Merck gets a PDUFA date for its chronic cough contender; Morphic shares skyrocket on the heels of PhI data rollout in IBD
Merck should know before the end of this year whether or not the FDA will approve its drug gefapixant for chronic cough. The regulator has set a PDUFA date of Dec. 21 for the drug, giving the pharma giant a regular review for a closely watched development program.
Gefapixant is the leader among a group of P2X3 receptor antagonists that are racing to compete for a share of this program. That’s one reason why the agency has informed Merck that it plans to hold an advisory committee for the review.
Merck’s Roy Baynes has described this one as another “pipeline in a product,” but it’s no shoo-in. The drug hit statistical significance on risk reduction, but investigators also flagged high dropout rates due to adverse events in the drug arm. So even with an OK, the pharma giant could soon face rivals angling for better efficacy and a stronger safety profile.
Bayer and Shionogi have competitive programs in the clinic, but the chief rival right now is Bellus, though BLU-5937 failed a Phase II trial. That drug is now in an adaptive Phase IIb. — John Carroll
Morphic shares soar after Phase I readout for novel inhibitor in IBD
On Monday, Waltham, MA-based Morphic Therapeutics unveiled Phase I proof-of-concept data for its oral α4β7 integrin inhibitor MORF-057 in IBD. Turns out investors like that data — a lot.
Morphic $MORF was trading up about 90% early Monday morning on the heels of the news, putting the biotech’s shares in the range of $70.
In the three highest dose cohorts of MORF-057’s Phase I program, the drug showed a mean receptor occupancy of 95%, Morphic said, offering hope that the drug can sufficiently “saturate” the α4β7 integrin.
Morphic is planning a Phase II study based on the early-stage results in ulcerative colitis. Meanwhile, the biotech is running a concurrent food-effect study. — Kyle Blankenship
Chinook hands over upfront payment to launch CKD deal with Evotec
Canada’s Chinook Therapeutics has inked a discovery and development deal with Evotec on new drugs for chronic kidney disease.
In the deal the European CRO is gaining an undisclosed upfront payment, research funds and more as Evotec’s team starts the hunt for new drugs.
“CKD is a collective term for a variety of diseases that cause a gradual loss of kidney function. The diversity in the underlying causes makes this area especially favorable for data-driven and systematically personalized approaches,” said Cord Dohrmann, the CSO of Evotec. “By leveraging our complementary platforms, Evotec and Chinook have the best possible starting position to tackle particular rare forms of CKD with the goal to develop disease-modifying therapeutics for underserved patient populations.”
Back last summer Chinook executed a reverse merger with the struggling Aduro to get onto Nasdaq. The biotech raised more than $100 million to go along with the merger. — John Carroll
Oxular nets $37M to advance once-a-year eye disease treatments
British biotech Oxular Limited completed a new $37 million funding round it hopes to use to finance clinical trials.
The cash will go toward Phase II studies beginning later this year to evaluate the program OXU-001 for the treatment of DME, which Oxular says is the leading cause of blindness in young adults in developed countries. Prominent European VC firm Forbion led the round.
Given that a key challenge for these patients is repeated clinical visits, Oxular has developed OXU-001 to be a sustained-release formulation of dexamethasone that can provide up to 12 months of treatment following a single dose.
Some of the funds will also go toward a Phase II study for a separate candidate in retinoblastoma. Programs for uveal melanoma and age-related macular degeneration and diabetic retinopathy will also be prepped for IND submissions. — Max Gelman
Reata shoots for fast review of its first NDA
After a years-long clinical quest, Plano, TX-based Reata has filed an NDA in search of an approval for bardoxolone in Alport syndrome.
The biotech’s CEO, Warren Huff, adds that they’re shooting for priority review status in an attempt to shorten the FDA’s handling of the NDA by 4 months. This application marks Reata’s first formal shot at an FDA approval.
In an update, Reata also noted plans to revise another clinical study that had been paused due to the pandemic.
We are planning to amend the FALCON protocol to increase the target enrollment from 300 patients to a total of 550 patients. With the planned increase in anticipated enrollment, we expect to complete enrollment in FALCON by the end of 2021.
— John Carroll