Compound: Brilacidin
Disease: Acute Bacterial Skin and Skin Structure Infection (ABSSSI)
The intravenous formulation of our lead antibiotic candidate, Brilacidin, has the potential to treat a variety of infections, including Acute Bacterial Skin and Skin Structure Infections (“ABSSSI”), caused by drug-sensitive or drug-resistant strains of Staphylococcus aureus, including Methicillin-Resistant Staphylococcus aureus (MRSA), and by other Gram-positive bacteria.
The Phase 2b trial entitled “A Randomized, Double-Blind Study Comparing Three Dosing Regimens of Brilacidin to Daptomycin in the Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI)” completed enrollment in August 2014. On October 23, 2014, we announced positive top-line efficacy data from this Phase 2b ABSSSI trial, and on January 5, 2015, we reported the corresponding 95% confidence intervals. In April 2015, safety and efficacy results from this 215-patient study of brilacidin in patients with ABSSSI, were presented at the 25th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID).
In July 2015, at an End-of-Phase 2 Meeting, Cellceutix and FDA discussed data supporting advancement into Phase 3, as well as the basic elements of a brilacidin Phase 3 program in ABSSSI. This is the first Host Defense Protein (HDP) mimic to advance through Phase 2. Because HDP mimics, such as Brilacidin, represent an entirely new class of antibiotics, there is no potential cross-resistance with currently marketed antibiotics, and due to its unique mechanism of action, resistance to Brilacidin is unlikely to develop. For this and other reasons, such as its high activity against methicillin-resistantStaphylococcus aureus (a leading cause of ABSSSI) brilacidin received FDA designation as a Qualified Infectious Disease Product (QIDP) in November 2014. The QIDP designation was established as part of the Generating Antibiotic Incentives Now (GAIN) Act, passed by the U.S. Congress in July 2012, for the purpose of encouraging pharmaceutical companies to develop new antimicrobial drugs to treat serious and life-threatening infections. Receiving QIDP designation means that Brilacidin is now eligible for additional FDA incentives in the approval and marketing path, including Fast Track designation and Priority Review for development and a five-year extension of market exclusivity.
The Phase 3 ABSSSI program would include two Phase 3 ABSSSI studies, as required by FDA Guidance (October 2013). In addition, the first study would include an interim analysis after a portion of the patients has been enrolled. This would provide an early assessment of both safety and efficacy. As part of the agreement, the Company would submit a Pediatric Study Plan (PSP) within 60 days of the End-of-Phase 2 Meeting. The Company is currently evaluating potential Contract Research Organizations (CROs) and clinical sites for the global Phase 3 program.
Compound: Brilacidin
Disease: Oral Mucositis
In animal models of oral mucositis induced by chemoradiation, topically applied Brilacidin was shown to significantly reduce the occurrence of severe ulcerative oral mucositis by more than 90% compared to placebo. Brilacidin and related compounds have shown antibacterial, anti-biofilm and anti-inflammatory properties in various pre-clinical studies. We believe that the combination of these attributes contributed to the efficacy of Brilacidin in these animal studies. In December 2013, the Company filed an application with the U.S. Food and Drug Administration requesting Orphan Drug designation for Brilacidin as a drug candidate for the prevention of oral mucositis in patients with head and neck cancer undergoing chemoradiation treatment. The FDA advised the Company that the data indicate that Brilacidin could not only treat patients to prevent and/or lessen the severity of radiation-induced OM but potentially also be efficacious in patients with chemotherapy-induced OM. Therefore the target population for Brilacidin-OM would exceed the number of patients qualifying for orphan drug designation.
In September 2014, Cellceutix filed an IND (Investigational New Drug) application for a planned clinical trial titled “Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Brilacidin Oral Rinse Administered Daily for 7 Weeks in Attenuating Oral Mucositis in Patients with Head and Neck Cancer Receiving Concurrent Chemotherapy and Radiotherapy”. On October 13, 2014 Cellceutix announced the acceptance of its IND (Investigational New Drug Application) by the FDA for evaluation of Brilacidin in the prevention or attenuation of oral mucositis.
In August 2015, Cellceutix announced the addition of two clinical sites for the Company’s ongoing Phase 2 clinical trial of Brilacidin-OM for the treatment and prevention of oral mucositis in patients with head and neck cancer, bringing the total number of sites in the study to date to five. Increasing patient access to the trial is important in the Company’s efforts to discover an effective, safe therapy for oral mucositis, and to prove the anti-inflammatory properties of Brilacidin in a clinical setting. Laboratory studies have shown Brilacidin to have both antibacterial and anti-inflammatory properties.
OM represents a great area of unmet medical need and is potentially a very important and valuable asset in the Brilacidin development pathway.
