MATINAS BIOPHARMA HOLDINGS, INC. (OTCMKTS:MTNB) Files An 8-K Other Events
Item 8.01 Other Events to the Companys Current Report on Form 8-K
submitted on June 26, 2017.
| Item 7.01 | Regulation FD Disclosure. |
On June 26, 2017, Matinas BioPharma Holdings, Inc. (the Company)
issued a press release to report topline data from its Phase 2
safety, tolerability and efficacy study of MAT2203 in women with
moderate to severe vulvovaginal candidiasis (VVC). The press
release is attached hereto as Exhibit 99.1.
In accordance with General Instruction B.2 of Form 8-K, the
information in this Item 7.01 of this Current Report on Form 8-K,
including Exhibit 99.1, shall not be deemed filed for the
purposes of Section 18 of the Securities Exchange Act of 1934, as
amended (the Exchange Act), or otherwise subject to the
liabilities of that section, nor shall it be deemed incorporated
by reference in any filing under the Exchange Act or the
Securities Act of 1933, as amended, except as shall be expressly
set forth by specific reference in such a filing.
| Item 8.01 | Other Events. |
The Company reported topline data from its Phase 2 safety,
tolerability and efficacy study of MAT2203 in women with moderate
to severe vulvovaginal candidiasis (VVC). The Phase 2 study
achieved its primary endpoint in demonstrating MAT2203 is safe
and well tolerated. However, both the clinical and mycological
responses for MAT2203 did not meet the Companys expectations and
were below that of fluconazole, the guideline recommended therapy
for the treatment of VVC.
This completed proof-of-concept Phase 2 study of MAT2203 was a
multi-center, randomized trial with the primary objective to
evaluate the safety of two orally administered doses (200 mg and
400 mg) of MAT2203 compared to 150 mg of fluconazole in 137 women
in the safety population. Secondary efficacy objectives were to
assess the clinical cure rate and the mycological eradication
rate of oral CAMB at the test of cure visit (Day 12) compared
with fluconazole in 79 women with confirmed vulvovaginal
candidiasis at baseline in the modified intent to treat
population, and tertiary objectives were to assess
pharmacokinetics (PK) of CAMB after 5 days of oral
administration.
There were no serious adverse events reported in the study and
the majority of treatment emergent adverse events (TEAEs) were
mild in severity and unrelated to study drug. Drug-related TEAEs
of orally-delivered encochleated amphotericin B should be
evaluated in the context of the side effects of IV-administered
unencochleated amphotericin B, which is well known for its severe
and potentially lethal side effects. Drug-related TEAEs occurred
in only 20% of 200 mg patients and 18% of 400 mg patients. The
most frequently occurring drug-related TEAEs in the MAT2203
groups were gastrointestinal and mild in nature. Drug-related
TEAEs occurred in 2% of patients on fluconazole.
Efficacy endpoints included evaluation of clinical and
mycological response. Clinical response was evaluated using a
composite scoring system that compared signs and symptoms of VVC
from baseline to test of cure (Day 12). Signs and symptoms
included itching, burning, irritation, erythema, edema, or
excoriation. MAT2203 demonstrated a clinical cure in 52% of
patients at 200 mg/day and 55% of patients at 400 mg/day,
compared to 75% of patients on fluconazole. In the mycology
outcome, 36% of patients in the 200 mg arm and 32% in the 400 mg
arm experienced eradication, compared to 84% of patients in the
fluconazole arm. In the composite clinical cure score of signs
and symptoms at Day 12, MAT2203 demonstrated an 81% improvement
in clinical symptoms at 200 mg/day, 80% improvement at 400
mg/day, compared to 94% improvement in clinical symptoms for the
patients on fluconazole.
| Item 9.01 | Financial Statements and Exhibits. |
| (d) | ExhibitNo. | Description. | ||
| 99.1 |
Press Release, dated June 26, 2017 (Current Report on Form 8-K submitted on June 26, 2017). |
About MATINAS BIOPHARMA HOLDINGS, INC. (OTCMKTS:MTNB)
Matinas BioPharma Holdings, Inc. is a clinical-stage biopharmaceutical company. The Company is engaged in identifying and developing therapeutics for the treatment of serious and life-threatening infections. It is engaged in developing a pipeline of product and development candidates, with an initial focus on serious fungal and bacterial infections. Its cochleate delivery technology platform is designed for the targeted delivery of pharmaceuticals directly to the site of infection or inflammation. Its MAT 2203 is an oral formulation of a spectrum anti-fungal drug called amphotericin B, which uses its cochleate delivery technology. Its MAT2501 is an orally administered, encochleated formulation of the spectrum aminoglycoside antibiotic amikacin, which may be used to treat different types of multidrug-resistant bacteria, including non-tubercular mycobacterial infections (NTM), as well as various multidrug-resistant gram negative and intracellular bacterial infections.