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)

 

July 22, 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))

 

Securities registered pursuant to Section 12(b) of the Act: 

Title of each class   Trading Symbol   Name of each exchange
on which registered
Ordinary Shares, no, par value   NTEC   Nasdaq Capital Market

 

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  ☒

 

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.  ☒

 

 

 

 

 

 

Item 7.01.Regulation FD Disclosure.

 

On July 22, 2019, management of Intec Pharma Ltd. (the “Company”) will hold a conference call and webcast at 8:30 a.m. ET to discuss the top-line results from its Phase III ACCORDANCE clinical trial. A copy of the presentation being used in connection with this conference call is furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein solely for purposes of this Item 7.01 disclosure.

 

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 8.01Other Events.

 

On July 22, 2019, the Company issued a press release announcing top-line results from its Phase III ACCORDANCE clinical trial of AP-CD/LD, a multi-center, global, randomized, double-blind, double-dummy, active-controlled, parallel-group study in adult subjects with advanced Parkinson’s Disease. The study did not meet its primary or secondary endpoints.

 

A copy of the press release is filed as Exhibit 99.2 hereto and is incorporated herein by reference.

 

Item 9.01.Financial Statements and Exhibits.

 

(d)     Exhibits.

 

Exhibit No.   Description
     
99.1   ACCORDANCE Study Presentation dated July 22, 2019
99.2   Press release issued by Intec Pharma Ltd. on July 22, 2019

 

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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: July 22, 2019

 

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

 

 

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Exhibit 99.1

 

Phase 3 ACCORDANCE Study Top - Line Results July 22 , 2019

 

 

This presentation by Intec Pharma Ltd. (referred to as “we” or “our”) may contain forward - looking statements about our expectations, beliefs and intentions regarding, among other things, our product development efforts, business, financial condition, results of operation s, 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“, “s hould“, “could“, “might“, “seek“, “target“, “will”, “project“, “forecast“, “continue” or “anticipate” or their negatives or variations of thes e w ords 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 an y f uture results expressed or implied by the forward - looking statements. In addition, historical results or conclusions from scientific research and clinical studies do not guarantee that future results would suggest similar conclusions or that historical results referred to herein would be interpreted similarly in light of additional research or otherwise. Many factors could cause our actual activities or results to differ materially from the activities and results ant icipated in forward - looking statements, including, but not limited to, the following: our limited operating history and history of operating losses, our abi lity to continue as a going concern, our ability to obtain additional financing, our ability to successfully operate our business or execute our business pl an, the timing and cost of our clinical trials, the completion and receiving favorable results in our clinical trials, our ability to obtain and maintai n r egulatory approval of our product candidates, our ability to protect and maintain our intellectual property and licensing arrangements, our ability to develop, ma nufacture and commercialize our product candidates, the risk of product liability claims, the availability of reimbursement, and the influe nce of extensive and costly government regulation. We believe these forward - looking statements are reasonable; however, these statements are only current predictions and are subje ct to known and unknown risks, uncertainties and other factors that may cause our or our industry’s actual results, levels of activity, perfo rma nce or achievements to be materially different from those anticipated by the forward - looking statements. Given these uncertainties, you should not rely up on 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 even ts, except as required by applicable law. In evaluating forward - looking statements, you should consider these risks and uncertainties. More detailed infor mation about the risks and uncertainties affecting us is contained under the heading “Risk Factors” in the Annual Report and in our period filings w ith the SEC. The presentation contains information about investigation - stage drug products under development, which have not yet been approve d by the FDA for commercial distribution in the United States. All representations in this presentation are based upon investigations in certa in 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 patie nts . Forward Looking Statements 2

 

 

