RECENT NEWS ITEMS
Antibe completes ATB-346 validation studies
2015-12-21 08:42 ET - News Release
Mr. Dan Legault reports
ANTIBE THERAPEUTICS ANNOUNCES COMPLETION OF VALIDATION STUDIES OF ATB-346, PROGRESSION TO PHASE 2 CLINICAL TRIALS
Antibe Therapeutics Inc. has completed the previously announced validation studies being performed on the company's lead drug, ATB-346. These studies were initiated as a consequence of ATB-346 inducing an elevation of liver enzymes in some subjects taking the higher doses of the drug (750 and 1500 mg/day), and were aimed at gaining a better understanding of the drug's potency, absorption, metabolism and excretion characteristics. The results of these studies support progression to Phase 2 of development of this drug in patients with osteoarthritis.
In the first set of studies, as previously announced, the suppression of the activity of the cyclo-oxygenase (COX) enzyme, which accounts for the anti-inflammatory and pain-killing effects of ATB-346 (and all other NSAIDs), was substantially greater and longer lasting than had been predicted from the monitoring of blood naproxen levels. NSAIDs are well known to cause liver damage in some patients when taken at high doses.
In the second set of studies, rats were administered ATB-346, in which the hydrogen sulfide-releasing portion of the molecule was 'tagged' with a radioactive marker, thereby allowing it to be tracked after it was administered to each rat. This enabled monitoring of the excretion of ATB-346 and of its metabolites, and any accumulation of the drug in particular organs (such as the liver). There was no significant retention or accumulation of the radiolabel in any tissues, with more than 99% being excreted in urine. In rats treated daily with ATB-346 for four days, less than one-tenth of 1% of the radiolabel remained in the liver 8 hours after the final administration of the drug. Additionally, levels of retention of the radiolabel in other organs, including the kidney, stomach, small intestine and lungs, were extremely low. These studies also identified a number of metabolites of ATB-346, all of which were rapidly cleared.
The results of these studies warrant the continuation of development of ATB-346. They suggest that ATB-346 may be effective at lower doses than previously expected -- doses that were observed to be safe and well tolerated in the Phase 1 study. The studies also suggest that ATB-346 will produce beneficial effects with only once-daily dosing. Accordingly, Antibe plans to move forward with Phase 2 studies and will submit an application to Health Canada in early 2016.
We seek Safe Harbor.
Antibe signs drug licensing deal with Knight
2015-11-16 08:14 ET - News Release
Mr. Dan Legault reports
ANTIBE ENTERS INTO A GUD PRODUCT LICENSING AGREEMENT WITH KNIGHT THERAPEUTICS
Antibe Therapeutics Inc. has signed an exclusive long-term licence and distribution agreement with Knight Therapeutics Inc., a leading Canadian specialty pharmaceutical company, for Antibe's anti-inflammatory and pain drugs, ATB-346, ATB-352 and ATB-340, as well as the rights to other, future Antibe prescription drugs.
Under the terms of the license agreement, Antibe has granted Knight the exclusive commercial rights for Antibe's drug candidates and other future prescription drugs in Canada, Israel, Romania, Russia and sub-Saharan Africa. Antibe is entitled to royalties on annual sales, along with the potential for $10 million in payments for sales-based milestones. Antibe considers this a favourable royalty scenario given its competitive anticipated cost-of-goods structure. The global market for non-steroidal anti-inflammatory and pain drugs is more than US$12 billion annually, despite serious side effects for the currently marketed drugs, especially when taken over the long-term. Antibe's drug candidates are novel and patent-protected, and are designed to be safer versions of drugs currently on the market.
Antibe also announced a second closing of the non-brokered private placement of convertible debentures ("Debentures") announced October 16, 2015, bringing the total proceeds to $2.6M. The first tranche of the financing was led by the Bloom Burton Healthcare Lending Trust and the major investor in the second tranche is Knight. The funds will be used to further the development of Antibe's novel anti-inflammatory drug pipeline and to fuel the growth of Antibe following its acquisition of an 85% interest in Citagenix Inc. For further details concerning the Citagenix acquisition, please see Antibe's news releases of October 6, 2015 and October 16, 2015. The Debentures will mature on October 15, 2018, bear interest at a rate of 10% per year, and are convertible at the holder's option into common shares of Antibe at a price of $0.22 per share. In addition, the new holders received an aggregate of 1.6 million warrants to purchase common shares of Antibe at a price of $0.31 which are exercisable until October 15, 2018. The Private Placement remains subject to TSXV final approval.
"The world needs safer anti-inflammatory drugs, and we are pleased to have secured Antibe's innovative portfolio for our territories. We have come to know their management team and are also pleased to provide financial support for their strategic thrust into regenerative medicine," said Jonathan Ross Goodman, President and CEO of Knight. Dan Legault, CEO of Antibe Therapeutics, added "Our recent acquisition of Citagenix has transformed Antibe into an integrated healthcare and biotechnology company with a focus on anti-inflammatory and regenerative medicine, but we continue to need great partners to unlock our full growth potential. We are excited to build a strategic relationship with Knight, a partner with the resources, relationships and know-how to build exceptional companies."
