MEI Pharma Inc (NASDAQ:MEIP), an oncology company focused on the clinical development of novel therapies for cancer, announced new clinical data from a first-in-human study of MEI Pharma’s investigational drug candidate, ME-401, a next generation oral PI3K delta inhibitor. The data, presented today at the American Association for Cancer Research (AACR) Annual Meeting inNew Orleans, suggest that ME-401 has an excellent pharmacokinetic (PK) and pharmacodynamic (PD) profile and the potential for an improved therapeutic window compared to other PI3K delta inhibitors, including the approved drug idelalisib (marketed as Zydelig®), with a half-life that supports once-daily dosing.
“PI3K delta is a class of drugs that has shown great promise in the treatment of B-cell malignancies, but with certain toxicities,” said Daniel P. Gold, Ph.D., President and Chief Executive Officer of MEI Pharma. “We believe this provides an opportunity for a next-generation drug that can produce therapeutic responses at a safe, effective dose. Thus far, ME-401 has demonstrated all of the attributes we had hoped to see, including linear PK and on-target activity at very low concentrations. Now the goal of our upcoming Phase Ib study will be to show a large therapeutic window in cancer patients. We expect to dose the first patient in this study by the end of June and look forward to providing an update later this year.”
The Phase I study was designed to assess the safety and tolerability of ME-401 after single ascending oral doses in healthy volunteers to select the most appropriate dose for further clinical evaluation. The open label study enrolled a total of 15 healthy volunteers in 10, 30, 60, 90 and 150 mg dose levels. ME-401 was well tolerated at all dose levels. One subject experienced two treatment-emergent adverse events that were considered drug-related: pain and headache, graded as mild, after a 60 mg dose.
The first-in-human study of ME-401 was conducted using Quotient Clinical’s Translational Pharmaceutics® platform, which collected PK PD data immediately after each dose and allowed for real-time decision making and manufacturing between dose groups. (Original Source)
Shares of MEI Pharma are up nearly 5% to $1.60 in pre-market trading. MEIP has a 1-year high of $2.44 and a 1-year low of $0.87. The stock’s 50-day moving average is $1.29 and its 200-day moving average is $1.48.
On the ratings front, Wedbush analyst David Nierengarten reiterated a Hold rating on MEIP, with a price target of $2, in a report issued on April 18. The current price target implies an upside of 30.7% from current levels. According to TipRanks.com, Nierengarten has a yearly average return of 34%, a 49% success rate, and is ranked #25 out of 3812 analysts.
MEI Pharma, Inc. is an oncology company, which focuses on the clinical development of novel small molecules for the treatment of cancer. The company currently focuses on the clinical development of two drug candidates, PWT143 and ME-344. MEI Pharma was founded on December 1, 2000 and is headquartered in San Diego, CA.