• Parkinson ’ s disease (PD ) results from a continuing loss of dopamine - producing nerve cells. • Dopamine is required for normal functioning of the central nervous system. • Levodopa is generally considered to be the most effective and widely used treatment for Parkinson ’ s disease. • Up to 50 % of patients show the onset of motor fluctuations within two years of starting conventional Levodopa therapy. • For many advanced PD patients, the repeated emergence of OFF periods can occupy up to one - third or more of a typical waking day. • Improving the consistency in Levodopa ’ s plasma levels becomes the major factor for improving symptom control. Parkinson’s Disease and Levodopa

 

 

The Accordion Pill: A new platform for oral drug delivery AP capsule dissolves and outer layers facilitate unfolding mechanism of films Layers comprise an inner, controlled release drug - containing layer, and immediate release layer(s) for multiple drug release profiles and/or fixed - dose combinations Retained in stomach for up to 12 hours, AP releases drug in controlled manner towards upper part of gastrointestinal tract, where it is absorbed Once AP is out of stomach, it is fully degraded in small intestine 4

 

 

AP - CD/LD Phase III Trial Design ~ 9 0+ Clinical sites across 10 countries 6 Weeks 13 Weeks 2 Weeks 50 / 400 , 50 / 500 BID, TID Open label N= 462 Double Blind 12 Months 6 Weeks Optimization on Sinemet® AP - CD/LD Conversion Enrollment Committee Review Treatment Period Sinemet + AP - CD/LD dummy Treatment Period AP - CD/LD + Sinemet dummy Follow Up Open Label Extension AP - CD/LD Randomization N= 320 Enrollment Open label Gastroscopy (GI endoscopy) Gastroscopy (GI endoscopy) First ˜ 100 patients Independent DMC closed GI sub - study in Feb. 2018 and recommended to continue main study without changes 5 > 90 % enrolling

 

 

Primary Analysis - Average Hours of “ OFF ” Time Daily

 

 

Preliminary Post Ad Hoc Analysis - All Patients NOT Requiring The Maximal AP Dose of 1500 mg LD

 

 

Preliminary Post Ad Hoc Analysis - Patients Who Received 1.6 to 2.0 Dose Ratio of AP LD to IR LD

 

 

Thank you www.intecpharma.com

 

 

 

 

Exhibit 99.2

 

 

 

Intec Pharma Reports Top-Line Phase 3 Trial Results of Accordion Pill-Carbidopa/Levodopa in Advanced Parkinson’s Disease Patients

 

Conference Call to begin at 8:30 am ET

 

Jerusalem (July 22, 2019) – Intec Pharma Ltd. (NASDAQ: NTEC) (“Intec” or “the Company”) today announces top-line data from the Company’s pivotal Phase 3 trial (the ACCORDANCE trial) evaluating the safety and efficacy of the Accordion Pill®-Carbidopa/Levodopa (AP-CD/LD) compared with immediate release CD/LD (IR-CD/LD; Sinemet®) as a treatment for the symptoms of advanced Parkinson’s disease (PD). The company announced that the ACCORDANCE study did not achieve statistical superiority to Sinemet on the primary endpoint of reduction in daily OFF time.

 

Levodopa is the most widely used and most effective drug for the symptomatic therapy of PD. However, chronic levodopa therapy is problematic due to the development of motor complications, which can be disabling, difficult to treat, and may limit the usefulness of the drug. OFF periods and dyskinesia are some of the most prevalent motor complications for advanced PD patients and they have a significant impact on quality-of-life and healthcare costs.

 

Key Findings of the ACCORDANCE Trial

 

AP-CD/LD provided treatment for Parkinson’s disease symptoms but did not demonstrate a statistically significant reduction in OFF time over that obtained with IR-CD/LD under the conditions established in the protocol.

 

Treatment-emergent adverse effects (TEAEs) observed with AP-CD/LD were generally consistent with the known safety profile of CD/LD formulations and no new safety issues were observed throughout the double-blinded study, during the gastroscopy safety sub-study or the 12-month open-label extension (OLE) study.

