ProMetic Obtains FDA Clearance for Phase 2/3 Trials

It’s been a good start to the week for ProMetic Life Sciences (TSX:PLI; OTCQX:PFSCF), whose share price spiked 3.85 percent on Monday (September 25) after receiving clearance from the US Food and Drug Administration for an upcoming and crucial Phase two and three clinical trials for PBI-4050.
The company’s oral anti-fibrotic lead drug candidate will undergo these trials designed to help patients with idiopathic pulmonary fibrosis (IPF).
“We are very excited to be entering the pivotal stages of our IPF clinical program,” Pierre Laurin ProMetic’s president and chief executive officer said.
ProMetic detailed the phase 2 study would enroll 375 patients with IPF on a randomized evaluation, while the phase 3 stage will randomize “an additional up to 450 subjects” who will get either nintedanib and placebo or the chosen PBI-4050 dose.
“We have multiple key opinion leaders who have expressed a wish to participate in the study, and now that the IND has been cleared we can begin a formal study startup,” Dr. John Moran, ProMetic’s chief medical officer said in the company’s statement.

Analyst’s take on ProMetic

On Monday it was reported ProMetic retained its “Buy” rating from Canaccord Genuity analyst Neil Maruoka. The analyst also gave the company a target price of $4.25. At the close on Monday, ProMetic’s shares were priced at $1.62.
Moreover, we believe the adaptive study design could represent an abbreviated path to commercialization in this potential blockbuster indication,” Maruoka indicated according to reporting from Analyst Ratings.
In August, the company received a 20.97 percent bump to its stock thanks to the “Rare Pediatric Disease” designation from the FDA for Ryplazimä, a plasminogen drug which had already received both an “Orphan Drug” and “Fast Track” status.
“The pediatric designation also provides an important incentive for ProMetic to continue developing therapies addressing unmet medical needs for children with rare diseases,” Laurin said in the company’s announcement.
ProMetic also indicated it will follow this approval with clinical trial applications in Canada, Europe, Australia, and Japan throughout the rest of the year.

Investor Takeaway

ProMetic has suffered a substantial decline so far in the year, however, this new approval bodes well for the future of the company. If successful and the company receives approval for PBI-4050, their stock could elevate back to the levels it had seen earlier in the year.
On a year-to-date basis, ProMetic has suffered a 26.91 percent decrease on the TSX. On the OTC, ProMetic’s stock hasn’t fared that much better, declining 20.4 percent.
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Securities Disclosure: I, Bryan Mc Govern, hold no investment interest in any of the companies mentioned.