Antibe has also retained BND Projects Inc. ("BND") to provide investor relations services. BND, based in the Greater Toronto Area, was founded by Christina Cameron. Ms. Cameron, a life sciences capital markets expert with over 14 years of experience in investor relations and investment banking, will be providing the services under the agreement. BND and BND's principals have the right and expect, from time to time, to purchase Antibe's securities for investment purposes. The principals of BND currently hold a total of 44,500 shares of Antibe.
The agreement with BND, which is subject to the approval of the TSX Venture Exchange, can be terminated by either party on 30 days prior notice. BND will receive a fee of $5,000 per month plus the granting of 12,000 stock options per quarter in the Company's Stock Option Plan.
We seek Safe Harbor.
Antibe closes Citagenix acquisition, financing tranche
2015-10-16 07:17 ET - News Release
Mr. Dan Legault reports
ANTIBE THERAPEUTICS CLOSES STRATEGIC TRANSACTIONS
Antibe Therapeutics Inc. has completed the acquisition of an 85-per-cent interest in Citagenix Inc., a Montreal-based sales and distribution company with a focus on regenerative medicine, and a first closing of its non-brokered private placement of convertible debentures and warrants. The Citagenix acquisition and the private placement were previously announced in Antibe's news release of Oct. 6, 2015.
Antibe purchased 85 per cent of the common shares and 100 per cent of the preferred shares of Citagenix. The Citagenix share vendors have entered into lock-up agreements respecting the Antibe common shares that they received as consideration, with 25 per cent of such shares to be released today, and an additional 25 per cent to be released six months, nine months and 12 months from today's closing. Antibe has agreed to purchase the remaining common shares of Citagenix subject to that vendor clearing a personal information form (PIF) with the TSX Venture Exchange. Further information concerning the vendor of the remaining Citagenix shares will be disclosed in a subsequent news release following clearance of the PIF.
Antibe also completed today a first closing of its non-brokered private placement of senior secured convertible debentures and warrants to the Bloom Burton Healthcare Lending Trust raising gross proceeds of $1.8-million. The debentures have a term of three years, bear interest at a rate of 10 per cent per year, are convertible at the option of the holder into common shares of Antibe at a price of 22 cents per share and are secured by the assets of Antibe. Purchasers of the debentures were issued an aggregate of 3.6 million warrants to purchase common shares of Antibe. The warrants are each exercisable for the purchase of one common share of Antibe at a price of 31 cents for a period of three years. The debentures, the warrants and the underlying shares are subject to a securities law hold period expiring on Feb. 16, 2016.
For further details concerning the Citagenix acquisition and the private placement, please see Antibe's news release of Oct. 6, 2015.
The Citagenix acquisition and the offering of the convertible debentures and warrants are subject to the final approval of the TSX Venture Exchange.
Antibe Therapeutics finalizes report on ATB-346 studies
2015-08-10 07:11 ET - News Release
Mr. Dan Legault reports
ANTIBE ANNOUNCES COMPLETION OF PHASE I STUDIES OF ATB-346 AND AN UPDATE ON ITS VALIDATION STUDIES
Antibe Therapeutics Inc.'s report on its phase 1 studies of ATB-346, its lead drug, has been finalized. This milestone permits Antibe to proceed, when appropriate, with filing of applications to appropriate regulators for phase 2 studies of ATB-346.
In phase 1, ATB-346 was found to be safe and well tolerated at a daily dose of 250 milligrams for 14 days. At this dose, and doses as low as 75 milligrams daily, ATB-346 markedly inhibited the enzyme cyclooxygenase, which is the target of non-steroidal anti-inflammatory drugs -- the degree of inhibition of COX activity correlates well with reduction of pain and inflammation. The inhibition of COX by ATB-346 persisted for 24 hours after administration, suggesting a once-daily dosing regimen for this drug of 250 milligrams or less.
As recently announced, Antibe's continuing validation studies of ATB-346 are progressing on schedule. These studies are aimed at gaining a better understanding of the absorption, excretion and key metabolites of ATB-346 after oral administration. The studies are being performed by Covance Laboratories in the United States using laboratory rats. The rats were treated with ATB-346 to which a radioactive label had been applied. This allows for tracking of the non-naproxen portion of the drug. The single-dosing portion of the study has been completed; data collected thus far demonstrate that over 93 per cent of the non-naproxen portion of ATB-346 was cleared from the body within 24 hours of oral administration. A multiple-dosing study is in progress. Antibe will continue to keep the market informed of progress in the continuing validation studies, the results of which remain on schedule for the fourth quarter.
We seek Safe Harbor.