On February 21, 2018 Prometic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) ("Prometic") reported an update regarding its clinical development programs and confirmation of its priorities regarding its lead drug candidates (Press release, ProMetic Life Sciences, FEB 21, 2018, View Source [SID1234524104]).
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PBI-4050 And Follow-On Analogs, PBI-4547 & PBI-4425
"Idiopathic pulmonary fibrosis (IPF) is now priority No.1 for PBI-4050" stated Pierre Laurin, President and CEO of Prometic. "IPF remains to this day a significant unmet medical need affecting hundreds of thousands of patients with an established market value measured in $billions. The clinical efficacy demonstrated so far in multiple phase 2 clinical trials combined with an impressive safety and tolerability profile gives us great confidence in PBI-4050’s ability to efficiently address fibrotic diseases."
Following the outcome of the successful clinical development Type C meeting held with the FDA in early January 2018, the top clinical development program priority is now the phase 3 pivotal clinical trial for PBI-4050 in patients with idiopathic pulmonary fibrosis (IPF). The all comers study will enroll patients with mild-to-moderate IPF, regardless of whether they are on background standard of care with nintedanib (OFEV) or not and will provide efficacy data on both PBI-4050 as a stand-alone agent, and as an add-on to nintedanib, and will be part of the dataset to support a simple, all-inclusive indication for the treatment of IPF. This multinational study, involving multiple sites across the United States, Canada, Australia, the UK and Europe is expected to begin patient enrollment around the 2018 mid-year mark.
Following last year’s confirmation that beneficial clinical effects are sustained during prolonged treatment in subjects suffering from Alström Syndrome in the United Kingdom, further extensions of duration of treatment were announced to Prometic’s on-going phase 2 open label clinical trial. Prometic now announces that it is formally seeking meetings with both the European and the US regulatory authorities to determine the clinical- regulatory pathway for this condition as a stand-alone indication.
Pierre Laurin stated: "We will soon be disclosing further clinical data from the on-going Alström Syndrome clinical trial in the UK which also gives us great confidence to pursue this devastating condition as a stand-alone fibrosis indication to be treated with PBI-4050. Safety and efficacy data collected and demonstrated to date in such a challenging patient population will also contribute to the clinical design and potential treatment for future clinical development initiatives of the Corporation with respect to indications such as heart, kidney & liver fibrosis".
As part of this realignment, the Corporation has terminated PBI-4050 clinical trial in Cystic Fibrosis Related Diabetes ("CFRD") and is evaluating the need to continue other on-going clinical programs with PBI-4050. Prometic is evaluating its clinical development strategy regarding follow-on compounds (i.e. analogs of PBI-4050) which share the same unique mechanism of action with PBI-4050, have demonstrated similar performance in multiple preclinical studies and some of which have outperformed PBI-4050 in specific animal models. Clinical development of those analogs would enable Prometic to target other fibrotic-related indications and create further therapeutic products optionality for our on- going partnering discussions.
These realignments therefore include: The commencing of PBI-4547’s clinical program includes the initiation of the phase 1 clinical trial in Q2 2018 followed by a phase 2 in patients with liver fibrosis and metabolic diseases. It further includes the initiation of PBI- 4425’s clinical program which is scheduled to commence in H2 2018 with specific targeted indications to be communicated in H2 2018.
RyplazimTM For Plasminogen Deficiencies
RyplazimTM (plasminogen) is the first biopharmaceutical expected to be launched commercially pending the review of its BLA (Biologic License Application) submitted to the FDA initially for the treatment of congenital plasminogen deficiency.
The Company will prioritize the expansion of clinical indications for RyplazimTM and leverage the positive clinical experience gained by supplementing plasminogen levels in deficient patients. There are several medical conditions, some of which potentially lethal, associated with "acquired plasminogen deficiencies" and Prometic is designing clinical trials to establish optimal dosing protocols for the potential use of RyplazimTM for the treatment of such conditions, including thrombotic events as well as acute exacerbations in patients with acute respiratory distress syndrome (ARDS) and/or IPF.
Clinical trials with sub-cutaneous Plasminogen in patients with diabetic foot ulcers and in patients with Tympanic perforations are also currently being conducted in Sweden with expected interim clinical data readouts later this year.
The expenses related to the IVIG non-inferiority phase 3 clinical trial will decrease in 2018 with the completion in H1 2018 of the adults’ cohort required for the FDA BLA filing to be followed by the completion of the pediatric cohort in H1 2019.
Commenting on the financing strategy required to execute on these plans, Bruce Pritchard, Prometic’s CFO noted, "At this stage in its development, the Corporation requires a financing strategy that allows it to maintain adequate capitalization as it continues to build enterprise value with its strong pipeline of therapeutics, but that also recognizes the need for a combination of: generating revenue through product sales; generating revenue from leveraging the asset base, such as licensing technologies for non-core indications or geographies and monetizing priority review vouchers; effective use of debt and synthetic royalty structures and by accessing capital from long-term institutional investors under the best possible conditions". He added, "Each element of this plan is critical, and is being actively pursued by management. Investors should be assured that no single component of the strategy is been seen as mutually exclusive to another. Most importantly, all components need to be readily deployable as required, as we continue to plan to execute a timely secondary listing on NASDAQ".
To maintain its flexibility for strategic fund-raising, Prometic has filed a preliminary short form base shelf prospectus (the "Preliminary Shelf Prospectus") with the securities commissions in each of the provinces of Canada.
Mr. Pritchard went on to explain, "The establishment of a shelf prospectus is common practice among our Canadian and US Peers. Prometic is somewhat unusual for not having one in place. Today’s filing of such a shelf prospectus adds to our armory of financing choices".
The Preliminary Shelf Prospectus, when made final or effective, will allow Prometic to offer up to $250,000,000 of common shares over the 25-month period that the Shelf Prospectus is effective. The Shelf Prospectus will enable Prometic to potentially access new capital as and when needed. The amount and timing of any future offerings will be based on the Company’s financial requirements and market conditions at the time. The specific terms of any future offering under the Shelf Prospectus will be established at the time of such offering. At the time any of the securities covered by the Shelf Prospectus are offered for sale, a prospectus supplement containing specific information about the terms of such offering will be filed with applicable Canadian securities regulatory authorities. The Preliminary Shelf Prospectus filed today with the Canadian securities regulatory authorities has not yet become effective. No securities may be sold, nor may offers to buy be accepted, prior to the time the Preliminary Shelf Prospectus becomes effective. This news release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which an offer, solicitation or sale would be unlawful prior to registration or qualifications under the securities laws of any such jurisdiction. A copy of the Preliminary Shelf Prospectus can be found on SEDAR at www.sedar.com or may be obtained upon request to Prometic’s Investor Relations Department using the contact information set out below.