 

“We are disappointed that the ACCORDANCE study didn’t meet its target endpoints with statistical significance. While the data suggests that the AP CD/LD did achieve an acceptable safety profile and did treat Parkinson’s disease symptoms, it did not achieve a statistically significant superiority to standard immediate release levodopa therapy. We are pleased with the good safety profile of the AP-CD/LD, as it demonstrates for the first time the long-term safety of the Accordion Pill, which is important for future potential applications and partnerships,” stated Jeffrey A. Meckler, Vice Chairman and Chief Executive Officer of Intec Pharma.

 

“We sincerely thank the patients, families and clinical trial sites involved in this study for their commitment to advancing research in Parkinson’s disease. We hope the body of clinical data we have gathered can ultimately be used to benefit PD patients,” stated R. Michael Gendreau, Chief Medical Officer of Intec Pharma. “Upon our on-going preliminary review of the data, we have noted that certain subsets of patients performed particularly well. In those patients, we see a meaningful reduction in OFF time. We will continue to analyze the full data set and expect that such findings will help inform our strategy for AP-CD/LD moving forward.”

 

 

 

 

The ACCORDANCE Phase 3 Clinical Trial

 

Study Design

 

The Phase 3 ACCORDANCE study is a multi-center, global, randomized, double-blind, double-dummy, active-controlled, parallel-group study in adult subjects with advanced PD. The study was conducted at over 90 clinical sites throughout the U.S., Europe and Israel. Prior to the 13-week randomized and double-blinded portion of the study, the ACCORDANCE study had two open label periods of 6 weeks each during which all patients in these open label periods were first stabilized and then optimized on the active comparator, Sinemet, and then on AP-CD/LD. The study enrolled 462 patients in the Sinemet titration period to provide for the 320 patients that were randomized into the 13-week, double-blinded portion of the study.

 

All patients completing the 13-week randomized period were eligible to continue in an open-label extension study in which they receive treatment with AP-CD/LD for an additional 12 months. More than 90% of eligible patients elected to enter the OLE study.

 

Primary and Secondary Endpoints

 

The primary efficacy endpoint of the study was the change from baseline to endpoint in the percent of daily OFF time during waking hours based on Hauser home diaries. The study was 90% powered to detect a one-hour difference in OFF time between Sinemet and AP-CD/LD. Under the protocol and conditions of the ACCORDANCE study, AP CD/LD did not demonstrate statistical superiority to Sinemet on daily OFF time.

 

Secondary endpoints include change from baseline to endpoint in ON time without troublesome dyskinesia during waking hours, CGI-I at endpoint (as recorded by physician and patient) and change from baseline through endpoint in the Unified Parkinson’s Disease Rating Scale (UPDRS) Score Parts 2 and 3. AP-CD/LD also did not achieve statistical superiority on these endpoints.

 

Safety and Tolerability

 

Treatment-emergent adverse effects observed with AP-CD/LD were generally consistent with the known safety profile of CD/LD formulations. No new safety issues were observed throughout the double-blinded study, during the gastroscopy safety sub-study or the 12-month open-label extension (OLE) study.

 

Conference Call Information

 

Intec Pharma will hold a conference call and live audio webcast on Monday, July 22, 2019 at 8:30 a.m. Eastern Time to discuss the top-line results of this trial.  To participate, please dial 877-552-1225 (domestic) or 270-215-9857 (international) and refer to conference ID 1575693.  To access the webcast, please click here.

 

The live webcast can also be accessed under “Events and Presentations” in the Investors section of Intec Pharma’s website at www.intecpharma.com.  The archived webcast will be available on the website beginning approximately two hours after the event for 90 days.

 

About the Accordion Pill Technology

 

The Accordion Pill is a drug delivery system that uses biodegradable polymeric films, which combine and load drugs and actives ingredients onto these films, folds them into an undulated shape and then places them inside a capsule.  This innovative drug delivery system has a number of unique advantages based on its gastric retentive properties. With the Accordion Pill, drug is released slowly in the stomach over hours, allowing the body to absorb it more steadily. When the pill is done, it simply dissolves in the GI tract.