Compound: Brilacidin
Disease: Ulcerative Proctitis/Colitis
Given its unique immunomodulatory properties, we have also identified inflammatory gastrointestinal (GI) disease as an indication for treatment with Brilacidin. We are now reviewing our clinical strategy and have considered advancing a topical version of Brilacidin into a European Phase 2 trial to evaluate remission of ulcerative proctitis, an idiopathic mucosal inflammatory disease and a form of ulcerative colitis involving only the rectum or the distal colon and rectum (proctosigmoiditis). The Company will determine whether to advance this program only upon review of preliminary results in the oral mucositis trial.
Compound: Brilacidin or Other HDP Mimics
Disease: Hidradenitis Suppurativa
Again, due to the unique immunomodulatory properties of the HDP mimics, along with inherent antimicrobial activity, the Company had planned to conduct a Phase 2 clinical trial of topical HDP mimic for the treatment of hidradenitis suppurativa (HS). Also known as acne inversa, HS is a chronic and debilitating inflammatory skin disease characterized by recurrent abscesses and formation of sinus tracts, typically where skin rubs together, such as the armpits, groin, between the buttocks and under the breasts. First described 176 years ago, there still is no cure and only limited effective treatment options. Reports of prevalence range widely from approximately one-half a percent up to approximately four percent of the general population. HS presents in many forms, and though considered an inflammatory condition, bacteria may play a role. In fact, studies have shown a number of hard-to-treat bacterial species are commonly isolated from HS lesions--bacteria our novel compounds are active against. After careful consideration, we have now cancelled a scheduled May pre-IND meeting with the FDA to discuss initiating a Phase 2 trial for HS. The Company will determine whether to advance this program only upon review of preliminary results in the oral mucositis trial.
Compound: Brilacidin or Other HDP Mimics
Topical Applications, Ophthalmic, and Otic Infections and Related Formulation Work
Cellceutix is formulating and conducting preclinical experiments on topical Brilacidin for use in topical applications such as diabetic foot ulcer infections, and for ear-related infections, such as otitis externa or draining otitis media. We have put on hold formulation development for ophthalmic (eye) infections, including keratitis and conjunctivitis because of the difficulty of Brilacidin to pass cell barriers to the back of the eye. On July 14, 2014, the Company announced that a significant breakthrough had been made in the formulation of Brilacidin. Previously, Brilacidin was stored in a refrigerated state. The Company has now developed the formulation of Brilacidin to be stable at room temperature. However, further formulation work is still needed for each indication. Upon developing optimal formulations, the Company plans to advance these drugs into the clinical trials. The Company believes this work, though challenging, is very important.
Disease: Acute Bacterial Skin and Skin Structure Infection (ABSSSI)
The intravenous formulation of our lead antibiotic candidate, Brilacidin, has the potential to treat a variety of infections, including Acute Bacterial Skin and Skin Structure Infections (“ABSSSI”), caused by drug-sensitive or drug-resistant strains of Staphylococcus aureus, including Methicillin-Resistant Staphylococcus aureus (MRSA), and by other Gram-positive bacteria.
The Phase 2b trial entitled “A Randomized, Double-Blind Study Comparing Three Dosing Regimens of Brilacidin to Daptomycin in the Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI)” completed enrollment in August 2014. On October 23, 2014, we announced positive top-line efficacy data from this Phase 2b ABSSSI trial, and on January 5, 2015, we reported the corresponding 95% confidence intervals. In April 2015, safety and efficacy results from this 215-patient study of brilacidin in patients with ABSSSI, were presented at the 25th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID).
In July 2015, at an End-of-Phase 2 Meeting, Cellceutix and FDA discussed data supporting advancement into Phase 3, as well as the basic elements of a brilacidin Phase 3 program in ABSSSI. This is the first Host Defense Protein (HDP) mimic to advance through Phase 2. Because HDP mimics, such as Brilacidin, represent an entirely new class of antibiotics, there is no potential cross-resistance with currently marketed antibiotics, and due to its unique mechanism of action, resistance to Brilacidin is unlikely to develop. For this and other reasons, such as its high activity against methicillin-resistantStaphylococcus aureus (a leading cause of ABSSSI) brilacidin received FDA designation as a Qualified Infectious Disease Product (QIDP) in November 2014. The QIDP designation was established as part of the Generating Antibiotic Incentives Now (GAIN) Act, passed by the U.S. Congress in July 2012, for the purpose of encouraging pharmaceutical companies to develop new antimicrobial drugs to treat serious and life-threatening infections. Receiving QIDP designation means that Brilacidin is now eligible for additional FDA incentives in the approval and marketing path, including Fast Track designation and Priority Review for development and a five-year extension of market exclusivity.
The Phase 3 ABSSSI program would include two Phase 3 ABSSSI studies, as required by FDA Guidance (October 2013). In addition, the first study would include an interim analysis after a portion of the patients has been enrolled. This would provide an early assessment of both safety and efficacy. As part of the agreement, the Company would submit a Pediatric Study Plan (PSP) within 60 days of the End-of-Phase 2 Meeting. The Company is currently evaluating potential Contract Research Organizations (CROs) and clinical sites for the global Phase 3 program.
