UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported)

March 4, 2019

 

 

INTEC PHARMA LTD.

(Exact name of registrant as specified in its charter)

 

 

 

Israel 001-37521 N/A

(State or other jurisdiction

of incorporation)

(Commission File Number)

(IRS Employer

Identification No.)

 

 

12 Hartom St.

Har Hotzvim

   
  Jerusalem, Israel 9777512  
  (Address of principal executive offices) (Zip Code)  
 
+ 972-2-586-4657

(Registrant’s telephone number, including area code)

 

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company  x

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  x

 

 

 

 

 

 


Item 7.01. Regulation FD Disclosure.

 

Intec Pharma Ltd. (the “Company”) is furnishing as Exhibit 99.1 to this Current Report on Form 8-K a slide presentation with respect to the Company’s recently completed Accordion Pill Carbidopa/Levodopa three times daily PK study which the Company intends to use at key opinion leader events and at meetings with the investor community.

 

The furnishing of the slide presentation is not an admission as to the materiality of any information therein. The information contained in the presentation materials is summary information that is intended to be considered in the context of more complete information included in the Company’s filings with the SEC and other public announcements that the Company has made and may make from time to time by press release or otherwise. All information contained in the presentation materials is subject to the disclaimer regarding forward-looking statements at the beginning of the presentation.

 

The information furnished pursuant to this Item 7.01, including Exhibit 99.1, shall not be deemed “filed” for 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, and shall not be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date of this Current Report, regardless of any general incorporation language in any such filing, except as expressly set forth by specific reference in such filing.

 

Item 9.01. Financial Statement and Exhibits.

 

(d) Exhibits.

 

Exhibit No. Description
99.1 Intec Pharma Ltd. Slide Presentation, dated March 2019

 

1 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Date: March 4, 2019

 

  INTEC PHARMA LTD.
   
  By: /s/ Nir Sassi
    Nir Sassi
    Chief Financial Officer

 

2 

 

Exhibit 99.1

 

TID PK Study Nasdaq : NTEC March, 2019

 
 

This presentation by Intec Pharma Ltd . (referred to as “we” or “our”) contains forward - looking statements about our expectations, beliefs and intentions regarding, among other things, our product development efforts, business, financial condition, results of operations, strategies, plans and prospects . In addition, from time to time, we or our representatives have made or may make forward - looking statements, orally or in writing . Forward - looking statements can be identified by the use of forward - looking words such as “believe”, “expect”, “intend”, “plan“, “may“, “should“, “could“, “might“, “seek“, “target“, “will”, “project“, “forecast“, “continue” or “anticipate” or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters . Forward - looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made . Because forward - looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward - looking statements . Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward - looking statements, including those described in the sections entitled “risk factors” in the documents that we file with the Securities and Exchange Commission . We believe these forward - looking statements are reasonable ; however, these statements are only current predictions and are subject to known and unknown risks, uncertainties and other factors that may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from those anticipated by the forward - looking statements . Given these uncertainties, you should not rely upon forward - looking statements as predictions of future events . All forward - looking statements attributable to us or persons acting on our behalf speak only as of the date of this presentation and are expressly qualified in their entirety by the cautionary statements included in this presentation . We undertake no obligations to update or revise forward - looking statements to reflect events or circumstances that arise after the date made or to reflect the occurrence of unanticipated events, except as required by applicable law . In evaluating forward - looking statements, you should consider these risks and uncertainties . The presentation contains information about investigation - stage drug products under development, which have not yet been approved by the FDA for commercial distribution in the United States . All representations in this Presentation are based upon investigations in certain clinical and other research, but which accordingly should not be construed as general claims for the safety or efficacy of the products when used by patients . Forward Looking Statements 2

 
 

• Fluctuating plasma levodopa levels lead to pulsatile stimulation of striatal dopamine receptors • Pulsatile stimulation of DA receptors causes: – Molecular changes in basal ganglia input neurons – Neurophysiologic changes in basal ganglia output neurons – Development of motor complications (motor fluctuations and dyskinesia) Olanow et al, Lancet Neurology 2006 3 Continuous Dopaminergic Stimulation (CDS) Current Concepts

 
 

• It has been hypothesized that continuous delivery of levodopa will restore brain DA in a more physiologic manner • Open label and double blind studies confirm that the risk of motor complications is reduced if the same short - acting dopaminergic agent is delivered continuously rather than intermittently ( Olanow et al, Lancet Neurol 2014) 4 Continuous Dopaminergic Stimulation (CDS) Current Concepts

 
 

Duodopa ® Study – Double - Blind, Double - Dummy. Double - Titration Study Olanow et al, Lancet Neurol 2014 5

 
 

Approaches to CDS in PD Patients • Continuous intrajejunal infusion • Continuous patch delivery • Continuous sc infusion • Continuous intraoral infusion • Oral drugs with long t1/2 6

 
 

The Accordion Pill TM • Multi - layer, planar structure composed of biodegradable films folded into accordion shape placed into a standard size capsule 7

 
 

Intec PK Study • Open label cross - over PK study • 12 subjects • PD consistent with UK Brain Bank Criteria • On stable doses of standard oral levodopa • Day 1 – arrive in clinic in practically defined OFF state – Standard Levodopa PK • Day 2 - 7 – treated with AP – CD/LD 50/500 mg tid • Day 8 - arrive in clinic in practically defined OFF state – AP – Levodopa PK 8

 
 

Intec PK Study – Hospital Protocol • Day 1 – Levodopa PK - study – Standard Levodopa 1.5 25/100mg tabs vid (0, 3, 6, 9, 12 hours) • Day 8 – AP PK - study – AP - CD/LD (Levodopa) 50/500mg tid (0, 5, 10 hours) • PK evaluations – Q 30” from 0 to 16 hours, then at 24 hours 9

 
 

Intec PK Study - Endpoints • Primary Endpoint – Fluctuation Index ( C max - C min )/ C average ) in steady state (4 - 16 hours) • Sensitivity Analyses – Fluctuation Index (4 - 12 hours) – Fluctuation Index – Patients with Complete Data Set – Fluctuation index calculated by 2 hr time blocks (0 - 16 hours ) • Secondary Endpoint – Levodopa Coefficient of Variation (SD/ C average ) in steady state (4 - 16 hours) 10

 
 

Levodopa C oncentration by Time (0 - 16 hours ); S moothed S plines by G roup L - dopa ng /ml 11

 
 

Representative Patient 12

 
 

Primary Endpoint : Fluctuation Index of Plasma Levodopa Concentration in Steady State 13

 
 

Tolerability and Safety • Tolerability – No drop outs • Safety – Day 1: IR - CD/LD PK day • Abdominal Cramps – mild • Diarrhea – mild • Fever • Panic attack – Day 8: AP - CD/LD PK day • No Adverse events reported 14

 
 

Intec PK Study - Summary AP - CD/LD met all primary, sensitivity and secondary endpoints • Primary Endpoint – Fluctuation Index P =0.005 • Sensitivity Analyses – FI - 0 - 12 hour steady state P =0.013 – FI - Completer Data Set P =0.015 – FI – 2 hour time blocks P =0.001 • Secondary Endpoint – Coefficient of Variation P = 0.047 AP - CD/LD was safe and well tolerated 15

 
 

Conclusions • Treatment with the Accordion Pill TM 50/500 mg tid resulted in reduced plasma levodopa variability in comparison to standard oral levodopa treatment • Clinical studies indicate that reduced variability in plasma levodopa is associated with a reduced risk of motor complications – PK is a surrogate for efficacy • The effect of the Accordion Pill on motor complications in PD patients is currently being tested in a Phase 3 study 16