drug.
The strategy helped Sullivan attract $2.3 million in equity financing in the latest round — $1.8 million from individuals brought together by Bloom Burton, and $500,000 from Innovacorp. Appili supplemented the raise with funding from theAtlantic Canada Opportunities Agency and NRC Irap.
“This is a seed round,” said Sullivan. “We’ll be looking to go back to the capital markets in the summer and close another round of financing in the fall.”]]>
Apr 12, 2016 | Appili Therapeutics, News
See original post here
HALIFAX, Nova Scotia – April 12, 2016 – Appili Therapeutics Inc., an anti-infective pharmaceutical development company, announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for ATI-1501, a taste-masked reformulation of metronidazole with the potential to effectively treat Clostridium difficile infection (CDI) in children.
CDI is one of the U.S. Centers for Disease Control’s most urgent antibiotic-resistant bacterial threats. CDI affects over half a million Canadians and Americans each year. It reoccurs in 83,000 patients and is responsible for 29,000 deaths annually. The incidence of CDI in children has been steadily increasing over recent years, and thus a taste-masked metronidazole formulation is urgently needed for this population.
“The bitter metronidazole tablet is highly unpalatable for most children, so ATI-1501 has the potential to fundamentally improve compliance rates for these patients who are in need of a safe and effective treatment for CDI,” said Kevin Sullivan, CEO of Appili Therapeutics.
The FDA Orphan Drug Act provides orphan status to new drugs that are defined as those intended for the safe and effective treatment, diagnosis, or prevention of rare diseases that affect less than 200,000 people in the United States. This orphan drug designation provides Appili with several benefits, including seven years of marketing exclusivity upon approval of ATI-1501, reduced FDA application and administration fees and tax credits for clinical research in the U.S.
“In just 3 months, we received orphan drug designation from the FDA,” continued Mr. Sullivan. “Having this quick turnaround is an indication of the high quality of the regulatory team we have built, and an important step on our path to becoming the first company to offer an approved treatment for C. difficile designed specifically for children affected by this serious infection.”
About Appili Therapeutics
Appili is dedicated to identifying, acquiring and advancing novel therapeutics in the area of infectious disease and has commenced development on two anti-infective programs, while continuing its search to acquire additional high quality anti-infective programs at all stages of development. The company plans to take its lead drug candidate, ATI-1501, a potential treatment for C. difficile infection, into clinical trials by 2017. Appili’s second product, ATI-1503, is a novel antibiotic with the potential to treat deadly infections such as Klebsiella pneumoniae. These drug-resistant Gram-negative bacterial infections have been identified by the U.S. Center for Disease Control (CDC) as posing the highest threat to human health. Appili is co-founded and backed by the life-science/healthcare investment bank Bloom Burton & Co. For more information visit www.AppiliTherapeutics.com.
Media Relations Contact:
Jennifer Cameron
T: 902-209-4704
E: [email protected]