Compound: Brilacidin
Disease: Oral Mucositis
In animal models of oral mucositis induced by chemoradiation, topically applied Brilacidin was shown to significantly reduce the occurrence of severe ulcerative oral mucositis by more than 90% compared to placebo. Brilacidin and related compounds have shown antibacterial, anti-biofilm and anti-inflammatory properties in various pre-clinical studies. We believe that the combination of these attributes contributed to the efficacy of Brilacidin in these animal studies. In December 2013, the Company filed an application with the U.S. Food and Drug Administration requesting Orphan Drug designation for Brilacidin as a drug candidate for the prevention of oral mucositis in patients with head and neck cancer undergoing chemoradiation treatment. The FDA advised the Company that the data indicate that Brilacidin could not only treat patients to prevent and/or lessen the severity of radiation-induced OM but potentially also be efficacious in patients with chemotherapy-induced OM. Therefore the target population for Brilacidin-OM would exceed the number of patients qualifying for orphan drug designation.
In September 2014, Cellceutix filed an IND (Investigational New Drug) application for a planned clinical trial titled “Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Brilacidin Oral Rinse Administered Daily for 7 Weeks in Attenuating Oral Mucositis in Patients with Head and Neck Cancer Receiving Concurrent Chemotherapy and Radiotherapy”. On October 13, 2014 Cellceutix announced the acceptance of its IND (Investigational New Drug Application) by the FDA for evaluation of Brilacidin in the prevention or attenuation of oral mucositis.
In August 2015, Cellceutix announced the addition of two clinical sites for the Company’s ongoing Phase 2 clinical trial of Brilacidin-OM for the treatment and prevention of oral mucositis in patients with head and neck cancer, bringing the total number of sites in the study to date to five. Increasing patient access to the trial is important in the Company’s efforts to discover an effective, safe therapy for oral mucositis, and to prove the anti-inflammatory properties of Brilacidin in a clinical setting. Laboratory studies have shown Brilacidin to have both antibacterial and anti-inflammatory properties.
OM represents a great area of unmet medical need and is potentially a very important and valuable asset in the Brilacidin development pathway.
Compound: Brilacidin
Disease: Ulcerative Proctitis/Colitis
Given its unique immunomodulatory properties, we have also identified inflammatory gastrointestinal (GI) disease as an indication for treatment with Brilacidin. We are now reviewing our clinical strategy and have considered advancing a topical version of Brilacidin into a European Phase 2 trial to evaluate remission of ulcerative proctitis, an idiopathic mucosal inflammatory disease and a form of ulcerative colitis involving only the rectum or the distal colon and rectum (proctosigmoiditis). The Company will determine whether to advance this program only upon review of preliminary results in the oral mucositis trial.
Compound: Brilacidin or Other HDP Mimics
Disease: Hidradenitis Suppurativa
Again, due to the unique immunomodulatory properties of the HDP mimics, along with inherent antimicrobial activity, the Company had planned to conduct a Phase 2 clinical trial of topical HDP mimic for the treatment of hidradenitis suppurativa (HS). Also known as acne inversa, HS is a chronic and debilitating inflammatory skin disease characterized by recurrent abscesses and formation of sinus tracts, typically where skin rubs together, such as the armpits, groin, between the buttocks and under the breasts. First described 176 years ago, there still is no cure and only limited effective treatment options. Reports of prevalence range widely from approximately one-half a percent up to approximately four percent of the general population. HS presents in many forms, and though considered an inflammatory condition, bacteria may play a role. In fact, studies have shown a number of hard-to-treat bacterial species are commonly isolated from HS lesions--bacteria our novel compounds are active against. After careful consideration, we have now cancelled a scheduled May pre-IND meeting with the FDA to discuss initiating a Phase 2 trial for HS. The Company will determine whether to advance this program only upon review of preliminary results in the oral mucositis trial.
Compound: Brilacidin or Other HDP Mimics
Topical Applications, Ophthalmic, and Otic Infections and Related Formulation Work
Cellceutix is formulating and conducting preclinical experiments on topical Brilacidin for use in topical applications such as diabetic foot ulcer infections, and for ear-related infections, such as otitis externa or draining otitis media. We have put on hold formulation development for ophthalmic (eye) infections, including keratitis and conjunctivitis because of the difficulty of Brilacidin to pass cell barriers to the back of the eye. On July 14, 2014, the Company announced that a significant breakthrough had been made in the formulation of Brilacidin. Previously, Brilacidin was stored in a refrigerated state. The Company has now developed the formulation of Brilacidin to be stable at room temperature. However, further formulation work is still needed for each indication. Upon developing optimal formulations, the Company plans to advance these drugs into the clinical trials. The Company believes this work, though challenging, is very important.
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