 

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About AP-CD/LD

 

The Accordion Pill Carbidopa/Levodopa (AP-CD/LD) is a gastric-retentive drug delivery system containing carbidopa and levodopa in both immediate and extended-release modes. The innovative gastric retentive qualities of AP-CD/LD provide extended-release levodopa to be discharged slowly in the stomach over 8–12 hours, allowing the active ingredients to be absorbed more steadily in the upper GI tract, where levodopa is absorbed.  This results in a more stable and predictable PK profile.

 

About Parkinson’s Disease

 

Parkinson’s disease is the second most common neurodegenerative disorder in the elderly, and it is estimated to affect more than two million people in the U.S. and Europe. There are estimated to be more than 600,000 Parkinson’s disease patients in the U.S. who experience motor fluctuations, a condition where with disease progression patients experience both “wearing off” (where they have trouble with movement), and “dyskinesias” or uncontrolled movements. More than 400,000 of these patients in the U.S. experience in excess of one hour per day of motor fluctuations.

 

The majority of Parkinson’s disease patients are treated with LD. However, LD treatment is often associated with motor complications, mainly wearing “OFF” periods and LD-induced dyskinesia.

 

The efficacy and adverse effects of LD are directly related to plasma levels of the drug.  Current formulations of LD provide only limited efficacy as LD has a very short half-life of approximately 90 minutes and its absorption is confined to the upper part of the gastrointestinal tract (narrow absorption window). Consequently, stabilizing LD plasma levels remains a major factor for improving anti-parkinsonian control in advanced Parkinson’s disease patients.

 

Sinemet® is a registered trademark of Merck & Co., Inc.

 

About Intec Pharma Ltd.

 

Intec Pharma is a clinical-stage biopharmaceutical company focused on developing drugs based on its proprietary Accordion Pill platform technology. The Company’s Accordion Pill is an oral drug delivery system that is designed to improve the efficacy and safety of existing drugs and drugs in development by utilizing an efficient gastric retention and specific release mechanism. The Company’s product pipeline includes two product candidates in clinical trial stages: Accordion Pill Carbidopa/Levodopa, or AP-CD/LD, which is in late-stage Phase 3 development for the treatment of Parkinson’s disease symptoms in advanced Parkinson’s disease patients, and AP-cannabinoids, an Accordion Pill to deliver either or both of the primary cannabinoids contained in Cannabis sativa, cannabidiol (CBD) and tetrahydrocannabinol (THC) for various pain indications. In addition, the Company has a feasibility agreement for the development of a custom-designed Accordion Pill for a proprietary compound with Novartis Pharmaceuticals and a research collaboration with Merck & Co.

 

For more information, visit www.intecpharma.com. Intec Pharma routinely posts information that may be important to investors in the Investor Relations section of its website.

 

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Cautionary Note Regarding Forward-Looking Statements

 

This press release contains forward looking statements about our expectations, beliefs and intentions. 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. These forward-looking statements are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and we undertake no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties, many of which are outside of our control. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to, the following: our limited operating history and history of operating losses, our ability to continue as a going concern, our ability to obtain additional financing, our ability to successfully operate our business or execute our business plan, the timing and cost of our clinical trials, the completion and receiving favorable results in our clinical trials, our ability to obtain and maintain regulatory approval of our product candidates, our ability to protect and maintain our intellectual property and licensing arrangements, our ability to develop, manufacture and commercialize our product candidates, the risk of product liability claims, the availability of reimbursement, and the influence of extensive and costly government regulation. More detailed information about the risks and uncertainties affecting us is contained under the heading “Risk Factors” included in our most recent Annual Report on Form 10-K filed with the SEC on February 27, 2019, and in other filings that we have made and may make with the Securities and Exchange Commission in the future.

 

Intec Pharma Investor Contact:

Anne Marie Fields

VP-Corporate Communications & Investor Relations

646-200-8808

amf@intec-us.com

 

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