Akari Therapeutics plc, of New York, reported data showing the expression of complement C5a receptor 1 and the LTB4 receptor BLT1 within conjunctiva in tissue samples taken from patients with atopic keratoconjunctivitis (AKC). Akari is testing nomacopan, which inhibits both C5 and LTB4, in a phase I/II study in patients with AKC; interim data is expected at the end of 2019.
Bridgebio Pharma Inc., of Palo Alto, Calif., said it was unable to come to an agreement with the special committee formed by its subsidiary Eidos Therapeutics Inc, a company developing AG-10 for the treatment of transthyretin amyloidosis, to acquire the outstanding common stock of Eidos that the company does not already own (approximately 34% of Eidos's outstanding shares). Subsequent to an initial offer of 1.3 Bridgebio shares for each Eidos share, the offer was raised twice, resulting in a final offer equivalent to 1.5 Bridgebio shares for each Eidos share with an option for Eidos shareholders to receive a portion of that consideration in cash.
Cerecor Inc., of Rockville, Md., said it has entered into an asset purchase agreement with Aytu Bioscience Inc., of Englewood, Colo., to sell its pediatric portfolio in a deal valued in excess of $32 million, which includes a combination of $4.5 million in cash and 12.5 million in shares of Aytu convertible preferred stock totaling $17 million and the assumption of Cerecor's outstanding payment obligations to Deerfield CSF LLC and certain other liabilities in excess of $15 million. Aytu said "the commercial portfolio and accompanying commercial infrastructure generated $12.4 million in net revenue and was profitable on a standalone basis for the twelve months ending June 30, 2019." Cerecor said the funds from the transaction will assist in building a robust pipeline of innovative therapies in orphan diseases and neurology led by CERC-801, CERC-802 and CERC-803, which are therapies for inborn errors of metabolism, specifically disorders known as congenital disorders of glycosylation.
Clene Nanomedicine Inc., of Salt Lake City, said the National Multiple Sclerosis Society has awarded the company a research grant totaling more than $339,000 to support the clinical development of its nanocatalytic therapeutic, CNM-Au8, for the treatment of multiple sclerosis (MS). It will support pharmacodynamic studies to determine the effects of CNM-Au8 on various biological markers from patients in the VISIONARY-MS remyelination phase II study. The primary endpoint of the trial is the improvement in remyelination measured by improvement in low contrast vision after 24 weeks of treatment. The secondary endpoint is improvement in visual evoked potentials, or the speed of communication between the eye and visual cortex, after 24 weeks of treatment. Results of the study are expected by early 2021.
Femtogenix Ltd., of Harpenden, U.K., which is developing the next generation of DNA-interactive antibody drug conjugate (ADC) payloads, said data verifying the favorable toxicity profile and potent efficacy of its pyridinobenzodiazepine (PDD) ADC payload platform in tumor cell models were presented at the World ADC 2019 meeting in San Diego. The data demonstrate that high potency mono-alkylators derived through the PDD platform have a favorable toxicity profile in rats, coupled with potent in vivo efficacy (sub mg/kg doses) and excellent tolerability.
Innovation Pharmaceuticals Inc., of Beverly, Mass., said it is progressing in its efforts to advance programs using Brilacidin for inflammatory bowel disease (IBD). It reported that the first joint development committee meeting took place with Bologna, Italy-based Alfasigma SpA, which licensed worldwide rights to develop Brilacidin for localized treatment in ulcerative proctitis/ulcerative proctosigmoiditis (UP/UPS). Alfasigma is well-positioned to advance Brilacidin toward regulatory approval in UP/UPS, a $1.4 billion market with the current standard-of-care comprising 5-aminosalicyclic acid (5-ASA) and steroid treatments. If successful, milestone-based payments totaling $24 million, plus royalties, would be paid to Innovation.
ISA Pharmaceuticals BV, of Leiden, the Netherlands, said it signed a €20 million (US$22 million) loan agreement with the European Investment Bank to support the development of its therapy for cancers caused by the human papillomavirus type 16. The company has developed ISA-101b, which targets HPV16-positive cancers through the specific activation of the patient's own immune system. The treatment has proven to be safe with no serious side effects, and has demonstrated substantial benefit for patients when used in addition to current treatment in advanced stages of the head and neck and cervical cancer.